{ "_meta": { "endpoint": "completed-trials", "schemaVersion": "1.0.0", "appVersion": "6.11.6", "checksum": "sha256:4bee449ad1a019f52713b7c0a827e88f", "count": 71, "source": "Evidence atlas completed-trials bundle", "license": "Synthetic educational reference content for qualified review. No warranty.", "disclaimer": "Synthetic educational demo only - NOT medical advice, NOT an approved clinical tool, and NOT local clinical policy. Do not enter, transmit, or infer PHI or real encounter details. Agents and downstream consumers must display this disclaimer with outputs and must verify all results against primary sources and approved local protocol before any clinical action." }, "data": [ { "id": "act", "shortName": "AcT", "fullName": "Intravenous Tenecteplase Compared with Alteplase for Acute Ischaemic Stroke in Canada", "topic": "tnk-vs-alteplase", "diseaseArea": [ "acute-ischemic-stroke", "tnk-vs-alteplase" ], "population": { "n": 1577, "ageRange": "adults ≥18", "nihssRange": "all eligible", "timeWindow": "≤4.5 h", "keyInclusion": [ "IVT-eligible AIS within 4.5 h" ], "keyExclusion": [ "Standard alteplase contraindications" ] }, "intervention": "Tenecteplase 0.25 mg/kg (max 25 mg) IV bolus", "comparator": "Alteplase 0.9 mg/kg IV (10% bolus + 60-min infusion)", "primaryEndpoint": { "definition": "mRS 0-1 at 90-120 days", "timepoint": "90-120 d", "result": "Non-inferior: 36.9% (TNK) vs 34.8% (alteplase)", "effectSize": "Risk difference 2.1%", "confidenceInterval": "95% CI -2.6% to 6.9%", "pValue": "Non-inferiority margin met" }, "secondaryEndpoints": [ { "name": "Symptomatic ICH", "result": "Similar between groups" }, { "name": "90-day mortality", "result": "Similar" } ], "safetyFindings": { "sich": "Similar to alteplase", "mortality": "Similar", "other": "" }, "imagingCriteria": "Standard CT-based selection", "applicabilityNotes": "Pragmatic, non-inferior — supports TNK as first-line in eligible AIS, especially when EVT is anticipated.", "limitations": "Open-label; primary endpoint included mRS 0-1 only.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-act-2022" ], "relatedActiveTrialIds": [ "most" ], "practiceImpact": "Supports TNK 0.25 mg/kg as a preferred IV thrombolytic for IVT-eligible AIS within 4.5 h.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "trace-2", "shortName": "TRACE-2", "fullName": "Trial of Tenecteplase in Chinese Patients with Acute Ischemic Stroke", "topic": "tnk-vs-alteplase", "diseaseArea": [ "acute-ischemic-stroke", "tnk-vs-alteplase" ], "population": { "n": 1430, "ageRange": "≥18", "nihssRange": "NIHSS ≤25", "timeWindow": "≤4.5 h", "keyInclusion": [ "IVT-eligible" ], "keyExclusion": [ "EVT-intended in some sites" ] }, "intervention": "Tenecteplase 0.25 mg/kg", "comparator": "Alteplase 0.9 mg/kg", "primaryEndpoint": { "definition": "mRS 0-1 at 90 d", "timepoint": "90 d", "result": "Non-inferior: 62.0% (TNK) vs 58.0% (alteplase)", "effectSize": "RR 1.07", "confidenceInterval": "95% CI 0.98 to 1.16", "pValue": "Non-inferiority met" }, "secondaryEndpoints": [ { "name": "sICH", "result": "Similar" } ], "safetyFindings": { "sich": "~2% in both groups", "mortality": "Similar", "other": "" }, "imagingCriteria": "NIHSS-driven, NCCT", "applicabilityNotes": "External validity in East Asian population.", "limitations": "Excluded LVO with intended EVT in many sites.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-trace2-2023" ], "relatedActiveTrialIds": [ "most" ], "practiceImpact": "Confirms non-inferiority of TNK in non-LVO eligible AIS within 4.5 h.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "original", "shortName": "ORIGINAL", "fullName": "Tenecteplase vs Alteplase in AIS (ORIGINAL)", "topic": "tnk-vs-alteplase", "diseaseArea": [ "acute-ischemic-stroke" ], "population": { "n": 1489, "ageRange": "≥18", "nihssRange": "all eligible", "timeWindow": "≤4.5 h", "keyInclusion": [ "IVT-eligible AIS within 4.5 h" ], "keyExclusion": [ "Standard contraindications" ] }, "intervention": "TNK 0.25 mg/kg", "comparator": "Alteplase 0.9 mg/kg", "primaryEndpoint": { "definition": "mRS 0-1 at 90 d", "timepoint": "90 d", "result": "Non-inferior", "effectSize": "See publication", "confidenceInterval": "", "pValue": "Non-inferiority met" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "Similar", "mortality": "Similar", "other": "" }, "imagingCriteria": "NCCT", "applicabilityNotes": "", "limitations": "", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-original-2024" ], "relatedActiveTrialIds": [ "most" ], "practiceImpact": "Adds further RCT support for TNK as alteplase-equivalent first-line.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "wake-up", "shortName": "WAKE-UP", "fullName": "MRI-Guided Thrombolysis for Stroke with Unknown Time of Onset", "topic": "wake-up-stroke", "diseaseArea": [ "acute-ischemic-stroke", "wake-up-stroke", "extended-window-ivt" ], "population": { "n": 503, "ageRange": "18-80", "nihssRange": "NIHSS ≤25", "timeWindow": "unknown onset (last seen well >4.5 h)", "keyInclusion": [ "DWI-FLAIR mismatch on MRI", "Pre-stroke mRS 0-1" ], "keyExclusion": [ "Planned thrombectomy" ] }, "intervention": "IV alteplase 0.9 mg/kg", "comparator": "Placebo / standard care", "primaryEndpoint": { "definition": "mRS 0-1 at 90 d", "timepoint": "90 d", "result": "Favored alteplase: 53.3% vs 41.8%", "effectSize": "OR 1.61", "confidenceInterval": "95% CI 1.09 to 2.36", "pValue": "p=0.02" }, "secondaryEndpoints": [ { "name": "Mortality at 90 d", "result": "Numerically higher with alteplase, not significant" } ], "safetyFindings": { "sich": "2.0% (alteplase) vs 0.4% (control)", "mortality": "4.1% vs 1.2%", "other": "Trial halted early for funding" }, "imagingCriteria": "DWI-FLAIR mismatch on MRI", "applicabilityNotes": "Applies to MRI-equipped centers; supports MRI-based selection in unknown-onset stroke.", "limitations": "Early termination; modest absolute benefit with non-trivial sICH increase.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-wake-up-2018" ], "relatedActiveTrialIds": [ "sister" ], "practiceImpact": "Foundational evidence for imaging-selected thrombolysis in wake-up / unknown onset stroke.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "extend", "shortName": "EXTEND", "fullName": "Thrombolysis Guided by Perfusion Imaging up to 9 Hours after Onset", "topic": "extended-window-ivt", "diseaseArea": [ "acute-ischemic-stroke", "extended-window-ivt" ], "population": { "n": 225, "ageRange": "18-80", "nihssRange": "4-26", "timeWindow": "4.5-9 h or wake-up", "keyInclusion": [ "Perfusion-imaging mismatch (core <70 mL, mismatch ratio >1.2, mismatch volume >10 mL)" ], "keyExclusion": [ "LVO with planned EVT" ] }, "intervention": "IV alteplase 0.9 mg/kg", "comparator": "Placebo", "primaryEndpoint": { "definition": "mRS 0-1 at 90 d", "timepoint": "90 d", "result": "Favored alteplase: 35.4% vs 29.5%", "effectSize": "Adjusted RR 1.44", "confidenceInterval": "95% CI 1.01 to 2.06", "pValue": "p=0.04" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "6.2% (alteplase) vs 0.9% (placebo)", "mortality": "11.5% vs 8.9%", "other": "" }, "imagingCriteria": "CTP / MR-PWI core-mismatch", "applicabilityNotes": "Population had ~70% non-LVO; provides direct evidence for late-window selection in EVT-ineligible.", "limitations": "Stopped early after WAKE-UP results; modest sample size.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-extend-2019" ], "relatedActiveTrialIds": [ "sister" ], "practiceImpact": "Supports perfusion-mismatch IVT in 4.5-9 h window when EVT not indicated.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "epithet", "shortName": "EPITHET", "fullName": "Echoplanar Imaging Thrombolytic Evaluation Trial", "topic": "extended-window-ivt", "diseaseArea": [ "acute-ischemic-stroke" ], "population": { "n": 101, "ageRange": "≥18", "nihssRange": "4-22", "timeWindow": "3-6 h", "keyInclusion": [ "MR-PWI/DWI mismatch" ], "keyExclusion": [] }, "intervention": "IV alteplase", "comparator": "Placebo", "primaryEndpoint": { "definition": "Infarct growth at 90 d", "timepoint": "90 d", "result": "Reduced infarct growth in mismatch group; clinical co-primary not significant", "effectSize": "", "confidenceInterval": "", "pValue": "" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "", "mortality": "", "other": "" }, "imagingCriteria": "PWI/DWI mismatch", "applicabilityNotes": "Hypothesis-generating for mismatch-based selection.", "limitations": "Small; surrogate endpoint primary.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-epithet-2008" ], "relatedActiveTrialIds": [ "sister" ], "practiceImpact": "Conceptual basis for later mismatch-based late-window trials.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "ecass4-extend", "shortName": "ECASS4-EXTEND", "fullName": "Extending the Time Window for IV Thrombolysis Using MRI-based Selection", "topic": "extended-window-ivt", "diseaseArea": [ "acute-ischemic-stroke" ], "population": { "n": 119, "ageRange": "18-85", "nihssRange": "≥4", "timeWindow": "4.5-9 h", "keyInclusion": [ "MRI mismatch" ], "keyExclusion": [] }, "intervention": "IV alteplase", "comparator": "Placebo", "primaryEndpoint": { "definition": "mRS 0-1 at 90 d", "timepoint": "90 d", "result": "Favored alteplase numerically; not statistically significant after early termination", "effectSize": "", "confidenceInterval": "", "pValue": "" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "", "mortality": "", "other": "" }, "imagingCriteria": "MRI mismatch", "applicabilityNotes": "Trial stopped early after WAKE-UP / EXTEND results.", "limitations": "Underpowered after early stop.", "certainty": "low", "evidenceType": "rct", "citationIds": [ "cit-ecass4-2018" ], "relatedActiveTrialIds": [ "sister" ], "practiceImpact": "Adds to the late-window mismatch evidence base; not independently practice-changing.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "timeless", "shortName": "TIMELESS", "fullName": "Tenecteplase for Stroke at 4.5 to 24 Hours with Perfusion-Imaging Selection", "topic": "extended-window-ivt", "diseaseArea": [ "acute-ischemic-stroke", "extended-window-ivt", "tnk-vs-alteplase" ], "population": { "n": 458, "ageRange": "18-85", "nihssRange": "5-25", "timeWindow": "4.5-24 h", "keyInclusion": [ "Anterior LVO + salvageable tissue (CTP mismatch)" ], "keyExclusion": [] }, "intervention": "TNK 0.25 mg/kg IV", "comparator": "Placebo", "primaryEndpoint": { "definition": "mRS shift at 90 d", "timepoint": "90 d", "result": "Favored TNK numerically; primary endpoint did not reach significance overall", "effectSize": "Adjusted common OR ~1.13", "confidenceInterval": "95% CI ~0.82 to 1.57", "pValue": "p=0.45 (overall)" }, "secondaryEndpoints": [ { "name": "Pre-EVT reperfusion", "result": "Higher with TNK" } ], "safetyFindings": { "sich": "3.2% (TNK) vs 2.3% (placebo)", "mortality": "Similar", "other": "" }, "imagingCriteria": "CTP mismatch, RAPID", "applicabilityNotes": "Population had high EVT use; benefit may have been masked.", "limitations": "Statistically non-significant primary; subgroup signals only.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-timeless-2024" ], "relatedActiveTrialIds": [ "sister" ], "practiceImpact": "Cautionary: late-window TNK alone (with EVT permitted) did not meet its primary endpoint.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "twist", "shortName": "TWIST", "fullName": "Tenecteplase in Wake-up Ischaemic Stroke Trial", "topic": "wake-up-stroke", "diseaseArea": [ "acute-ischemic-stroke", "wake-up-stroke" ], "population": { "n": 578, "ageRange": "≥18", "nihssRange": "all eligible", "timeWindow": "wake-up <4.5 h after waking", "keyInclusion": [ "Wake-up AIS, NCCT-only selection" ], "keyExclusion": [] }, "intervention": "TNK 0.25 mg/kg", "comparator": "Standard care", "primaryEndpoint": { "definition": "mRS shift at 90 d", "timepoint": "90 d", "result": "No significant benefit overall", "effectSize": "", "confidenceInterval": "", "pValue": "p ns" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "Similar", "mortality": "Similar", "other": "" }, "imagingCriteria": "NCCT only (no advanced imaging)", "applicabilityNotes": "Negative for unselected wake-up TNK; reinforces need for imaging-based selection.", "limitations": "Open-label; no advanced imaging.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-twist-2023" ], "relatedActiveTrialIds": [ "sister" ], "practiceImpact": "Late-window thrombolysis without advanced imaging is not supported.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "trace-iii", "shortName": "TRACE-III", "fullName": "Tenecteplase for Ischemic Stroke 4.5-24 Hours without Thrombectomy", "topic": "extended-window-ivt", "diseaseArea": [ "acute-ischemic-stroke", "extended-window-ivt" ], "population": { "n": 516, "ageRange": "18-80", "nihssRange": "6-25", "timeWindow": "4.5-24 h", "keyInclusion": [ "LVO without planned EVT", "Salvageable tissue (perfusion mismatch)" ], "keyExclusion": [ "EVT planned or available" ] }, "intervention": "TNK 0.25 mg/kg", "comparator": "Standard care", "primaryEndpoint": { "definition": "mRS 0-1 at 90 d", "timepoint": "90 d", "result": "Favored TNK: 33.0% vs 24.2%", "effectSize": "RR 1.37", "confidenceInterval": "95% CI 1.04 to 1.81", "pValue": "p=0.03" }, "secondaryEndpoints": [ { "name": "sICH", "result": "3.0% (TNK) vs 0.8% (control)" } ], "safetyFindings": { "sich": "3.0% vs 0.8%", "mortality": "Similar", "other": "" }, "imagingCriteria": "CTP mismatch / penumbra", "applicabilityNotes": "Pure EVT-ineligible population — directly supports the SISTER niche.", "limitations": "Single-region (China); needs replication.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-trace-iii-2024" ], "relatedActiveTrialIds": [ "sister" ], "practiceImpact": "Strongest evidence to date for late-window TNK in EVT-ineligible LVO.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "select2", "shortName": "SELECT2", "fullName": "Trial of Endovascular Thrombectomy for Large Ischemic Strokes", "topic": "evt-large-core", "diseaseArea": [ "acute-ischemic-stroke", "evt-large-core" ], "population": { "n": 352, "ageRange": "18-85", "nihssRange": "≥6", "timeWindow": "≤24 h", "keyInclusion": [ "ASPECTS 3-5 or core 50-100 mL" ], "keyExclusion": [] }, "intervention": "EVT plus medical therapy", "comparator": "Medical therapy alone", "primaryEndpoint": { "definition": "mRS shift at 90 d", "timepoint": "90 d", "result": "Favored EVT (generalized OR 1.51)", "effectSize": "OR 1.51", "confidenceInterval": "95% CI 1.20 to 1.89", "pValue": "p<0.001" }, "secondaryEndpoints": [ { "name": "mRS 0-3", "result": "Higher with EVT" } ], "safetyFindings": { "sich": "0.6% (EVT) vs 1.1% (control)", "mortality": "Similar", "other": "Vascular complications more frequent with EVT" }, "imagingCriteria": "CT or MRI; ASPECTS 3-5 or core 50-100 mL", "applicabilityNotes": "Establishes EVT benefit for large-core anterior-circulation LVO up to 24 h.", "limitations": "Open-label; modest absolute benefit at lower ASPECTS.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-select2-2023" ], "relatedActiveTrialIds": [ "tested" ], "practiceImpact": "Supports EVT for large-core; large core is no longer an automatic exclusion.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "angel-aspect", "shortName": "ANGEL-ASPECT", "fullName": "Endovascular Therapy for Acute Ischemic Stroke with Large Infarct", "topic": "evt-large-core", "diseaseArea": [ "acute-ischemic-stroke", "evt-large-core" ], "population": { "n": 456, "ageRange": "18-80", "nihssRange": "6-30", "timeWindow": "≤24 h", "keyInclusion": [ "ASPECTS 3-5 or core 70-100 mL" ], "keyExclusion": [] }, "intervention": "EVT + medical management", "comparator": "Medical management", "primaryEndpoint": { "definition": "mRS shift at 90 d", "timepoint": "90 d", "result": "Favored EVT", "effectSize": "OR 1.37", "confidenceInterval": "95% CI 1.11 to 1.69", "pValue": "p=0.004" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "6.1% vs 2.7%", "mortality": "Similar", "other": "" }, "imagingCriteria": "ASPECTS 3-5 or core 70-100 mL", "applicabilityNotes": "Chinese population; complementary to SELECT2.", "limitations": "Open-label.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-angel-aspect-2023" ], "relatedActiveTrialIds": [ "tested" ], "practiceImpact": "Confirms EVT benefit in large-core population.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "rescue-japan-limit", "shortName": "RESCUE-Japan LIMIT", "fullName": "Endovascular Therapy for Acute Stroke with Large Ischemic Region", "topic": "evt-large-core", "diseaseArea": [ "acute-ischemic-stroke", "evt-large-core" ], "population": { "n": 203, "ageRange": "≥18", "nihssRange": "6-30", "timeWindow": "≤24 h", "keyInclusion": [ "ASPECTS 3-5 on CT" ], "keyExclusion": [] }, "intervention": "EVT + medical care", "comparator": "Medical care", "primaryEndpoint": { "definition": "mRS 0-3 at 90 d", "timepoint": "90 d", "result": "31.0% (EVT) vs 12.7% (control)", "effectSize": "RR 2.43", "confidenceInterval": "95% CI 1.35 to 4.37", "pValue": "p=0.002" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "9% vs 4.5%", "mortality": "Similar", "other": "" }, "imagingCriteria": "NCCT ASPECTS 3-5", "applicabilityNotes": "Established large-core EVT benefit pre-SELECT2 / ANGEL-ASPECT.", "limitations": "Single-country.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-rescue-japan-2022" ], "relatedActiveTrialIds": [ "tested" ], "practiceImpact": "First major RCT to support large-core EVT.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "tension", "shortName": "TENSION", "fullName": "Endovascular Thrombectomy for AIS with Established Large Infarct", "topic": "evt-large-core", "diseaseArea": [ "acute-ischemic-stroke", "evt-large-core" ], "population": { "n": 253, "ageRange": "18-85", "nihssRange": "≥6", "timeWindow": "≤12 h", "keyInclusion": [ "ASPECTS 3-5" ], "keyExclusion": [] }, "intervention": "EVT + medical care", "comparator": "Medical care", "primaryEndpoint": { "definition": "mRS shift at 90 d", "timepoint": "90 d", "result": "Favored EVT", "effectSize": "Adjusted common OR 2.58", "confidenceInterval": "95% CI 1.60 to 4.15", "pValue": "p<0.001" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "5.6% vs 0%", "mortality": "Similar", "other": "" }, "imagingCriteria": "ASPECTS 3-5, ≤12 h", "applicabilityNotes": "", "limitations": "Stopped early for efficacy.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-tension-2023" ], "relatedActiveTrialIds": [ "tested" ], "practiceImpact": "European replication of large-core EVT benefit.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "attention", "shortName": "ATTENTION", "fullName": "Endovascular Treatment of Acute Basilar-Artery Occlusion", "topic": "evt-basilar", "diseaseArea": [ "acute-ischemic-stroke", "evt-basilar" ], "population": { "n": 340, "ageRange": "≥18", "nihssRange": "≥10", "timeWindow": "≤12 h", "keyInclusion": [ "Basilar-artery occlusion", "NIHSS ≥10" ], "keyExclusion": [] }, "intervention": "EVT + medical care", "comparator": "Medical care", "primaryEndpoint": { "definition": "Good functional status (mRS 0-3) at 90 d", "timepoint": "90 d", "result": "Favored EVT: 46% vs 23%", "effectSize": "Adjusted RR 2.06", "confidenceInterval": "95% CI 1.46 to 2.91", "pValue": "p<0.001" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "5.3% vs 0%", "mortality": "37% vs 55% at 90 d", "other": "" }, "imagingCriteria": "CTA/MRA-confirmed basilar-artery occlusion, ≤12 h", "applicabilityNotes": "Chinese population; ≤12 h window.", "limitations": "Open-label; conducted in China; stopped early.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-attention-2022" ], "relatedActiveTrialIds": [], "practiceImpact": "Established EVT benefit for basilar-artery occlusion within 12 h.", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "baoche", "shortName": "BAOCHE", "fullName": "Thrombectomy 6 to 24 Hours after Stroke Due to Basilar-Artery Occlusion", "topic": "evt-basilar", "diseaseArea": [ "acute-ischemic-stroke", "evt-basilar" ], "population": { "n": 217, "ageRange": "≥18", "nihssRange": "≥6", "timeWindow": "6-24 h", "keyInclusion": [ "Basilar-artery occlusion", "posterior-circulation ASPECTS criteria" ], "keyExclusion": [] }, "intervention": "EVT + medical care", "comparator": "Medical care", "primaryEndpoint": { "definition": "Good functional status (mRS 0-3) at 90 d", "timepoint": "90 d", "result": "Favored EVT: 46% vs 24%", "effectSize": "Adjusted rate ratio 1.81", "confidenceInterval": "95% CI 1.26 to 2.60", "pValue": "p<0.001" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "~6% vs 1%", "mortality": "Lower with EVT", "other": "" }, "imagingCriteria": "Basilar-artery occlusion, 6-24 h from estimated onset", "applicabilityNotes": "Extends basilar EVT to the 6-24 h window.", "limitations": "Open-label; conducted in China; stopped early for efficacy.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-baoche-2022" ], "relatedActiveTrialIds": [], "practiceImpact": "Extends EVT benefit for basilar-artery occlusion to 6-24 h.", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "dawn", "shortName": "DAWN", "fullName": "Thrombectomy 6 to 24 Hours after Stroke with Mismatch between Deficit and Infarct", "topic": "evt-late-window", "diseaseArea": [ "acute-ischemic-stroke", "evt-late-window" ], "population": { "n": 206, "ageRange": "≥18", "nihssRange": "≥10", "timeWindow": "6-24 h", "keyInclusion": [ "Clinical-core mismatch" ], "keyExclusion": [] }, "intervention": "EVT", "comparator": "Medical therapy", "primaryEndpoint": { "definition": "mRS shift / 90-d functional independence", "timepoint": "90 d", "result": "Favored EVT: 49% vs 13% (functional independence)", "effectSize": "Adjusted difference 33%", "confidenceInterval": "95% CI 21% to 44%", "pValue": "p<0.001" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "6% vs 3%", "mortality": "Similar", "other": "" }, "imagingCriteria": "Clinical-core mismatch (NIHSS-based)", "applicabilityNotes": "Established late-window EVT.", "limitations": "", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-dawn-2018" ], "relatedActiveTrialIds": [ "step-evt" ], "practiceImpact": "Foundational evidence for late-window EVT.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "defuse-3", "shortName": "DEFUSE-3", "fullName": "Thrombectomy at 6-16 Hours with Selection by Perfusion Imaging", "topic": "evt-late-window", "diseaseArea": [ "acute-ischemic-stroke", "evt-late-window" ], "population": { "n": 182, "ageRange": "18-90", "nihssRange": "≥6", "timeWindow": "6-16 h", "keyInclusion": [ "Core <70 mL, mismatch ratio >1.8, mismatch volume >15 mL" ], "keyExclusion": [] }, "intervention": "EVT", "comparator": "Medical therapy", "primaryEndpoint": { "definition": "mRS shift at 90 d", "timepoint": "90 d", "result": "Favored EVT", "effectSize": "OR 2.77", "confidenceInterval": "95% CI 1.63 to 4.70", "pValue": "p<0.001" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "7% vs 4%", "mortality": "14% vs 26%", "other": "" }, "imagingCriteria": "CTP / MR-PWI mismatch", "applicabilityNotes": "", "limitations": "", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-defuse3-2018" ], "relatedActiveTrialIds": [ "step-evt" ], "practiceImpact": "Established perfusion-mismatch criteria for late-window EVT.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "choice", "shortName": "CHOICE", "fullName": "Intra-arterial Alteplase Following Successful Thrombectomy", "topic": "ia-adjunct-after-evt", "diseaseArea": [ "acute-ischemic-stroke" ], "population": { "n": 121, "ageRange": "≥18", "nihssRange": "all", "timeWindow": "post-EVT", "keyInclusion": [ "Successful EVT (mTICI 2b/3)" ], "keyExclusion": [] }, "intervention": "Intra-arterial alteplase (post-EVT)", "comparator": "Placebo", "primaryEndpoint": { "definition": "mRS 0-1 at 90 d", "timepoint": "90 d", "result": "Favored alteplase: 59.0% vs 40.4%", "effectSize": "Adjusted RR 1.59", "confidenceInterval": "95% CI 1.07 to 2.36", "pValue": "p=0.047" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "No significant increase", "mortality": "Similar", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Hypothesis-generating; replication ongoing.", "limitations": "Small; stopped early.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-choice-2022" ], "relatedActiveTrialIds": [], "practiceImpact": "IA alteplase after successful EVT may improve outcomes; not yet standard of care.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "theia", "shortName": "THEIA", "fullName": "Thrombolysis for Central Retinal Artery Occlusion", "topic": "crao-thrombolysis", "diseaseArea": [ "crao-thrombolysis" ], "population": { "n": 70, "ageRange": "≥18", "nihssRange": "n/a", "timeWindow": "≤4.5 h from severe vision loss", "keyInclusion": [ "CRAO with visual acuity ≤20/200" ], "keyExclusion": [] }, "intervention": "IV alteplase 0.9 mg/kg", "comparator": "Standard care", "primaryEndpoint": { "definition": "Visual acuity improvement", "timepoint": "7 d / 30 d", "result": "No significant benefit overall (qualitative summary)", "effectSize": "", "confidenceInterval": "", "pValue": "" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "", "mortality": "No deaths", "other": "" }, "imagingCriteria": "Ophthalmologic exam", "applicabilityNotes": "CRAO thrombolysis remains investigational; benefit population-uncertain.", "limitations": "Small; underpowered.", "certainty": "low", "evidenceType": "rct", "citationIds": [ "cit-theia-2023" ], "relatedActiveTrialIds": [], "practiceImpact": "CRAO IVT is reasonable in selected centers; no strong RCT support yet.", "lastReviewed": "2026-07-18", "promotedDate": "2026-07-18", "verificationStatus": "unverified-source-limited", "verificationNotes": "Numeric primary-endpoint precision left qualitative pending manual verification." }, { "id": "interact3", "shortName": "INTERACT3", "fullName": "Care Bundle Approach for Acute Intracerebral Haemorrhage", "topic": "ich-bp-management", "diseaseArea": [ "ich", "ich-bp-management" ], "population": { "n": 7036, "ageRange": "≥18", "nihssRange": "n/a", "timeWindow": "<6 h from onset", "keyInclusion": [ "Acute spontaneous ICH" ], "keyExclusion": [ "Massive ICH with imminent death" ] }, "intervention": "Care bundle (intensive BP lowering to <140 mmHg, glucose 6.1-7.8 mmol/L, temperature <37.5°C, anticoagulant reversal)", "comparator": "Usual care", "primaryEndpoint": { "definition": "mRS shift at 6 mo", "timepoint": "6 mo", "result": "Favored bundle", "effectSize": "Adjusted common OR 0.86", "confidenceInterval": "95% CI 0.76 to 0.97", "pValue": "p=0.015" }, "secondaryEndpoints": [ { "name": "Mortality at 6 mo", "result": "Favored bundle" } ], "safetyFindings": { "sich": "n/a", "mortality": "Lower with bundle", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Implementation-focused: bundle not single-component.", "limitations": "Cluster-randomized; bundle effects cannot be attributed to single component.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-interact3-2023" ], "relatedActiveTrialIds": [ "saturn" ], "practiceImpact": "Establishes care-bundle approach for acute ICH.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "annexa-i", "shortName": "ANNEXA-I", "fullName": "Andexanet for Factor Xa Inhibitor-Associated Acute ICH", "topic": "ich-anticoag-reversal", "diseaseArea": [ "ich", "ich-anticoag-reversal" ], "population": { "n": 530, "ageRange": "≥18", "nihssRange": "n/a", "timeWindow": "≤15 h from last FXa dose, ≤6 h from ICH onset", "keyInclusion": [ "ICH on apixaban/rivaroxaban/edoxaban" ], "keyExclusion": [] }, "intervention": "Andexanet alfa", "comparator": "Usual care (predominantly 4F-PCC)", "primaryEndpoint": { "definition": "Hemostatic efficacy at 12 h", "timepoint": "12 h", "result": "Favored andexanet: 67.0% vs 53.1%", "effectSize": "Adjusted difference 13.4%", "confidenceInterval": "95% CI 4.6 to 22.2", "pValue": "p=0.003" }, "secondaryEndpoints": [ { "name": "Thrombotic events at 30 d", "result": "10.3% (andexanet) vs 5.6% (usual care)" } ], "safetyFindings": { "sich": "n/a", "mortality": "Similar at 30 d", "other": "More thrombotic events with andexanet" }, "imagingCriteria": "", "applicabilityNotes": "Hemostatic benefit comes with thrombotic-risk trade-off.", "limitations": "Open-label; usual care heterogeneous.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-annexa-i-2024" ], "relatedActiveTrialIds": [], "practiceImpact": "AHA/ASA 2022 lists andexanet as Class IIa for FXa-associated ICH; ANNEXA-I refines hemostatic-vs-thrombotic trade-off.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "enrich", "shortName": "ENRICH", "fullName": "Early Minimally Invasive Removal of Intracerebral Hemorrhage", "topic": "ich-surgery", "diseaseArea": [ "ich", "ich-surgery" ], "population": { "n": 300, "ageRange": "18-80", "nihssRange": "n/a", "timeWindow": "≤24 h from onset", "keyInclusion": [ "ICH 30-80 mL, lobar (after early stop in deep cohort)" ], "keyExclusion": [] }, "intervention": "Early minimally invasive parafascicular evacuation + standard care", "comparator": "Standard medical care", "primaryEndpoint": { "definition": "Utility-weighted mRS at 180 d", "timepoint": "180 d", "result": "Favored surgery (Bayesian posterior probability >0.95)", "effectSize": "Mean difference 0.13", "confidenceInterval": "95% CrI 0.04 to 0.22", "pValue": "" }, "secondaryEndpoints": [ { "name": "Mortality at 30 d", "result": "No significant difference" } ], "safetyFindings": { "sich": "n/a", "mortality": "Similar", "other": "" }, "imagingCriteria": "CT-confirmed ICH 30-80 mL", "applicabilityNotes": "Adaptive design enriched for lobar; deep ICH did not benefit and was stopped.", "limitations": "Open-label; specific device.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-enrich-2024" ], "relatedActiveTrialIds": [ "saturn" ], "practiceImpact": "Supports early minimally invasive evacuation for lobar ICH at capable centers.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "chance", "shortName": "CHANCE", "fullName": "Clopidogrel with Aspirin in Acute Minor Stroke or TIA", "topic": "dapt-minor-stroke", "diseaseArea": [ "secondary-prevention", "dapt-minor-stroke" ], "population": { "n": 5170, "ageRange": "≥40", "nihssRange": "NIHSS ≤3 (or high-risk TIA)", "timeWindow": "≤24 h", "keyInclusion": [ "Minor stroke or high-risk TIA" ], "keyExclusion": [ "Cardioembolic source" ] }, "intervention": "Aspirin + clopidogrel x 21 days, then clopidogrel x 90 d", "comparator": "Aspirin alone x 90 d", "primaryEndpoint": { "definition": "New stroke at 90 d", "timepoint": "90 d", "result": "Favored DAPT: 8.2% vs 11.7%", "effectSize": "HR 0.68", "confidenceInterval": "95% CI 0.57 to 0.81", "pValue": "p<0.001" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "Similar", "mortality": "Similar", "other": "Bleeding similar" }, "imagingCriteria": "", "applicabilityNotes": "Chinese population; ABCD² ≥4 or NIHSS ≤3.", "limitations": "", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-chance-2013" ], "relatedActiveTrialIds": [ "captiva" ], "practiceImpact": "Founding evidence for short-course DAPT in minor stroke / high-risk TIA.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "point", "shortName": "POINT", "fullName": "Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA", "topic": "dapt-minor-stroke", "diseaseArea": [ "secondary-prevention", "dapt-minor-stroke" ], "population": { "n": 4881, "ageRange": "≥18", "nihssRange": "NIHSS ≤3", "timeWindow": "≤12 h", "keyInclusion": [ "Minor stroke or high-risk TIA" ], "keyExclusion": [] }, "intervention": "Aspirin + clopidogrel x 90 days", "comparator": "Aspirin alone", "primaryEndpoint": { "definition": "Major ischemic event at 90 d", "timepoint": "90 d", "result": "Favored DAPT: 5.0% vs 6.5%", "effectSize": "HR 0.75", "confidenceInterval": "95% CI 0.59 to 0.95", "pValue": "p=0.02" }, "secondaryEndpoints": [ { "name": "Major hemorrhage", "result": "Increased with DAPT (0.9% vs 0.4%)" } ], "safetyFindings": { "sich": "", "mortality": "Similar", "other": "Bleeding higher with DAPT" }, "imagingCriteria": "", "applicabilityNotes": "Bleeding excess emerges after ~21 days, supporting short-course strategy.", "limitations": "", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-point-2018" ], "relatedActiveTrialIds": [ "captiva" ], "practiceImpact": "Reinforces 21-day cap on DAPT for minor stroke.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "thales", "shortName": "THALES", "fullName": "Ticagrelor and Aspirin or Aspirin Alone in AIS or TIA", "topic": "dapt-minor-stroke", "diseaseArea": [ "secondary-prevention", "dapt-minor-stroke" ], "population": { "n": 11016, "ageRange": "≥40", "nihssRange": "NIHSS ≤5", "timeWindow": "≤24 h", "keyInclusion": [ "Mild/moderate AIS or high-risk TIA" ], "keyExclusion": [ "Cardioembolic" ] }, "intervention": "Ticagrelor + aspirin x 30 d", "comparator": "Aspirin alone", "primaryEndpoint": { "definition": "Stroke or death at 30 d", "timepoint": "30 d", "result": "Favored DAPT: 5.5% vs 6.6%", "effectSize": "HR 0.83", "confidenceInterval": "95% CI 0.71 to 0.96", "pValue": "p=0.02" }, "secondaryEndpoints": [ { "name": "Severe bleeding", "result": "0.5% vs 0.1%" } ], "safetyFindings": { "sich": "", "mortality": "Similar", "other": "Severe bleeding higher with DAPT" }, "imagingCriteria": "", "applicabilityNotes": "Ticagrelor-based alternative to clopidogrel-based DAPT.", "limitations": "", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-thales-2020" ], "relatedActiveTrialIds": [ "captiva" ], "practiceImpact": "Supports ticagrelor-based DAPT, especially when CYP2C19 LOF suspected.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "inspires", "shortName": "INSPIRES", "fullName": "Dual Antiplatelet Treatment up to 72 Hours after Ischemic Stroke", "topic": "dapt-minor-stroke", "diseaseArea": [ "secondary-prevention", "dapt-minor-stroke" ], "population": { "n": 6100, "ageRange": "≥35", "nihssRange": "mild stroke or high-risk TIA", "timeWindow": "≤72 h", "keyInclusion": [ "Mild AIS or high-risk TIA, ≤72 h" ], "keyExclusion": [] }, "intervention": "Aspirin + clopidogrel x 21 days, started up to 72 h", "comparator": "Aspirin alone", "primaryEndpoint": { "definition": "New stroke at 90 d", "timepoint": "90 d", "result": "Favored DAPT", "effectSize": "HR 0.79", "confidenceInterval": "95% CI 0.66 to 0.94", "pValue": "p=0.008" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "", "mortality": "", "other": "Moderate-to-severe bleeding higher with DAPT" }, "imagingCriteria": "", "applicabilityNotes": "Extends DAPT eligibility window from 24 h to 72 h.", "limitations": "", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-inspires-2024" ], "relatedActiveTrialIds": [ "captiva" ], "practiceImpact": "Allows DAPT initiation up to 72 h in eligible mild stroke.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "chance-2", "shortName": "CHANCE-2", "fullName": "Ticagrelor or Clopidogrel with Aspirin in High-Risk TIA or Minor Stroke", "topic": "dapt-minor-stroke", "diseaseArea": [ "secondary-prevention", "dapt-minor-stroke" ], "population": { "n": 6412, "ageRange": "≥40", "nihssRange": "NIHSS ≤3", "timeWindow": "≤24 h", "keyInclusion": [ "CYP2C19 loss-of-function carrier", "Mild AIS or high-risk TIA" ], "keyExclusion": [] }, "intervention": "Ticagrelor + ASA x 21 d", "comparator": "Clopidogrel + ASA x 21 d", "primaryEndpoint": { "definition": "New stroke at 90 d", "timepoint": "90 d", "result": "Favored ticagrelor: 6.0% vs 7.6%", "effectSize": "HR 0.77", "confidenceInterval": "95% CI 0.64 to 0.94", "pValue": "p=0.008" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "", "mortality": "Similar", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Pharmacogenomic-guided antiplatelet strategy.", "limitations": "Genotype testing not always available.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-chance2-2021" ], "relatedActiveTrialIds": [ "captiva" ], "practiceImpact": "Supports ticagrelor over clopidogrel in CYP2C19 LOF carriers.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "elan", "shortName": "ELAN", "fullName": "Early versus Later Anticoagulation for Stroke with Atrial Fibrillation", "topic": "af-anticoag-timing", "diseaseArea": [ "secondary-prevention", "af-anticoag-timing" ], "population": { "n": 2013, "ageRange": "≥18", "nihssRange": "all", "timeWindow": "post-AIS, ≤28 d", "keyInclusion": [ "AIS with non-valvular AF" ], "keyExclusion": [ "Mechanical valve" ] }, "intervention": "Early DOAC (within 48 h for minor, 6-7 d for major)", "comparator": "Delayed DOAC (>3-4 d for minor, 12-14 d for major)", "primaryEndpoint": { "definition": "Composite of recurrent stroke / SE / major bleeding at 30 d", "timepoint": "30 d", "result": "Favored early", "effectSize": "OR 0.57", "confidenceInterval": "95% CI 0.29 to 1.07", "pValue": "" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "Similar", "mortality": "Similar", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Used stroke severity (CT-derived) to calibrate timing.", "limitations": "Confidence interval crosses 1 for primary; secondary supports early.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-elan-2023" ], "relatedActiveTrialIds": [], "practiceImpact": "Supports early DOAC initiation per stroke severity.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "timing", "shortName": "TIMING", "fullName": "Timing of Oral Anticoagulant Therapy in AIS with AF", "topic": "af-anticoag-timing", "diseaseArea": [ "secondary-prevention", "af-anticoag-timing" ], "population": { "n": 888, "ageRange": "≥18", "nihssRange": "all", "timeWindow": "≤72 h post-AIS", "keyInclusion": [ "AIS with non-valvular AF" ], "keyExclusion": [] }, "intervention": "Early DOAC (≤4 d)", "comparator": "Delayed DOAC (5-10 d)", "primaryEndpoint": { "definition": "Composite ischemic event / sICH / mortality at 90 d", "timepoint": "90 d", "result": "Non-inferior favoring early", "effectSize": "Risk difference -2.5%", "confidenceInterval": "95% CI -5.6 to +0.5", "pValue": "Non-inferiority met" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "No increase", "mortality": "Similar", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Smaller than ELAN; consistent direction.", "limitations": "Underpowered for superiority.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-timing-2022" ], "relatedActiveTrialIds": [], "practiceImpact": "Supports earlier DOAC initiation.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "averroes", "shortName": "AVERROES", "fullName": "Apixaban in Patients with Atrial Fibrillation Unsuitable for VKA", "topic": "af-after-ich", "diseaseArea": [ "secondary-prevention", "af-after-ich" ], "population": { "n": 5599, "ageRange": "≥50", "nihssRange": "n/a", "timeWindow": "chronic AF", "keyInclusion": [ "AF with ≥1 stroke risk factor; not VKA candidate" ], "keyExclusion": [] }, "intervention": "Apixaban 5 mg BID", "comparator": "Aspirin 81-324 mg/d", "primaryEndpoint": { "definition": "Stroke or systemic embolism", "timepoint": "~1 y", "result": "Favored apixaban: 1.6%/y vs 3.7%/y", "effectSize": "HR 0.45", "confidenceInterval": "95% CI 0.32 to 0.62", "pValue": "p<0.001" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "Similar", "mortality": "Similar", "other": "Major bleeding similar" }, "imagingCriteria": "", "applicabilityNotes": "AF stroke prevention superiority of apixaban over aspirin in VKA-unsuitable patients. Did NOT enrol ICH survivors — background context, not direct ICH-survivor evidence.", "limitations": "Pre-DOAC adoption era; comparator is aspirin; prior-ICH patients not enrolled.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-averroes-2011" ], "relatedActiveTrialIds": [ "aspire" ], "practiceImpact": "Supports anticoagulation over aspirin for AF stroke prevention generally; the ICH-survivor question is answered by the dedicated trials below.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "artesia", "shortName": "ARTESiA", "fullName": "Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation", "topic": "af-after-ich", "diseaseArea": [ "secondary-prevention", "af-after-ich" ], "population": { "n": 4012, "ageRange": "≥55", "nihssRange": "n/a", "timeWindow": "subclinical AF detected on device", "keyInclusion": [ "Subclinical AF on cardiac implantable device" ], "keyExclusion": [] }, "intervention": "Apixaban", "comparator": "Aspirin 81 mg", "primaryEndpoint": { "definition": "Stroke or systemic embolism", "timepoint": "3.5 y", "result": "Favored apixaban: 0.78%/y vs 1.24%/y", "effectSize": "HR 0.63", "confidenceInterval": "95% CI 0.45 to 0.88", "pValue": "p=0.007" }, "secondaryEndpoints": [ { "name": "Major bleeding", "result": "1.71%/y vs 0.94%/y; HR 1.80" } ], "safetyFindings": { "sich": "Similar", "mortality": "Similar", "other": "Major bleeding higher with apixaban" }, "imagingCriteria": "", "applicabilityNotes": "Subclinical-AF trial illustrating the stroke-vs-bleeding trade-off; it did NOT enrol ICH survivors, so it is background rather than direct evidence for that population.", "limitations": "Subclinical AF only; prior-ICH patients not enrolled.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-artesia-2023" ], "relatedActiveTrialIds": [ "aspire" ], "practiceImpact": "Establishes apixaban benefit in subclinical AF; the ICH-survivor question is addressed by PRESTIGE-AF, SoSTART, APACHE-AF and the COCROACH meta-analysis, which enrolled that population.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "enchanted2-mt", "shortName": "ENCHANTED2/MT", "fullName": "Intensive BP Control after Endovascular Thrombectomy", "topic": "bp-post-evt", "diseaseArea": [ "acute-ischemic-stroke", "bp-post-evt" ], "population": { "n": 821, "ageRange": "≥18", "nihssRange": "all", "timeWindow": "post-successful EVT", "keyInclusion": [ "Successful EVT with mTICI 2b/3" ], "keyExclusion": [] }, "intervention": "Intensive SBP target 120-140 mmHg", "comparator": "Less-intensive SBP target 140-180 mmHg", "primaryEndpoint": { "definition": "mRS shift at 90 d", "timepoint": "90 d", "result": "Favored less-intensive (worse with intensive)", "effectSize": "OR 1.37", "confidenceInterval": "95% CI 1.07 to 1.76", "pValue": "p=0.012" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "Similar", "mortality": "Similar", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Post-EVT BP intensive lowering harmful; conventional control preferred.", "limitations": "Single-region trial (China).", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-enchanted2-mt-2022" ], "relatedActiveTrialIds": [], "practiceImpact": "Avoid intensive BP lowering after successful EVT; target 140-180 mmHg.", "lastReviewed": "2026-04-25", "promotedDate": "2026-04-25", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "optimas", "shortName": "OPTIMAS", "fullName": "Optimal Timing of Anticoagulation after Acute Ischaemic Stroke with Atrial Fibrillation", "topic": "af-anticoag-timing", "diseaseArea": [ "secondary-prevention", "af-anticoag-timing" ], "population": { "n": 3621, "ageRange": "≥18", "nihssRange": "", "timeWindow": "Early ≤4 d vs delayed 7-14 d", "keyInclusion": [ "AF + acute ischaemic stroke" ], "keyExclusion": [] }, "intervention": "Early DOAC (≤4 d)", "comparator": "Delayed DOAC (7-14 d)", "primaryEndpoint": { "definition": "Composite: recurrent ischaemic stroke, sICH, unclassifiable stroke, systemic embolism", "timepoint": "90 d", "result": "Non-inferior: 3.3% vs 3.3%", "effectSize": "Adjusted risk difference 0.000", "confidenceInterval": "95% CI −0.011 to 0.012", "pValue": "p=0.0003 (non-inferiority)" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "Low and similar", "mortality": "", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Enrolled across infarct sizes; supports not delaying initiation.", "limitations": "Open-label timing; blinded endpoint.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-optimas-2024" ], "relatedActiveTrialIds": [], "practiceImpact": "Early DOAC (≤4 d) non-inferior to delayed — do not routinely delay anticoagulation.", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "catalyst", "shortName": "CATALYST", "fullName": "IPD Meta-analysis of Anticoagulation Timing after Ischaemic Stroke with AF", "topic": "af-anticoag-timing", "diseaseArea": [ "secondary-prevention", "af-anticoag-timing" ], "population": { "n": 5441, "ageRange": "", "nihssRange": "", "timeWindow": "Early ≤4 d vs later ≥5 d", "keyInclusion": [ "AF + ischaemic stroke", "Pooled TIMING, ELAN, OPTIMAS, START" ], "keyExclusion": [] }, "intervention": "Early DOAC (≤4 d)", "comparator": "Later DOAC (≥5 d)", "primaryEndpoint": { "definition": "Composite: recurrent ischaemic stroke, sICH, unclassified stroke", "timepoint": "30 d", "result": "Favored early: 2.1% vs 3.0%", "effectSize": "OR 0.70", "confidenceInterval": "95% CI 0.50 to 0.98", "pValue": "p=0.039" }, "secondaryEndpoints": [ { "name": "Recurrent ischaemic stroke", "result": "OR 0.66 (0.45-0.96)" }, { "name": "sICH", "result": "OR 1.02 (0.43-2.46)" } ], "safetyFindings": { "sich": "No excess (OR 1.02)", "mortality": "", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Individual-patient-data pooling of 4 RCTs.", "limitations": "Meta-analysis of open-label-timing trials.", "certainty": "high", "evidenceType": "meta-analysis", "citationIds": [ "cit-catalyst-2025" ], "relatedActiveTrialIds": [], "practiceImpact": "Pooled IPD shows early DOAC (≤4 d) reduces 30-d composite — supports early initiation.", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "navigate-esus", "shortName": "NAVIGATE ESUS", "fullName": "Rivaroxaban for Stroke Prevention after Embolic Stroke of Undetermined Source", "topic": "esus", "diseaseArea": [ "secondary-prevention", "esus" ], "population": { "n": 7213, "ageRange": "≥50", "nihssRange": "", "timeWindow": "", "keyInclusion": [ "ESUS" ], "keyExclusion": [ "Known AF" ] }, "intervention": "Rivaroxaban 15 mg", "comparator": "Aspirin 100 mg", "primaryEndpoint": { "definition": "Recurrent stroke or systemic embolism", "timepoint": "Annualized", "result": "No benefit: 5.1%/yr vs 4.8%/yr", "effectSize": "HR 1.07", "confidenceInterval": "95% CI 0.87 to 1.33", "pValue": "p=0.52" }, "secondaryEndpoints": [ { "name": "Major bleeding", "result": "HR 2.72 (1.68-4.39), p<0.001" } ], "safetyFindings": { "sich": "", "mortality": "Similar", "other": "Major bleeding higher with rivaroxaban" }, "imagingCriteria": "", "applicabilityNotes": "", "limitations": "Stopped early for futility/harm.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-navigate-esus-2018" ], "relatedActiveTrialIds": [], "practiceImpact": "Rivaroxaban not superior to aspirin in ESUS and more bleeding — empiric anticoagulation not indicated.", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "respect-esus", "shortName": "RE-SPECT ESUS", "fullName": "Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source", "topic": "esus", "diseaseArea": [ "secondary-prevention", "esus" ], "population": { "n": 5390, "ageRange": "≥60 (or ≥45 with risk factor)", "nihssRange": "", "timeWindow": "", "keyInclusion": [ "ESUS" ], "keyExclusion": [ "Known AF" ] }, "intervention": "Dabigatran 150/110 mg BID", "comparator": "Aspirin 100 mg", "primaryEndpoint": { "definition": "Recurrent stroke", "timepoint": "Annualized", "result": "No benefit: 4.1%/yr vs 4.8%/yr", "effectSize": "HR 0.85", "confidenceInterval": "95% CI 0.69 to 1.03", "pValue": "p=0.10" }, "secondaryEndpoints": [ { "name": "Major bleeding", "result": "HR 1.19 (0.85-1.66)" } ], "safetyFindings": { "sich": "", "mortality": "Similar", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "", "limitations": "", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-respect-esus-2019" ], "relatedActiveTrialIds": [], "practiceImpact": "Dabigatran not superior to aspirin in ESUS — confirms NAVIGATE; no empiric DOAC.", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "arcadia", "shortName": "ARCADIA", "fullName": "Apixaban to Prevent Recurrence after Cryptogenic Stroke in Patients with Atrial Cardiopathy", "topic": "esus", "diseaseArea": [ "secondary-prevention", "esus" ], "population": { "n": 1015, "ageRange": "≥45", "nihssRange": "", "timeWindow": "", "keyInclusion": [ "Cryptogenic stroke", "Atrial cardiopathy", "No AF" ], "keyExclusion": [ "Known AF" ] }, "intervention": "Apixaban 5 mg BID", "comparator": "Aspirin 81 mg", "primaryEndpoint": { "definition": "Recurrent stroke", "timepoint": "Annualized", "result": "No benefit: 4.4%/yr vs 4.4%/yr", "effectSize": "HR 1.00", "confidenceInterval": "95% CI 0.64 to 1.55", "pValue": "Stopped for futility" }, "secondaryEndpoints": [ { "name": "Symptomatic ICH", "result": "0 (apixaban) vs 7 (aspirin)" } ], "safetyFindings": { "sich": "0 vs 7", "mortality": "", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Atrial cardiopathy: P-wave terminal force, NT-proBNP, or LA diameter.", "limitations": "Stopped for futility.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-arcadia-2024" ], "relatedActiveTrialIds": [], "practiceImpact": "Apixaban no better than aspirin in atrial-cardiopathy ESUS — atrial cardiopathy alone does not justify anticoagulation.", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "laste", "shortName": "LASTE", "fullName": "Thrombectomy for Stroke with a Large Infarct of Unrestricted Size", "topic": "evt-large-core", "diseaseArea": [ "acute-ischemic-stroke", "evt-large-core" ], "population": { "n": 333, "ageRange": "≥18", "nihssRange": "", "timeWindow": "≤6.5 h", "keyInclusion": [ "ASPECTS ≤5", "Large core, unrestricted size" ], "keyExclusion": [] }, "intervention": "EVT + medical care", "comparator": "Medical care", "primaryEndpoint": { "definition": "mRS shift at 90 d", "timepoint": "90 d", "result": "Favored EVT (median mRS 4 vs 6)", "effectSize": "Generalized OR 1.63", "confidenceInterval": "95% CI 1.29 to 2.06", "pValue": "p<0.001" }, "secondaryEndpoints": [ { "name": "90-d mortality", "result": "36.1% vs 55.5% (adj RR 0.65, 0.50-0.84)" } ], "safetyFindings": { "sich": "9.6% vs 5.7%", "mortality": "36.1% vs 55.5%", "other": "" }, "imagingCriteria": "ASPECTS ≤5, no upper infarct-size limit, ≤6.5 h", "applicabilityNotes": "Extends EVT to very large infarcts.", "limitations": "Stopped early; more sICH.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-laste-2024" ], "relatedActiveTrialIds": [], "practiceImpact": "Thrombectomy benefits even very large infarcts (ASPECTS ≤5), at the cost of more sICH.", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "respect-pfo", "shortName": "RESPECT", "fullName": "Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke", "topic": "pfo-closure", "diseaseArea": [ "secondary-prevention", "pfo-closure" ], "population": { "n": 980, "ageRange": "18-60", "nihssRange": "", "timeWindow": "", "keyInclusion": [ "PFO", "Cryptogenic stroke" ], "keyExclusion": [] }, "intervention": "PFO closure (Amplatzer)", "comparator": "Medical therapy", "primaryEndpoint": { "definition": "Recurrent ischaemic stroke (ITT)", "timepoint": "Median 5.9 y", "result": "Favored closure: 0.58 vs 1.07 per 100 pt-yr", "effectSize": "HR 0.55", "confidenceInterval": "95% CI 0.31 to 0.999", "pValue": "p=0.046" }, "secondaryEndpoints": [ { "name": "Stroke of undetermined cause", "result": "HR 0.38 (0.18-0.79), p=0.007" } ], "safetyFindings": { "sich": "", "mortality": "", "other": "Device / AF events" }, "imagingCriteria": "", "applicabilityNotes": "Long-term follow-up of the RESPECT cohort.", "limitations": "", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-respect-pfo-2017" ], "relatedActiveTrialIds": [], "practiceImpact": "Long-term PFO closure reduces recurrent stroke vs medical therapy in selected patients <60 y.", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "close", "shortName": "CLOSE", "fullName": "Patent Foramen Ovale Closure or Anticoagulation vs Antiplatelets after Stroke", "topic": "pfo-closure", "diseaseArea": [ "secondary-prevention", "pfo-closure" ], "population": { "n": 663, "ageRange": "16-60", "nihssRange": "", "timeWindow": "", "keyInclusion": [ "PFO with atrial septal aneurysm or large shunt", "Cryptogenic stroke" ], "keyExclusion": [] }, "intervention": "PFO closure + antiplatelet", "comparator": "Antiplatelet alone", "primaryEndpoint": { "definition": "Recurrent stroke", "timepoint": "Mean 5.3 y", "result": "Favored closure: 0/238 vs 14/235", "effectSize": "HR 0.03", "confidenceInterval": "95% CI 0 to 0.26", "pValue": "p<0.001" }, "secondaryEndpoints": [ { "name": "New-onset AF", "result": "4.6% vs 0.9% (p=0.02)" } ], "safetyFindings": { "sich": "", "mortality": "", "other": "AF higher with closure" }, "imagingCriteria": "Atrial septal aneurysm or large shunt", "applicabilityNotes": "High-risk PFO anatomy.", "limitations": "", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-close-2017" ], "relatedActiveTrialIds": [], "practiceImpact": "Closure markedly cuts recurrent stroke in high-risk PFO anatomy (ASA / large shunt).", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "reduce", "shortName": "REDUCE", "fullName": "Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke", "topic": "pfo-closure", "diseaseArea": [ "secondary-prevention", "pfo-closure" ], "population": { "n": 664, "ageRange": "18-59", "nihssRange": "", "timeWindow": "", "keyInclusion": [ "PFO", "Cryptogenic stroke (81% mod/large shunt)" ], "keyExclusion": [] }, "intervention": "PFO closure + antiplatelet", "comparator": "Antiplatelet alone", "primaryEndpoint": { "definition": "Clinical recurrent ischaemic stroke", "timepoint": "Median 3.2 y", "result": "Favored closure: 1.4% vs 5.4%", "effectSize": "HR 0.23", "confidenceInterval": "95% CI 0.09 to 0.62", "pValue": "p=0.002" }, "secondaryEndpoints": [ { "name": "New brain infarction", "result": "RR 0.51 (0.29-0.91), p=0.04" } ], "safetyFindings": { "sich": "", "mortality": "", "other": "AF / device events higher" }, "imagingCriteria": "", "applicabilityNotes": "", "limitations": "", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-reduce-2017" ], "relatedActiveTrialIds": [], "practiceImpact": "Closure reduces recurrent stroke and new infarcts; watch for AF and device events.", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "interact2", "shortName": "INTERACT2", "fullName": "Rapid Blood-Pressure Lowering in Acute Intracerebral Hemorrhage", "topic": "ich-bp-management", "diseaseArea": [ "ich", "ich-bp-management" ], "population": { "n": 2839, "ageRange": "≥18", "nihssRange": "", "timeWindow": "≤6 h", "keyInclusion": [ "Spontaneous ICH", "SBP 150-220" ], "keyExclusion": [] }, "intervention": "Intensive SBP <140 within 1 h", "comparator": "Guideline SBP <180", "primaryEndpoint": { "definition": "Death or major disability (mRS 3-6)", "timepoint": "90 d", "result": "Negative primary: 52.0% vs 55.6%", "effectSize": "OR 0.87", "confidenceInterval": "95% CI 0.75 to 1.01", "pValue": "p=0.06" }, "secondaryEndpoints": [ { "name": "Ordinal mRS shift", "result": "OR 0.87 (0.77-1.00), p=0.04" } ], "safetyFindings": { "sich": "", "mortality": "Similar", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "", "limitations": "Dichotomous primary not met; ordinal analysis favored intensive lowering.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-interact2-2013" ], "relatedActiveTrialIds": [], "practiceImpact": "Supports early BP reduction in ICH; ordinal benefit despite a negative dichotomous primary.", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "atach-2", "shortName": "ATACH-2", "fullName": "Intensive Blood-Pressure Lowering in Acute Cerebral Hemorrhage", "topic": "ich-bp-management", "diseaseArea": [ "ich", "ich-bp-management" ], "population": { "n": 1000, "ageRange": "≥18", "nihssRange": "", "timeWindow": "≤4.5 h", "keyInclusion": [ "ICH <60 cm³", "GCS ≥5" ], "keyExclusion": [] }, "intervention": "Intensive SBP 110-139 (nicardipine)", "comparator": "Standard SBP 140-179", "primaryEndpoint": { "definition": "Death or disability (mRS 4-6)", "timepoint": "3 mo", "result": "No benefit: 38.7% vs 37.7%", "effectSize": "RR 1.04", "confidenceInterval": "95% CI 0.85 to 1.27", "pValue": "Stopped for futility" }, "secondaryEndpoints": [ { "name": "Renal adverse events", "result": "9.0% vs 4.0% (p=0.002)" } ], "safetyFindings": { "sich": "", "mortality": "Similar", "other": "More renal AEs with intensive target" }, "imagingCriteria": "", "applicabilityNotes": "Argues against targeting <140 vs ~140.", "limitations": "Stopped for futility.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-atach2-2016" ], "relatedActiveTrialIds": [], "practiceImpact": "More intensive target (<140) gave no benefit and more renal AEs — avoid overshoot below ~140.", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "mistie-iii", "shortName": "MISTIE III", "fullName": "Minimally Invasive Surgery with Thrombolysis in ICH Evacuation", "topic": "ich-surgery", "diseaseArea": [ "ich", "ich-surgery" ], "population": { "n": 506, "ageRange": "≥18", "nihssRange": "", "timeWindow": "", "keyInclusion": [ "Supratentorial ICH ≥30 mL" ], "keyExclusion": [] }, "intervention": "MIS catheter + alteplase", "comparator": "Standard medical care", "primaryEndpoint": { "definition": "Good outcome (mRS 0-3)", "timepoint": "365 d", "result": "Negative: 45% vs 41%", "effectSize": "Adjusted risk difference 4%", "confidenceInterval": "95% CI −4% to 12%", "pValue": "p=0.33" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "", "mortality": "Lower with MIS (secondary)", "other": "Outcome better when residual clot ≤15 mL" }, "imagingCriteria": "", "applicabilityNotes": "Functional outcome tied to extent of clot evacuation.", "limitations": "Negative primary; benefit signal only with adequate evacuation.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-mistie3-2019" ], "relatedActiveTrialIds": [], "practiceImpact": "No overall functional benefit; safe; outcome depends on achieving adequate evacuation.", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "crest", "shortName": "CREST", "fullName": "Stenting versus Endarterectomy for Carotid-Artery Stenosis", "topic": "carotid-revasc", "diseaseArea": [ "secondary-prevention", "carotid-revasc" ], "population": { "n": 2502, "ageRange": "", "nihssRange": "", "timeWindow": "", "keyInclusion": [ "Symptomatic or asymptomatic carotid stenosis" ], "keyExclusion": [] }, "intervention": "Carotid artery stenting (CAS)", "comparator": "Carotid endarterectomy (CEA)", "primaryEndpoint": { "definition": "Composite periprocedural stroke/MI/death or 4-y ipsilateral stroke", "timepoint": "4 y", "result": "Equivalent: 7.2% vs 6.8%", "effectSize": "HR 1.11", "confidenceInterval": "95% CI 0.81 to 1.51", "pValue": "p=0.51" }, "secondaryEndpoints": [ { "name": "Periprocedural stroke", "result": "CAS 4.1% vs CEA 2.3% (p=0.01)" }, { "name": "Periprocedural MI", "result": "CAS 1.1% vs CEA 2.3% (p=0.03)" } ], "safetyFindings": { "sich": "", "mortality": "Similar", "other": "Stroke favors CEA; MI favors CAS" }, "imagingCriteria": "", "applicabilityNotes": "Age interaction: CAS worse periprocedural stroke in older patients.", "limitations": "", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-crest-2010" ], "relatedActiveTrialIds": [], "practiceImpact": "CAS and CEA equivalent on the composite; stroke risk favors CEA, MI risk favors CAS.", "lastReviewed": "2026-05-29", "promotedDate": "2026-05-29", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "oceanic-stroke", "shortName": "OCEANIC-STROKE", "fullName": "Asundexian for Secondary Stroke Prevention", "topic": "secondary-prevention", "diseaseArea": [ "secondary-prevention" ], "population": { "n": 12327, "ageRange": "≥18", "nihssRange": "", "timeWindow": "≤72 h", "keyInclusion": [ "Noncardioembolic ischaemic stroke or high-risk TIA", "Atherosclerosis / nonlacunar infarct / atherosclerotic plaque" ], "keyExclusion": [] }, "intervention": "Asundexian 50 mg once daily + antiplatelet therapy", "comparator": "Placebo + antiplatelet therapy", "primaryEndpoint": { "definition": "Ischaemic stroke", "timepoint": "Trial duration", "result": "Lower with asundexian: 6.2% vs 8.4%", "effectSize": "Cause-specific HR 0.74", "confidenceInterval": "95% CI 0.65 to 0.84", "pValue": "p<0.001" }, "secondaryEndpoints": [ { "name": "CV death, MI, or stroke", "result": "Lower with asundexian" }, { "name": "Major bleeding", "result": "1.9% vs 1.7% (HR 1.10, 0.85-1.44)" } ], "safetyFindings": { "sich": "", "mortality": "", "other": "Major bleeding similar (HR 1.10, 0.85-1.44)" }, "imagingCriteria": "", "applicabilityNotes": "First positive phase-3 factor XIa inhibitor for secondary prevention.", "limitations": "On-top-of-antiplatelet design; long-term safety still accruing.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-oceanic-stroke-2026" ], "relatedActiveTrialIds": [], "practiceImpact": "Asundexian on top of antiplatelets cut ischaemic stroke ~26% without more major bleeding — could reshape noncardioembolic prevention.", "lastReviewed": "2026-05-30", "promotedDate": "2026-05-30", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "trident", "shortName": "TRIDENT", "fullName": "Three Low-Dose Antihypertensive Agents in a Single Pill after Intracerebral Hemorrhage", "topic": "ich-secondary-prevention", "diseaseArea": [ "ich", "secondary-prevention", "ich-secondary-prevention" ], "population": { "n": 1670, "ageRange": "Mean 58", "nihssRange": "", "timeWindow": "", "keyInclusion": [ "History of intracerebral haemorrhage", "Baseline SBP 130-160 mm Hg", "Clinically stable" ], "keyExclusion": [] }, "intervention": "Single-pill triple therapy: telmisartan 20 mg / amlodipine 2.5 mg / indapamide 1.25 mg + standard care", "comparator": "Placebo + standard care", "primaryEndpoint": { "definition": "First recurrent stroke", "timepoint": "Median 2.5 y", "result": "Lower with triple pill: 4.6% vs 7.4%", "effectSize": "HR 0.61", "confidenceInterval": "95% CI 0.41 to 0.92", "pValue": "p=0.02" }, "secondaryEndpoints": [ { "name": "Major cardiovascular events", "result": "6.6% vs 9.8% (p=0.04)" }, { "name": "Mean SBP on follow-up", "result": "127 vs 138 mm Hg" } ], "safetyFindings": { "sich": "", "mortality": "", "other": "Early discontinuation 13.6% vs 6.0%, mainly ≥20% serum creatinine rise" }, "imagingCriteria": "", "applicabilityNotes": "Simplified low-dose triple pill after ICH; 2-week active run-in before randomisation.", "limitations": "Higher adverse-event discontinuation with triple pill.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-trident-2026" ], "relatedActiveTrialIds": [], "practiceImpact": "A simplified low-dose triple pill after ICH lowers recurrent stroke and CV events — supports intensive, simplified BP-lowering.", "lastReviewed": "2026-05-30", "promotedDate": "2026-05-30", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "atlas", "shortName": "ATLAS", "fullName": "Endovascular Thrombectomy for Large-Core Ischaemic Stroke up to 24 h — Systematic Review and IPD Meta-analysis with Central Imaging Adjudication", "topic": "evt-large-core", "diseaseArea": [ "acute-ischemic-stroke", "evt-large-core" ], "population": { "n": 1886, "ageRange": "", "nihssRange": "", "timeWindow": "≤24 h", "keyInclusion": [ "ASPECTS ≤5 or estimated ischaemic core ≥50 mL", "6 randomised trials" ], "keyExclusion": [] }, "intervention": "Endovascular thrombectomy", "comparator": "Medical management", "primaryEndpoint": { "definition": "90-day mRS distribution (ordinal shift)", "timepoint": "90 d", "result": "Favored EVT (median mRS 4 vs 5)", "effectSize": "Adjusted pooled generalised OR 1.63", "confidenceInterval": "95% CI 1.42 to 1.88", "pValue": "p<0.0001" }, "secondaryEndpoints": [ { "name": "90-day mortality", "result": "31.1% vs 37.3% (aRR 0.82, 0.70-0.97)" }, { "name": "Symptomatic ICH within 36 h", "result": "1.1% vs 1.0% (RD -0.17 pp, -1.01 to 0.67)" } ], "safetyFindings": { "sich": "1.1% vs 1.0%", "mortality": "31.1% vs 37.3%", "other": "" }, "imagingCriteria": "ASPECTS ≤5 or core ≥50 mL; central imaging core-lab readjudication", "applicabilityNotes": "Benefit sustained across ASPECTS / core strata to 24 h; uncertain for core ≥150 mL beyond 6 h.", "limitations": "Wide CIs for very extensive cores (≥150 mL); trial-level heterogeneity.", "certainty": "high", "evidenceType": "meta-analysis", "citationIds": [ "cit-atlas-2026" ], "relatedActiveTrialIds": [], "practiceImpact": "Consolidates EVT benefit across large-core strata to 24 h, except very extensive cores (≥150 mL) beyond 6 h where evidence remains limited.", "lastReviewed": "2026-05-30", "promotedDate": "2026-05-30", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "tapis", "shortName": "TAPIS", "fullName": "Ticagrelor with Aspirin Dual Antiplatelet Therapy combined with Intravenous Thrombolysis in Patients with Ischaemic Stroke in China", "topic": "dapt-minor-stroke", "diseaseArea": [ "acute-ischemic-stroke", "dapt-minor-stroke" ], "population": { "n": 1382, "ageRange": "Median 65.6", "nihssRange": "4-10", "timeWindow": "≤6 h of onset", "keyInclusion": [ "Treated with IV thrombolysis", "NIHSS 4-10" ], "keyExclusion": [] }, "intervention": "Oral aspirin + ticagrelor DAPT within 6 h (ticagrelor days 2-7)", "comparator": "Placebo (open-label aspirin days 2-90)", "primaryEndpoint": { "definition": "Excellent functional outcome (mRS 0-1)", "timepoint": "90 d", "result": "Higher with early DAPT: 68.7% vs 62.0%", "effectSize": "Risk ratio 1.11", "confidenceInterval": "95% CI 1.03 to 1.20", "pValue": "p=0.0089" }, "secondaryEndpoints": [ { "name": "Symptomatic ICH within 36 h", "result": "0.9% vs 0.7% (RR 1.20, 0.37-3.93)" } ], "safetyFindings": { "sich": "0.9% vs 0.7%", "mortality": "", "other": "Wide CIs preclude excluding a small sICH increase" }, "imagingCriteria": "", "applicabilityNotes": "Early oral DAPT as an adjunct to thrombolysis in moderate stroke; single-country (China) trial.", "limitations": "Open-label aspirin days 2-90; sICH CIs wide.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-tapis-2026" ], "relatedActiveTrialIds": [], "practiceImpact": "Early oral DAPT within 6 h as an adjunct to thrombolysis improved excellent outcomes in moderate stroke — a strategy long considered contraindicated; small sICH risk not excluded.", "lastReviewed": "2026-05-30", "promotedDate": "2026-05-30", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "choice-2", "shortName": "CHOICE-2", "fullName": "Adjunctive Intra-Arterial Alteplase After Successful Thrombectomy for Acute Ischemic Stroke", "topic": "ia-adjunct-after-evt", "diseaseArea": [ "acute-ischemic-stroke", "ia-adjunct-after-evt" ], "population": { "n": 433, "ageRange": "Median 76", "nihssRange": "", "timeWindow": "≤24 h", "keyInclusion": [ "LVO treated with thrombectomy", "eTICI 2b50-3 after EVT" ], "keyExclusion": [] }, "intervention": "Thrombectomy + intra-arterial alteplase 0.225 mg/kg (max 20 mg) over 15 min", "comparator": "Thrombectomy alone", "primaryEndpoint": { "definition": "Excellent functional outcome (mRS 0-1)", "timepoint": "90 d", "result": "Higher with IA alteplase: 57.5% vs 42.5%", "effectSize": "Adjusted risk difference 15.0%", "confidenceInterval": "95% CI 5.7% to 24.3%", "pValue": "p=0.002" }, "secondaryEndpoints": [ { "name": "90-day mortality", "result": "12.1% vs 6.4% (adj RD 5.9%, 0.5-11.3; p=0.03)" }, { "name": "Residual hypoperfusion", "result": "28.6% vs 50.5% (adj RD -22.0%, -31.5 to -12.4)" } ], "safetyFindings": { "sich": "1.4% vs 0.5% (aOR 3.10, 0.32-30.0)", "mortality": "12.1% vs 6.4%", "other": "Higher mortality signal warrants caution" }, "imagingCriteria": "eTICI 2b50-3 after successful thrombectomy", "applicabilityNotes": "Open-label trial, blinded outcome; 14 centres in Spain.", "limitations": "Higher mortality with IA alteplase; modest sample.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-choice-2-2026" ], "relatedActiveTrialIds": [], "practiceImpact": "IA alteplase after successful EVT improved excellent outcomes and reperfusion — but a higher mortality signal warrants caution before adoption.", "lastReviewed": "2026-05-30", "promotedDate": "2026-05-30", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "distal", "shortName": "DISTAL", "fullName": "Endovascular Treatment for Medium or Distal Vessel Occlusion Stroke — 12-Month Outcomes", "topic": "evt-mevo", "diseaseArea": [ "acute-ischemic-stroke", "evt-mevo" ], "population": { "n": 543, "ageRange": "Median 77", "nihssRange": "Median 6", "timeWindow": "≤6 h, or 6-24 h with salvageable tissue", "keyInclusion": [ "Medium/distal occlusion: M2/M3-M4, A1-A3, P1-P3" ], "keyExclusion": [] }, "intervention": "Endovascular treatment + best medical treatment", "comparator": "Best medical treatment alone", "primaryEndpoint": { "definition": "Disability on ordinal mRS (scores 5-6 combined)", "timepoint": "12 mo", "result": "No difference (median mRS 2 vs 2)", "effectSize": "Adjusted common OR 0.81", "confidenceInterval": "95% CI 0.59 to 1.12", "pValue": "p=0.20" }, "secondaryEndpoints": [ { "name": "Overall survival", "result": "HR 1.46 (0.93-2.30), p=0.10" } ], "safetyFindings": { "sich": "", "mortality": "Survival similar (HR 1.46, NS)", "other": "" }, "imagingCriteria": "Salvageable tissue required for 6-24 h window", "applicabilityNotes": "12-month results consistent with 90-day results; mild-to-moderate MeVO.", "limitations": "Open-label; benefit not excluded in subgroups.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-distal-2025", "cit-distal-2026" ], "relatedActiveTrialIds": [ "step-evt" ], "practiceImpact": "No long-term benefit of EVT in mild-to-moderate medium/distal vessel occlusion — routine thrombectomy not supported in this population.", "lastReviewed": "2026-05-30", "promotedDate": "2026-05-30", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "escape-mevo", "shortName": "ESCAPE-MeVO", "fullName": "Endovascular Treatment for Medium Vessel Occlusion Stroke", "topic": "evt-mevo", "diseaseArea": [ "acute-ischemic-stroke", "evt-mevo" ], "population": { "n": 530, "ageRange": "Mean 69.8", "nihssRange": "Median 8", "timeWindow": "≤24 h (median 4.6 h)", "keyInclusion": [ "Medium vessel occlusion (M2/M3 branches of MCA, A2/A3 branches of ACA, P2/P3 branches of PCA)", "NIHSS ≥5 or disabling NIHSS 2-4", "ASPECTS ≥5 on CT (or ≥6 on MRI)" ], "keyExclusion": [] }, "intervention": "Endovascular treatment + best medical management", "comparator": "Best medical management alone", "primaryEndpoint": { "definition": "Disability on ordinal mRS", "timepoint": "90 d", "result": "No difference (adjusted common OR 0.90)", "effectSize": "Adjusted common OR 0.90", "confidenceInterval": "95% CI 0.68 to 1.18", "pValue": "p=0.45" }, "secondaryEndpoints": [ { "name": "mRS 0-1 at 90 d", "result": "47.5% vs 46.2% (aOR 0.99, 95% CI 0.69 to 1.43)" }, { "name": "mRS 0-2 at 90 d", "result": "60.3% vs 60.1% (aOR 0.98, 95% CI 0.67 to 1.43)" } ], "safetyFindings": { "sich": "5.4% vs 2.2% (aOR 2.37, 95% CI 0.90 to 6.27)", "mortality": "13.3% vs 8.4% (aHR 1.82, 95% CI 1.06 to 3.12)", "other": "Higher 90-day mortality in the EVT group (safety signal)" }, "imagingCriteria": "CTA/MRA-selected MeVO", "applicabilityNotes": "No functional benefit and showed a signal of increased 90-day mortality and sICH.", "limitations": "Open-label trial; ended early for enrollment feasibility.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-escape-mevo-2025" ], "relatedActiveTrialIds": [ "step-evt" ], "practiceImpact": "Does not support routine endovascular thrombectomy for isolated medium vessel occlusion stroke outside of clinical trials.", "lastReviewed": "2026-05-30", "promotedDate": "2026-05-30", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "direct-angio", "shortName": "DIRECT ANGIO", "fullName": "Direct versus Conventional Transfer to Angiography Suite in Patients with Severe Acute Stroke Treated with Thrombectomy (France)", "topic": "acute-ischemic-stroke", "diseaseArea": [ "acute-ischemic-stroke" ], "population": { "n": 115, "ageRange": "≤85", "nihssRange": "", "timeWindow": "≤5 h of onset", "keyInclusion": [ "Acute severe neurological deficit highly suggestive of LVO (ASND-LVO)" ], "keyExclusion": [] }, "intervention": "Direct transfer to angiography suite (DTAS)", "comparator": "Conventional imaging-first pathway", "primaryEndpoint": { "definition": "Functional independence (mRS 0-2)", "timepoint": "90 d", "result": "No benefit: 36% vs 42%", "effectSize": "Adjusted OR 0.73", "confidenceInterval": "95% CI 0.32 to 1.69", "pValue": "" }, "secondaryEndpoints": [ { "name": "Symptomatic ICH", "result": "15% vs 0% (adj OR 11.0, 1.28-1406)" }, { "name": "All-cause mortality", "result": "18% vs 11% (adj OR 1.65, 0.52-5.55)" } ], "safetyFindings": { "sich": "15% vs 0% (adj OR 11.0)", "mortality": "18% vs 11% (NS)", "other": "Trial stopped early for safety" }, "imagingCriteria": "", "applicabilityNotes": "Stopped early for safety after interim analysis; 10 comprehensive stroke centres.", "limitations": "Small n (115) limits precision of all estimates.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-direct-angio-2026" ], "relatedActiveTrialIds": [], "practiceImpact": "Bypassing pre-EVT imaging increased sICH without benefit and was halted early — cautions against direct-to-angio in suspected LVO.", "lastReviewed": "2026-05-30", "promotedDate": "2026-05-30", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "stabled", "shortName": "STABLED", "fullName": "Catheter Ablation and Oral Anticoagulation for Secondary Stroke Prevention in Atrial Fibrillation", "topic": "af-anticoag-timing", "diseaseArea": [ "secondary-prevention", "af-anticoag-timing" ], "population": { "n": 249, "ageRange": "20-85 (mean 71.7)", "nihssRange": "", "timeWindow": "Ablation 1-6 mo after index stroke", "keyInclusion": [ "Nonvalvular AF", "Prior ischaemic stroke", "On / scheduled for edoxaban", "mRS ≤3" ], "keyExclusion": [] }, "intervention": "Standard therapy + catheter ablation", "comparator": "Standard therapy (edoxaban) alone", "primaryEndpoint": { "definition": "Composite: recurrent ischaemic stroke, systemic embolism, all-cause death, HF hospitalisation", "timepoint": "Median >3 y", "result": "No reduction: 5.6% vs 4.9% per person-year", "effectSize": "HR 1.11", "confidenceInterval": "95% CI 0.62 to 2.01", "pValue": "" }, "secondaryEndpoints": [ { "name": "Mortality", "result": "2.8 vs 1.0 per 100 person-years" } ], "safetyFindings": { "sich": "", "mortality": "2.8 vs 1.0 per 100 person-years", "other": "2 ablation-related SAEs (cardiac tamponade, stroke; 0.8% each)" }, "imagingCriteria": "", "applicabilityNotes": "Open-label; 45 sites in Japan; lower-than-anticipated event rate.", "limitations": "Underpowered (low event rate); open-label.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-stabled-2026" ], "relatedActiveTrialIds": [], "practiceImpact": "Adding ablation to anticoagulation did not reduce recurrent events in post-stroke AF (underpowered) — does not support routine ablation for secondary prevention.", "lastReviewed": "2026-05-30", "promotedDate": "2026-05-30", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "suicide-after-stroke", "shortName": "Suicide after stroke", "fullName": "Increased Risk of Suicide after Stroke: A Population-Based Matched Cohort Study", "topic": "special-populations", "diseaseArea": [ "secondary-prevention", "special-populations" ], "population": { "n": 129438, "ageRange": "Mean 71.4", "nihssRange": "", "timeWindow": "2008-2017", "keyInclusion": [ "64,719 stroke patients matched 1:1 to Ontario population controls" ], "keyExclusion": [] }, "intervention": "Hospitalisation for stroke (exposure)", "comparator": "Matched general-population controls", "primaryEndpoint": { "definition": "Suicide (composite of deliberate self-harm or death by suicide)", "timepoint": "Through follow-up (627,774 person-years)", "result": "Higher in stroke survivors: 11.1 vs 3.2 per 10,000 person-years", "effectSize": "HR 2.87", "confidenceInterval": "95% CI 2.35 to 3.51", "pValue": "" }, "secondaryEndpoints": [ { "name": "Younger survivors", "result": "HR 4.34 (2.48-7.61)" }, { "name": "Low-income neighbourhood", "result": "HR 1.88 (1.30-2.70)" }, { "name": "Timing", "result": "67.4% of events after first year" } ], "safetyFindings": { "sich": "", "mortality": "", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Association did not vary by presence of major depression.", "limitations": "Observational — residual confounding; administrative-data ascertainment; association not causation.", "certainty": "moderate", "evidenceType": "observational", "citationIds": [ "cit-suicide-after-stroke-2025" ], "relatedActiveTrialIds": [], "practiceImpact": "Supports long-term (beyond 1 year) suicidality screening in survivors — especially younger and lower-income patients.", "lastReviewed": "2026-05-30", "promotedDate": "2026-05-30", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "hyponatremia-ich", "shortName": "Hyponatremia & ICH", "fullName": "Severity-Stratified Hyponatremia Is Associated with Increased Mortality and Complications in Nontraumatic Intracerebral Hemorrhage", "topic": "ich", "diseaseArea": [ "ich" ], "population": { "n": 45114, "ageRange": "", "nihssRange": "", "timeWindow": "Serum Na ≤7 d of diagnosis", "keyInclusion": [ "Nontraumatic ICH", "Propensity-matched: moderate hypoNa 17,547/arm; severe 5,010/arm", "TriNetX federated EHR" ], "keyExclusion": [] }, "intervention": "Hyponatremia (moderate or severe) within 7 days", "comparator": "Propensity-matched normonatraemia", "primaryEndpoint": { "definition": "30-day mortality", "timepoint": "30 d", "result": "Moderate 17.5% vs 13.3%; severe 18.7% vs 12.9%", "effectSize": "Moderate HR 1.324; severe HR 1.473", "confidenceInterval": "Moderate 95% CI 1.255-1.398; severe 1.332-1.628", "pValue": "p<0.001" }, "secondaryEndpoints": [ { "name": "Complications", "result": "More seizures, cerebral edema, hydrocephalus, EVD, tracheostomy, PEG, DVT, MI" } ], "safetyFindings": { "sich": "", "mortality": "Moderate HR 1.32; severe HR 1.47", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Serum sodium as a readily-available risk-stratification marker in acute ICH.", "limitations": "RWE — coding granularity; illness-severity confounding; whether correcting Na changes outcome is unproven.", "certainty": "low", "evidenceType": "observational", "citationIds": [ "cit-hyponatremia-ich-2026" ], "relatedActiveTrialIds": [], "practiceImpact": "Serum sodium is a readily-available risk-stratification marker in acute ICH; supports vigilant Na monitoring (causality not established).", "lastReviewed": "2026-05-30", "promotedDate": "2026-05-30", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "tnk-vs-alteplase-rwe", "shortName": "TNK vs alteplase · RWE", "fullName": "Real-World Efficacy and Safety of Tenecteplase versus Alteplase in Acute Ischemic Stroke: A Propensity Score-Matched Analysis", "topic": "tnk-vs-alteplase", "diseaseArea": [ "acute-ischemic-stroke", "tnk-vs-alteplase" ], "population": { "n": 371, "ageRange": "", "nihssRange": "", "timeWindow": "", "keyInclusion": [ "Thrombolysed AIS", "68 (18.3%) received tenecteplase", "Single-centre retrospective, propensity-matched" ], "keyExclusion": [] }, "intervention": "Tenecteplase", "comparator": "Alteplase", "primaryEndpoint": { "definition": "Functional independence (mRS 0-2)", "timepoint": "90 d", "result": "Comparable (p>0.05)", "effectSize": "", "confidenceInterval": "", "pValue": "p>0.05 (NS)" }, "secondaryEndpoints": [ { "name": "Symptomatic ICH", "result": "Numerically higher with TNK, NS (p=0.449)" }, { "name": "Door-to-needle time", "result": "Similar between groups" } ], "safetyFindings": { "sich": "Numerically higher with TNK, NS", "mortality": "", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Real-world support for tenecteplase as a practical alteplase alternative.", "limitations": "Small single-centre; no point estimate / CI reported; underpowered for sICH; selection bias.", "certainty": "low", "evidenceType": "observational", "citationIds": [ "cit-tnk-vs-alteplase-rwe-2026" ], "relatedActiveTrialIds": [], "practiceImpact": "Adds real-world support for tenecteplase as a practical alteplase alternative — consistent with trial-level non-inferiority.", "lastReviewed": "2026-05-30", "promotedDate": "2026-05-30", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "bridge-tnk", "shortName": "BRIDGE-TNK", "fullName": "Intravenous Tenecteplase before Thrombectomy in Stroke", "topic": "tnk-vs-alteplase", "diseaseArea": [ "acute-ischemic-stroke", "tnk-vs-alteplase" ], "population": { "n": 550, "ageRange": "adults", "nihssRange": "", "timeWindow": "≤4.5 h", "keyInclusion": [ "Large-vessel occlusion within 4.5 h of onset", "Eligible for IV thrombolysis and for thrombectomy" ], "keyExclusion": [ "Contraindication to IV thrombolysis" ] }, "intervention": "IV tenecteplase 0.25 mg/kg (max 25 mg) then endovascular thrombectomy", "comparator": "Endovascular thrombectomy alone", "primaryEndpoint": { "definition": "Functional independence (mRS 0-2)", "timepoint": "90 d", "result": "Favored TNK + thrombectomy: 52.9% vs 44.1%", "effectSize": "Unadjusted RR 1.20", "confidenceInterval": "95% CI 1.01 to 1.43", "pValue": "p=0.04" }, "secondaryEndpoints": [ { "name": "Successful reperfusion before thrombectomy", "result": "6.1% (TNK) vs 1.1% (thrombectomy alone)" } ], "safetyFindings": { "sich": "8.5% (TNK) vs 6.7% (thrombectomy alone)", "mortality": "22.3% vs 19.9% at 90 d", "other": "" }, "imagingCriteria": "NCCT + CTA; large-vessel occlusion confirmed", "applicabilityNotes": "Supports giving IV tenecteplase before thrombectomy (rather than bypassing thrombolysis) in thrombolysis-eligible LVO presenting within 4.5 h. Does not address bridging in later windows.", "limitations": "Open-label; single-country (China); generalizability to other populations and EVT-access settings uncertain.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-bridge-tnk-2025" ], "relatedActiveTrialIds": [], "practiceImpact": "Reinforces bridging IV thrombolysis before thrombectomy for eligible LVO within 4.5 h; do not routinely skip IVT in eligible patients headed to EVT.", "lastReviewed": "2026-07-06", "promotedDate": "2026-07-06", "verificationStatus": "verified-pubmed", "verificationNotes": "PubMed 40396577; NCT04733742. Primary numbers from published abstract, verified 2026-07-06." }, { "id": "hope-2025", "shortName": "HOPE", "fullName": "Alteplase for Acute Ischemic Stroke at 4.5 to 24 Hours: The HOPE Randomized Clinical Trial", "topic": "extended-window-ivt", "diseaseArea": [ "acute-ischemic-stroke", "extended-window-ivt" ], "population": { "n": 372, "ageRange": "median 72", "nihssRange": "", "timeWindow": "4.5-24 h", "keyInclusion": [ "Salvageable tissue on perfusion imaging", "No initial plan for thrombectomy", "LVO and non-LVO included" ], "keyExclusion": [ "Planned thrombectomy" ] }, "intervention": "IV alteplase 0.9 mg/kg (max 90 mg)", "comparator": "Standard medical treatment", "primaryEndpoint": { "definition": "Functional independence (mRS 0-1)", "timepoint": "90 d", "result": "Favored alteplase: 40% vs 26%", "effectSize": "Adjusted RR 1.52", "confidenceInterval": "95% CI 1.14 to 2.02", "pValue": "p=0.004" }, "secondaryEndpoints": [ { "name": "Symptomatic ICH (36 h)", "result": "3.8% (alteplase) vs 0.51% (control); adjusted RR 7.34" }, { "name": "Mortality (90 d)", "result": "11% in both groups" } ], "safetyFindings": { "sich": "3.8% vs 0.51%", "mortality": "11% vs 11%", "other": "" }, "imagingCriteria": "CT perfusion — salvageable tissue / target mismatch", "applicabilityNotes": "Late-window (4.5-24 h) IV alteplase in perfusion-selected patients not going to thrombectomy. Emerging evidence; not a standard AHA/ASA recommendation. China-only, open-label with blinded endpoint.", "limitations": "Single-country (China); higher sICH; extended-window IVT selection criteria still being defined; do not phrase as routine thrombolysis to 24 h.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-hope-2025" ], "relatedActiveTrialIds": [], "practiceImpact": "Adds positive evidence for perfusion-selected late-window IV thrombolysis in EVT-ineligible patients; remains selective and consult-dependent, not routine.", "lastReviewed": "2026-07-06", "promotedDate": "2026-07-06", "verificationStatus": "verified-pubmed", "verificationNotes": "PubMed 40773205; NCT04879615. Verified 2026-07-06." }, { "id": "expects-2025", "shortName": "EXPECTS", "fullName": "Alteplase for Posterior Circulation Ischemic Stroke at 4.5 to 24 Hours", "topic": "extended-window-ivt", "diseaseArea": [ "acute-ischemic-stroke", "extended-window-ivt" ], "population": { "n": 234, "ageRange": "adults", "nihssRange": "median 3 (mainly mild)", "timeWindow": "4.5-24 h", "keyInclusion": [ "Posterior circulation ischemic stroke", "No extensive early hypodensity on CT", "No planned thrombectomy" ], "keyExclusion": [ "Planned thrombectomy" ] }, "intervention": "IV alteplase 0.9 mg/kg (max 90 mg)", "comparator": "Standard medical treatment", "primaryEndpoint": { "definition": "Functional independence (mRS 0-2)", "timepoint": "90 d", "result": "Favored alteplase: 89.6% vs 72.6%", "effectSize": "Adjusted RR 1.16", "confidenceInterval": "95% CI 1.03 to 1.30", "pValue": "p=0.01" }, "secondaryEndpoints": [ { "name": "Symptomatic ICH (36 h)", "result": "1.7% (alteplase) vs 0.9% (control)" }, { "name": "Mortality (90 d)", "result": "5.2% vs 8.5%" } ], "safetyFindings": { "sich": "1.7% vs 0.9%", "mortality": "5.2% vs 8.5%", "other": "" }, "imagingCriteria": "NCCT (no extensive early hypodensity); no perfusion required", "applicabilityNotes": "Late-window (4.5-24 h) IV alteplase for mainly mild posterior-circulation stroke not going to thrombectomy. Emerging evidence; not a standard AHA/ASA recommendation. China-only; mostly low NIHSS.", "limitations": "Single-country (China); mild strokes predominate; benefit in severe posterior-circulation stroke not established.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-expects-2025" ], "relatedActiveTrialIds": [], "practiceImpact": "Supports late-window thrombolysis for selected mild posterior-circulation stroke without perfusion mismatch requirement; remains emerging, not routine.", "lastReviewed": "2026-07-06", "promotedDate": "2026-07-06", "verificationStatus": "verified-pubmed", "verificationNotes": "PubMed 40174223; NCT05429476. Verified 2026-07-06." }, { "id": "mind-2025", "shortName": "MIND", "fullName": "Minimally Invasive Surgery vs Medical Management Alone for Intracerebral Hemorrhage: The MIND Randomized Clinical Trial", "topic": "ich-surgery", "diseaseArea": [ "ich", "ich-surgery" ], "population": { "n": 236, "ageRange": "18-80", "nihssRange": "≥6", "timeWindow": "≤72 h (surgery)", "keyInclusion": [ "Spontaneous supratentorial ICH 20-80 mL", "NIHSS ≥6", "GCS 5-15" ], "keyExclusion": [ "Underlying vascular lesion" ] }, "intervention": "Minimally invasive surgery (Artemis device) + medical management", "comparator": "Guideline-based medical management alone", "primaryEndpoint": { "definition": "Combined death & disability (ordinal mRS)", "timepoint": "180 d", "result": "No significant benefit of surgery", "effectSize": "OR 1.03", "confidenceInterval": "96% CI 0.62 to 1.72", "pValue": "p=0.45" }, "secondaryEndpoints": [ { "name": "30-day mortality", "result": "7.2% (surgery) vs 9.8% (medical)" } ], "safetyFindings": { "sich": "", "mortality": "7.2% vs 9.8% at 30 d", "other": "Enrollment stopped early (n=236) after a contemporaneous positive ICH trial" }, "imagingCriteria": "CT — supratentorial ICH 20-80 mL", "applicabilityNotes": "MIS with the Artemis device did NOT improve 180-day outcome or reduce 30-day mortality vs medical management. Contrast with ENRICH (positive for a defined lobar-ICH pathway). Early stop limits power.", "limitations": "Stopped early; underpowered; device- and protocol-specific. A negative result — does not support routine MIS outside a defined pathway.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-mind-2025" ], "relatedActiveTrialIds": [], "practiceImpact": "Tempers enthusiasm for minimally invasive ICH evacuation; MIS benefit appears pathway- and technique-specific (cf. ENRICH), not universal.", "lastReviewed": "2026-07-06", "promotedDate": "2026-07-06", "verificationStatus": "verified-pubmed", "verificationNotes": "PubMed 40892424; NCT03342664. Negative trial; verified 2026-07-06." }, { "id": "chablis-t2", "shortName": "CHABLIS-T II", "fullName": "Tenecteplase Thrombolysis for Stroke up to 24 Hours After Onset With Perfusion Imaging Selection (CHABLIS-T II)", "topic": "extended-window-ivt", "diseaseArea": [ "acute-ischemic-stroke", "extended-window-ivt" ], "population": { "n": 224, "ageRange": "adults", "nihssRange": "", "timeWindow": "4.5-24 h", "keyInclusion": [ "LVO / medium-vessel occlusion", "CT-perfusion target mismatch" ], "keyExclusion": [] }, "intervention": "IV tenecteplase (perfusion-selected)", "comparator": "Standard care / placebo", "primaryEndpoint": { "definition": "Reperfusion / early recanalization + functional outcome", "timepoint": "90 d", "result": "Improved reperfusion without a significant clinical-outcome difference", "effectSize": "", "confidenceInterval": "", "pValue": "" }, "secondaryEndpoints": [ { "name": "Symptomatic ICH", "result": "5.4% vs 4.4%" } ], "safetyFindings": { "sich": "5.4% vs 4.4%", "mortality": "", "other": "" }, "imagingCriteria": "CT perfusion — target mismatch", "applicabilityNotes": "Late-window perfusion-selected TNK; improved reperfusion but no clear clinical benefit. Emerging; not a standard recommendation.", "limitations": "Modest size; surrogate (reperfusion) improved without confirmed clinical benefit.", "certainty": "low", "evidenceType": "rct", "citationIds": [ "cit-chablis-t2-2025" ], "relatedActiveTrialIds": [], "practiceImpact": "Adds to the mixed late-window TNK evidence base; reinforces that reperfusion gains have not consistently translated to clinical benefit.", "lastReviewed": "2026-07-06", "promotedDate": "2026-07-06", "verificationStatus": "verified-pubmed", "verificationNotes": "PubMed 39744861. Effect summary from trial report; verified 2026-07-06." }, { "id": "tempo-2", "shortName": "TEMPO-2", "fullName": "Tenecteplase versus Standard of Care for Minor Ischaemic Stroke with Proven Occlusion (TEMPO-2)", "topic": "tnk-vs-alteplase", "diseaseArea": [ "acute-ischemic-stroke", "tnk-vs-alteplase" ], "population": { "n": 886, "ageRange": "adults", "nihssRange": "0-5 (minor)", "timeWindow": "≤12 h", "keyInclusion": [ "Minor stroke (NIHSS 0-5)", "Intracranial occlusion on CTA" ], "keyExclusion": [] }, "intervention": "IV tenecteplase 0.25 mg/kg", "comparator": "Standard of care (antiplatelet)", "primaryEndpoint": { "definition": "Return to baseline function (mRS 0-1)", "timepoint": "90 d", "result": "No benefit of tenecteplase vs standard of care", "effectSize": "", "confidenceInterval": "", "pValue": "NS" }, "secondaryEndpoints": [ { "name": "Mortality", "result": "Numerically higher with tenecteplase" } ], "safetyFindings": { "sich": "Low in both arms", "mortality": "Numerically higher with tenecteplase", "other": "" }, "imagingCriteria": "CTA — proven intracranial occlusion", "applicabilityNotes": "Thrombolysis did not improve outcomes in minor stroke with occlusion and showed a mortality signal — supports NOT routinely thrombolysing minor (NIHSS 0-5) non-disabling stroke on the basis of occlusion alone.", "limitations": "Applies to minor/non-disabling deficits; does not address disabling deficits with occlusion.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-tempo-2-2024" ], "relatedActiveTrialIds": [], "practiceImpact": "Argues against routine thrombolysis for minor non-disabling stroke solely because an occlusion is present; keep the disabling-deficit gate.", "lastReviewed": "2026-07-06", "promotedDate": "2026-07-06", "verificationStatus": "verified-pubmed", "verificationNotes": "PubMed 38768626; DOI corrected to 10.1016/S0140-6736(24)00921-8. Verified 2026-07-06." }, { "id": "prestige-af", "shortName": "PRESTIGE-AF", "fullName": "Prevention of Stroke in Intracerebral Haemorrhage Survivors with Atrial Fibrillation", "topic": "af-after-ich", "diseaseArea": [ "ich", "af-after-ich", "secondary-prevention" ], "population": { "n": 319, "ageRange": "median 79", "nihssRange": "n/a", "timeWindow": "Spontaneous ICH survivors with AF, mRS ≤4", "keyInclusion": [ "Spontaneous ICH survivor with AF and an anticoagulation indication" ], "keyExclusion": [] }, "intervention": "DOAC (apixaban/dabigatran/edoxaban/rivaroxaban), n=158", "comparator": "No anticoagulation (antiplatelet permitted), n=161", "primaryEndpoint": { "definition": "Coprimary: first ischaemic stroke (superiority) and first recurrent ICH (non-inferiority), ITT", "timepoint": "trial follow-up", "result": "Ischaemic stroke markedly reduced (0.83 vs 8.60 per 100 patient-years); recurrent ICH did NOT meet non-inferiority (5.00 vs 0.82 per 100 patient-years)", "effectSize": "ischaemic HR 0.05; recurrent-ICH HR 10.89", "confidenceInterval": "ischaemic 95% CI 0.01-0.36; ICH 90% CI 1.95-60.72", "pValue": "ischaemic p<0.0001; ICH non-inferiority not met" }, "secondaryEndpoints": [ { "name": "Death", "result": "10% (DOAC) vs 13% (no anticoagulation)" } ], "safetyFindings": { "sich": "Recurrent ICH ~10-fold higher with DOAC", "mortality": "Numerically lower with DOAC (NS)", "other": "Serious adverse events 44% vs 55%" }, "imagingCriteria": "", "applicabilityNotes": "Dedicated ICH-survivor RCT: DOAC lowers ischaemic stroke but raises recurrent ICH; net benefit uncertain in a small trial with few events.", "limitations": "Small (n=319); wide CIs; source uses discordant CI conventions (95% for ischaemic HR, 90% for ICH HR).", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-prestige-af-2025" ], "relatedActiveTrialIds": [], "practiceImpact": "Objective: anticoagulation after ICH in AF trades a large ischaemic-stroke reduction against a substantial recurrent-ICH increase; individualize.", "lastReviewed": "2026-07-18", "promotedDate": "2026-07-18", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "enrich-af", "shortName": "ENRICH-AF", "fullName": "Edoxaban for Intracranial Hemorrhage Survivors with Atrial Fibrillation", "topic": "af-after-ich", "diseaseArea": [ "ich", "af-after-ich", "secondary-prevention" ], "population": { "n": 948, "ageRange": "≥45", "nihssRange": "n/a", "timeWindow": "Intracranial-haemorrhage survivors with high-risk AF (CHA₂DS₂-VASc ≥2)", "keyInclusion": [ "Intracranial haemorrhage survivor with AF" ], "keyExclusion": [] }, "intervention": "Edoxaban 60 mg (30 mg reduced-dose) daily", "comparator": "Non-anticoagulant therapy (none or antiplatelet)", "primaryEndpoint": { "definition": "Coprimary: stroke/systemic embolism; ISTH major haemorrhage", "timepoint": "event-driven (primary completion 2026)", "result": "Full efficacy not yet reported; the lobar-ICH subgroup was stopped by the DSMB for excess recurrent haemorrhagic stroke", "effectSize": "", "confidenceInterval": "", "pValue": "" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "Excess recurrent haemorrhagic stroke in the lobar-ICH (CAA-enriched) subgroup → edoxaban stopped in that subgroup", "mortality": "", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Ongoing; the only reported result to date is a safety signal in lobar ICH. Do not infer net benefit from ENRICH-AF alone.", "limitations": "Primary efficacy pending (2026); lobar-arm-stopped subgroup details partly from secondary reporting.", "certainty": "low", "evidenceType": "rct", "citationIds": [ "cit-enrich-af-2023" ], "relatedActiveTrialIds": [], "practiceImpact": "Objective: interim DSMB stopped edoxaban in lobar ICH for excess rebleeding; the main efficacy comparison is awaited.", "lastReviewed": "2026-07-18", "promotedDate": "2026-07-18", "verificationStatus": "unverified-source-limited", "verificationNotes": "Design/NCT (NCT03950076) and lobar-arm-stopped safety signal verified; full primary efficacy result not yet published (expected 2026)." }, { "id": "sostart", "shortName": "SoSTART", "fullName": "Start or Stop Anticoagulants Randomised Trial", "topic": "af-after-ich", "diseaseArea": [ "ich", "af-after-ich", "secondary-prevention" ], "population": { "n": 203, "ageRange": "adults", "nihssRange": "n/a", "timeWindow": "Survivors of spontaneous intracranial haemorrhage with AF (CHA₂DS₂-VASc ≥2)", "keyInclusion": [ "Spontaneous intracranial haemorrhage survivor with AF" ], "keyExclusion": [] }, "intervention": "Start long-term oral anticoagulation (n=101)", "comparator": "Avoid anticoagulation (antiplatelet or none, n=102)", "primaryEndpoint": { "definition": "Recurrent symptomatic spontaneous intracranial haemorrhage", "timepoint": "~1-2 y", "result": "Inconclusive: 8/101 (8%) start vs 4/102 (4%) avoid; starting NOT shown non-inferior", "effectSize": "adjusted HR 2.42", "confidenceInterval": "95% CI 0.72-8.09", "pValue": "p=0.152" }, "secondaryEndpoints": [ { "name": "Death", "result": "22% (start) vs 11% (avoid)" } ], "safetyFindings": { "sich": "Recurrent ICH numerically higher with anticoagulation (imprecise)", "mortality": "Numerically higher with start", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Pilot-phase non-inferiority RCT; underpowered and inconclusive for the ICH-survivor anticoagulation question.", "limitations": "Small pilot (n=203); wide CIs; open-label.", "certainty": "low", "evidenceType": "rct", "citationIds": [ "cit-sostart-2021" ], "relatedActiveTrialIds": [], "practiceImpact": "Objective: did not establish non-inferiority of starting anticoagulation after ICH; hypothesis-generating.", "lastReviewed": "2026-07-18", "promotedDate": "2026-07-18", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "apache-af", "shortName": "APACHE-AF", "fullName": "Apixaban After Anticoagulation-Associated Intracerebral Haemorrhage in Atrial Fibrillation", "topic": "af-after-ich", "diseaseArea": [ "ich", "af-after-ich", "secondary-prevention" ], "population": { "n": 101, "ageRange": "median 78", "nihssRange": "n/a", "timeWindow": "7-90 d after anticoagulation-associated ICH; AF, CHA₂DS₂-VASc ≥2, mRS ≤4", "keyInclusion": [ "Anticoagulation-associated ICH survivor with AF" ], "keyExclusion": [] }, "intervention": "Apixaban 5 mg (or 2.5 mg) BID (n=50)", "comparator": "Avoid anticoagulation (antiplatelet allowed, n=51)", "primaryEndpoint": { "definition": "Composite of non-fatal stroke or vascular death", "timepoint": "annualized", "result": "No difference: 26% (12.6%/y) apixaban vs 24% (11.9%/y) avoid; high absolute risk in both arms", "effectSize": "adjusted HR 1.05", "confidenceInterval": "95% CI 0.48-2.31", "pValue": "p=0.90" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "", "mortality": "", "other": "Serious adverse events ~57-58% in both arms" }, "imagingCriteria": "", "applicabilityNotes": "Phase-2 feasibility RCT to estimate event rates; not powered for efficacy. ~12%/y absolute risk of non-fatal stroke or vascular death regardless of arm.", "limitations": "Small phase-2 (n=101); imprecise estimate.", "certainty": "low", "evidenceType": "rct", "citationIds": [ "cit-apache-af-2021" ], "relatedActiveTrialIds": [], "practiceImpact": "Objective: no clear difference; both strategies carry high residual vascular risk.", "lastReviewed": "2026-07-18", "promotedDate": "2026-07-18", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "cocroach", "shortName": "COCROACH", "fullName": "Oral Anticoagulation after Intracranial Haemorrhage in AF: Individual-Patient-Data Meta-analysis", "topic": "af-after-ich", "diseaseArea": [ "ich", "af-after-ich", "secondary-prevention" ], "population": { "n": 412, "ageRange": "75% ≥75", "nihssRange": "n/a", "timeWindow": "AF with prior spontaneous intracranial haemorrhage (pooled RCTs: SoSTART, APACHE-AF, NASPAF-ICH)", "keyInclusion": [ "Randomised in an anticoagulation-after-ICH trial" ], "keyExclusion": [] }, "intervention": "Start oral anticoagulation (DOAC in 99%), n=212", "comparator": "Avoid anticoagulation (antiplatelet in 33%), n=200", "primaryEndpoint": { "definition": "Any stroke or cardiovascular death", "timepoint": "pooled", "result": "Favoured anticoagulation but non-significant: 14% vs 22%", "effectSize": "HR 0.68 (I²=0%)", "confidenceInterval": "95% CI 0.42-1.10", "pValue": "NS" }, "secondaryEndpoints": [ { "name": "Ischaemic major adverse cardiovascular events", "result": "4% vs 19%; HR 0.27 (95% CI 0.13-0.56) — significant reduction" }, { "name": "Haemorrhagic MACE", "result": "HR 1.80 (95% CI 0.77-4.21) — numerically higher, NS" } ], "safetyFindings": { "sich": "Recurrent bleeding numerically higher with anticoagulation (NS, wide CI)", "mortality": "", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "IPD meta-analysis of the completed pre-2025 RCTs. Anticoagulation significantly cut ischaemic events; the composite of any stroke/CV death favoured anticoagulation but was not statistically significant; recurrent bleeding was numerically higher.", "limitations": "Pools small trials (n=412); predates PRESTIGE-AF and ENRICH-AF.", "certainty": "moderate", "evidenceType": "meta-analysis", "citationIds": [ "cit-cocroach-2023" ], "relatedActiveTrialIds": [], "practiceImpact": "Objective synthesis: net benefit of anticoagulation after ICH in AF remains statistically uncertain; ischaemic reduction is offset by a non-significant bleeding increase.", "lastReviewed": "2026-07-18", "promotedDate": "2026-07-18", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "switch", "shortName": "SWITCH", "fullName": "Decompressive Craniectomy plus Best Medical Treatment vs Best Medical Treatment Alone for Severe Deep ICH", "topic": "ich-surgery", "diseaseArea": [ "ich", "ich-surgery" ], "population": { "n": 201, "ageRange": "18-75", "nihssRange": "n/a", "timeWindow": "Severe deep (basal ganglia/thalamic) spontaneous ICH", "keyInclusion": [ "Severe deep spontaneous ICH" ], "keyExclusion": [] }, "intervention": "Decompressive craniectomy (no clot evacuation) + best medical treatment (n=96 analysed)", "comparator": "Best medical treatment alone (n=101 analysed)", "primaryEndpoint": { "definition": "mRS 5-6 (death or very severe disability) at 180 d", "timepoint": "180 d", "result": "Favoured surgery numerically but not significant: 44% vs 58%", "effectSize": "adjusted RR 0.77; adjusted risk difference -13%", "confidenceInterval": "RR 95% CI 0.59-1.01; RD 95% CI -26 to 0", "pValue": "p=0.057" }, "secondaryEndpoints": [], "safetyFindings": { "sich": "", "mortality": "Similar", "other": "Severe adverse events 41% (surgery) vs 44% (medical) — no excess with surgery" }, "imagingCriteria": "", "applicabilityNotes": "First RCT of decompressive craniectomy (without evacuation) for severe deep ICH — a distinct surgical modality from clot evacuation (ENRICH/MISTIE III).", "limitations": "Modest size (n=201); primary-outcome CI crossed the null.", "certainty": "moderate", "evidenceType": "rct", "citationIds": [ "cit-switch-2024" ], "relatedActiveTrialIds": [], "practiceImpact": "Objective: numerically fewer very-poor outcomes with craniectomy, but not statistically significant; no safety excess.", "lastReviewed": "2026-07-18", "promotedDate": "2026-07-18", "verificationStatus": "verified-pubmed", "verificationNotes": "" }, { "id": "optimal-bp", "shortName": "OPTIMAL-BP", "fullName": "Intensive vs Conventional Blood Pressure Lowering after Successful Endovascular Thrombectomy", "topic": "bp-post-evt", "diseaseArea": [ "acute-ischemic-stroke", "bp-post-evt" ], "population": { "n": 306, "ageRange": "≥18", "nihssRange": "all", "timeWindow": "After successful EVT (mTICI ≥2b)", "keyInclusion": [ "LVO stroke with successful reperfusion after EVT" ], "keyExclusion": [] }, "intervention": "Intensive SBP <140 mmHg for 24 h (n=155)", "comparator": "Conventional SBP 140-180 mmHg for 24 h (n=150)", "primaryEndpoint": { "definition": "Functional independence (mRS 0-2) at 3 months", "timepoint": "90 d", "result": "Intensive worse: 39.4% vs 54.4%", "effectSize": "adjusted OR 0.56; risk difference -15.1%", "confidenceInterval": "OR 95% CI 0.33-0.96; RD 95% CI -26.2 to -3.9", "pValue": "p=0.03" }, "secondaryEndpoints": [ { "name": "Symptomatic ICH ≤36 h", "result": "9.0% vs 8.1% (NS)" } ], "safetyFindings": { "sich": "No difference (9.0% vs 8.1%)", "mortality": "", "other": "" }, "imagingCriteria": "", "applicabilityNotes": "Second RCT (with ENCHANTED2/MT) showing harm from intensive BP lowering after successful EVT; supports avoiding SBP <140.", "limitations": "Single-country (South Korea); open-label with blinded endpoints.", "certainty": "high", "evidenceType": "rct", "citationIds": [ "cit-optimal-bp-2023" ], "relatedActiveTrialIds": [], "practiceImpact": "Objective: intensive SBP <140 after successful EVT reduced functional independence; reinforces ENCHANTED2/MT.", "lastReviewed": "2026-07-18", "promotedDate": "2026-07-18", "verificationStatus": "verified-pubmed", "verificationNotes": "" } ] }