[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629609":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":56,"studyPopulation":53,"armGroups":57,"interventions":70,"overallOfficials":53,"centralContacts":79,"locations":89,"responsibleParty":433,"collaborators":53,"id":437,"slug":53,"hasResults":438,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":438,"sex":444,"minAge":445,"maxAge":53,"enrollmentInfo":446,"targetDuration":53,"studyType":449,"phases":450,"briefSummary":452,"conditions":453,"keywords":455,"overallStatus":458,"whyStopped":53,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":468},{"fullName":5,"class":6},"First Hospital of China Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":29},[9],{"measure":10,"description":10,"timeFrame":11},"Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days.","3 months after randomization",[13,15,17,19,22,25,27],{"measure":14,"description":14,"timeFrame":11},"Proportion of patients with mRS 0-2 at 90 days.",{"measure":16,"description":16,"timeFrame":11},"Distribution of mRS score at 90 days.",{"measure":18,"description":18,"timeFrame":11},"Rate of vessel recanalization.",{"measure":20,"description":20,"timeFrame":21},"Proportion of patients undergoing rescue mechanical thrombectomy.","cerebral infarction within 24 hours of onset",{"measure":23,"description":23,"timeFrame":24},"Proportion of patients with NIHSS score 0-1 or an improvement of ≥4 points from baseline at 24 hours, 7 days, or discharge (whichever occurs first).","24 hours, 7 days, or discharge after randomization",{"measure":26,"description":26,"timeFrame":11},"Proportion of patients with neurological deterioration at 90 days (increase in NIHSS score ≥4 points from baseline at the 90-day follow-up).",{"measure":28,"description":28,"timeFrame":11},"New vascular events within 90 days (including ischemic stroke, hemorrhagic stroke, myocardial infarction, and vascular death), with independent evaluation of each event.",[30,33,36,38,40,42,44,46],{"measure":31,"description":31,"timeFrame":32},"Increase in NIHSS score ≥4 points within 24 hours, excluding intracranial hemorrhage.","24 hours after randomization",{"measure":34,"description":34,"timeFrame":35},"Symptomatic intracranial hemorrhage (sICH) at 36 hours (ECASS III definition).","36 hours after randomization",{"measure":37,"description":37,"timeFrame":11},"sICH within 90 days (ECASS III definition).",{"measure":39,"description":39,"timeFrame":11},"PH2 intracranial hemorrhage within 90 days (Heidelberg criteria: hematoma occupying ≥30% of the infarcted area with significant mass effect).",{"measure":41,"description":41,"timeFrame":11},"Any intracranial hemorrhage within 90 days.",{"measure":43,"description":43,"timeFrame":11},"Severe bleeding events in other parts of the body within 90 days (GUSTO definition).",{"measure":45,"description":45,"timeFrame":11},"Death within 90 days.",{"measure":47,"description":47,"timeFrame":11},"Adverse events\u002FSerious adverse events (AE\u002FSAE) within 90 days.",{"allocation":49,"interventionModel":50,"interventionModelDescription":51,"primaryPurpose":52,"observationalModel":53,"timePerspective":53,"maskingInfo":54},"RANDOMIZED","PARALLEL","Multicenter, randomized, open-label, blinded-endpoint (PROBE design), 1:1 allocation, 90-day follow-up.","TREATMENT",null,{"masking":55,"maskingDescription":51,"whoMasked":53},"NONE","Stroke is a leading cause of death and disability. Minor stroke (NIHSS ≤5) accounts for 48% of ischemic strokes, with its \"mild symptom\" presentation masking the potential risk of disability. About 30% of patients have poor 90-day outcomes (mRS ≥2) due to disabling deficits (e.g., unilateral limb weakness ≥2, aphasia, or hemianopia), resulting not only in loss of personal independence but also a surge in family and social medical expenses. Notably, up to 55% of patients present beyond the standard time window (4.5-24 hours). Having missed the golden window for thrombolysis, they are often relegated to conservative treatment. When complicated by large vessel occlusion (LVO), the recanalization rate with dual antiplatelet therapy (DAPT) alone is less than 5%, creating a \"silent epidemic\" of accumulating disability risk.\n\nThe PRISMS trial showed no benefit of thrombolysis within 4.5 hours in non-disabling stroke, but due to the exclusion of the LVO subgroup and early termination (actual enrollment only 313), the potential benefit for disabling patients remains an open question. The TEMPO-2 trial found increased mortality (5% vs 1%) in patients receiving tenecteplase (TNK) without selecting for ischemic penumbra, potentially masking recanalization benefits in certain subgroups (e.g., those with mismatch ratio ≥1.8). A subgroup analysis of TEMPO-2 for onset 4.5-12h, minor disabling stroke (median NIHSS 4), showed a 3-month mRS 0-1 rate of 61.7% in the tenecteplase group vs. 47.2% in the standard care group, but this was not statistically significant due to the small subgroup size. While CHANCE series studies confirmed that DAPT reduces the risk of stroke recurrence by 33%, it is ineffective for LVO recanalization, leaving disability rates high.\n\nThe 2023 \"Chinese Guidelines for Clinical Management of Cerebrovascular Diseases\" and the European Stroke Organisation (ESO) guidelines explicitly state that treatment for disabling minor stroke with LVO beyond the time window (4.5-24 hours) lacks a Class I recommendation (Evidence Level C), leaving clinical decision-making in a dilemma without evidence-based guidance.\n\nDAWN\u002FDEFUSE-3\u002FTRACE Ⅲ studies validated the value of imaging selection in thrombectomy, but they excluded patients with NIHSS ≤5, leaving a gap in penumbra assessment criteria for minor stroke.\n\nTherefore, the investigators designed the TIME-MINOR trial to evaluate whether intravenous tenecteplase, guided by multimodal imaging, can improve outcomes in patients with NIHSS ≤5 and LVO presenting 4.5-24 hours after onset.",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"Tenecteplase","EXPERIMENTAL","Tenecteplase (0.25 mg\u002Fkg, intravenous bolus, maximum dose 25 mg) + Standard Medical Management",[63],"Drug: Tenecteplase (0.25mg\u002Fkg)",{"label":65,"type":66,"description":67,"interventionNames":68},"Standard Medical Management","ACTIVE_COMPARATOR","Immediate Standard Medical Management",[69],"Drug: Standard Medical Management",[71,76],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":53},"DRUG","Tenecteplase (0.25mg\u002Fkg)","Tenecteplase (0.25 mg\u002Fkg, intravenous bolus, maximum dose 25 mg) + Delayed dual antiplatelet therapy (initiated 24 hours after thrombolysis: Aspirin 100 mg orally once daily + Clopidogrel 75 mg orally once daily, or Aspirin 100 mg + Ticagrelor 90 mg orally twice daily, continued for 21 days)",[59],{"type":72,"name":65,"description":77,"armGroupLabels":78,"otherNames":53},"Immediate dual antiplatelet therapy (Aspirin 100 mg orally once daily + Clopidogrel 75 mg orally once daily, or Aspirin 100 mg + Ticagrelor 90 mg orally twice daily, continued for 21 days)",[65],[80,85],{"name":81,"role":82,"phone":83,"phoneExt":53,"email":84},"Chuansheng Zhao, M.D","CONTACT","+86 13940369251","cszhao@mail.cmu.edu.cn",{"name":86,"role":82,"phone":87,"phoneExt":53,"email":88},"Jinwei Li, M.D","+86 15804060747","lijinw07@126.com",[90,107,121,131,144,157,170,183,192,205,215,228,241,254,267,280,293,303,313,323,329,339,349,355,365,378,388,398,411,420],{"facility":91,"status":53,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"Fujian Medical University Union Hospital","Fuzhou","Fujian","350001","China","CN",{"type":98,"coordinates":99},"Point",[100,101],119.30611,26.06139,{"lat":101,"lon":100},[104],{"name":105,"role":82,"phone":106,"phoneExt":53,"email":88},"Wenhuo Chen, M.D","+86 13806906089",{"facility":108,"status":53,"city":109,"state":110,"zip":111,"country":95,"countryCode":96,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Anshan Central Hospital","Anshan","Liaoning","114001",{"type":98,"coordinates":113},[114,115],122.99,41.12361,{"lat":115,"lon":114},[118],{"name":119,"role":82,"phone":120,"phoneExt":53,"email":53},"Hongbo Xiao","+86 13942211121",{"facility":122,"status":53,"city":109,"state":110,"zip":123,"country":95,"countryCode":96,"cosmosGeoPoint":124,"geoPoint":126,"contacts":127},"Anshan Changda Hospital","114005",{"type":98,"coordinates":125},[114,115],{"lat":115,"lon":114},[128],{"name":129,"role":82,"phone":130,"phoneExt":53,"email":53},"Yulin Song","+86 18941269240",{"facility":132,"status":53,"city":133,"state":110,"zip":134,"country":95,"countryCode":96,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Benxi Central 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15040593175",{"facility":171,"status":53,"city":172,"state":110,"zip":173,"country":95,"countryCode":96,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Dandong Central Hospital","Dandong","118000",{"type":98,"coordinates":175},[176,177],124.39472,40.12917,{"lat":177,"lon":176},[180],{"name":181,"role":82,"phone":182,"phoneExt":53,"email":53},"Ming Sun","+86 13842590407",{"facility":184,"status":53,"city":172,"state":110,"zip":173,"country":95,"countryCode":96,"cosmosGeoPoint":185,"geoPoint":187,"contacts":188},"Dandong First Hospital",{"type":98,"coordinates":186},[176,177],{"lat":177,"lon":176},[189],{"name":190,"role":82,"phone":191,"phoneExt":53,"email":53},"Lishu Wan","+86 18004955099",{"facility":193,"status":53,"city":194,"state":110,"zip":195,"country":95,"countryCode":96,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Fushun Central Hospital","Fushun","113006",{"type":98,"coordinates":197},[198,199],123.94363,41.88669,{"lat":199,"lon":198},[202],{"name":203,"role":82,"phone":204,"phoneExt":53,"email":53},"Yan Yang","+86 13941358008",{"facility":206,"status":53,"city":194,"state":110,"zip":207,"country":95,"countryCode":96,"cosmosGeoPoint":208,"geoPoint":210,"contacts":211},"Liaojian Group Fukuang General Hospital","113008",{"type":98,"coordinates":209},[198,199],{"lat":199,"lon":198},[212],{"name":213,"role":82,"phone":214,"phoneExt":53,"email":53},"Hong Zhang","+86 13941363522",{"facility":216,"status":53,"city":217,"state":110,"zip":218,"country":95,"countryCode":96,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Fuxin People's Hospital","Fuxin","123000",{"type":98,"coordinates":220},[221,222],121.65889,42.01556,{"lat":222,"lon":221},[225],{"name":226,"role":82,"phone":227,"phoneExt":53,"email":53},"Ying Bao","+86 13384189988",{"facility":229,"status":53,"city":230,"state":110,"zip":231,"country":95,"countryCode":96,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Huludao Central Hospital","Huludao","125000",{"type":98,"coordinates":233},[234,235],120.83552,40.75243,{"lat":235,"lon":234},[238],{"name":239,"role":82,"phone":240,"phoneExt":53,"email":53},"Changming Xu","+86 15382008866",{"facility":242,"status":53,"city":243,"state":110,"zip":244,"country":95,"countryCode":96,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"The First Affiliated Hospital of Jinzhou Medical University","Jinzhou","121001",{"type":98,"coordinates":246},[247,248],121.14167,41.10778,{"lat":248,"lon":247},[251],{"name":252,"role":82,"phone":253,"phoneExt":53,"email":53},"Li Liu","+86 13591642556",{"facility":255,"status":53,"city":256,"state":110,"zip":257,"country":95,"countryCode":96,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"Liaoyang Central Hospital","Liaoyang","111000",{"type":98,"coordinates":259},[260,261],123.17306,41.27194,{"lat":261,"lon":260},[264],{"name":265,"role":82,"phone":266,"phoneExt":53,"email":53},"Xinbin Hao","+86 13841998567",{"facility":268,"status":53,"city":269,"state":110,"zip":270,"country":95,"countryCode":96,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"Panjin Central Hospital","Panjin","124010",{"type":98,"coordinates":272},[273,274],122.0739,41.121,{"lat":274,"lon":273},[277],{"name":278,"role":82,"phone":279,"phoneExt":53,"email":53},"Zhuo Li","+86 18942750777",{"facility":281,"status":53,"city":282,"state":110,"zip":283,"country":95,"countryCode":96,"cosmosGeoPoint":284,"geoPoint":288,"contacts":289},"The Second Affiliated Hospital of Shenyang Medical College","Shenyang","110002",{"type":98,"coordinates":285},[286,287],123.43278,41.79222,{"lat":287,"lon":286},[290],{"name":291,"role":82,"phone":292,"phoneExt":53,"email":53},"Yan Du","+86 18002453421",{"facility":294,"status":53,"city":282,"state":110,"zip":295,"country":95,"countryCode":96,"cosmosGeoPoint":296,"geoPoint":298,"contacts":299},"Liaoning Provincial People's Hospital","110016",{"type":98,"coordinates":297},[286,287],{"lat":287,"lon":286},[300],{"name":301,"role":82,"phone":302,"phoneExt":53,"email":53},"Muhui Lin","+86 17702485111",{"facility":304,"status":53,"city":282,"state":110,"zip":305,"country":95,"countryCode":96,"cosmosGeoPoint":306,"geoPoint":308,"contacts":309},"Shenyang Fifth People's Hospital","110023",{"type":98,"coordinates":307},[286,287],{"lat":287,"lon":286},[310],{"name":311,"role":82,"phone":312,"phoneExt":53,"email":53},"Jinchun Wang","+86 13889228138",{"facility":314,"status":53,"city":282,"state":110,"zip":315,"country":95,"countryCode":96,"cosmosGeoPoint":316,"geoPoint":318,"contacts":319},"Central Hospital Affiliated to Shenyang Medical College","110024",{"type":98,"coordinates":317},[286,287],{"lat":287,"lon":286},[320],{"name":321,"role":82,"phone":322,"phoneExt":53,"email":53},"Runhui Li","+86 18002477116",{"facility":324,"status":53,"city":282,"state":110,"zip":325,"country":95,"countryCode":96,"cosmosGeoPoint":326,"geoPoint":328,"contacts":53},"Shenyang Fourth People's Hospital","110031",{"type":98,"coordinates":327},[286,287],{"lat":287,"lon":286},{"facility":330,"status":53,"city":282,"state":110,"zip":331,"country":95,"countryCode":96,"cosmosGeoPoint":332,"geoPoint":334,"contacts":335},"The Fourth Affiliated Hospital of China Medical University","110032",{"type":98,"coordinates":333},[286,287],{"lat":287,"lon":286},[336],{"name":337,"role":82,"phone":338,"phoneExt":53,"email":53},"Zhenwei He","+86 18900913396",{"facility":340,"status":53,"city":282,"state":110,"zip":341,"country":95,"countryCode":96,"cosmosGeoPoint":342,"geoPoint":344,"contacts":345},"Shenyang First People's Hospital","110041",{"type":98,"coordinates":343},[286,287],{"lat":287,"lon":286},[346],{"name":347,"role":82,"phone":348,"phoneExt":53,"email":53},"Li Li","+86 13840247222",{"facility":350,"status":53,"city":282,"state":110,"zip":351,"country":95,"countryCode":96,"cosmosGeoPoint":352,"geoPoint":354,"contacts":53},"Shenyang Tenth People's Hospital","110044",{"type":98,"coordinates":353},[286,287],{"lat":287,"lon":286},{"facility":356,"status":53,"city":282,"state":110,"zip":357,"country":95,"countryCode":96,"cosmosGeoPoint":358,"geoPoint":360,"contacts":361},"Sujiatun District Central Hospital","110101",{"type":98,"coordinates":359},[286,287],{"lat":287,"lon":286},[362],{"name":363,"role":82,"phone":364,"phoneExt":53,"email":53},"Hongxia Zhao","+86 13842001757",{"facility":366,"status":53,"city":367,"state":110,"zip":368,"country":95,"countryCode":96,"cosmosGeoPoint":369,"geoPoint":373,"contacts":374},"Tieling Central Hospital","Tieling","112000",{"type":98,"coordinates":370},[371,372],123.84139,42.29306,{"lat":372,"lon":371},[375],{"name":376,"role":82,"phone":377,"phoneExt":53,"email":53},"Yong Liang","+86 13941047667",{"facility":379,"status":53,"city":367,"state":110,"zip":380,"country":95,"countryCode":96,"cosmosGeoPoint":381,"geoPoint":383,"contacts":384},"Tieling County Central Hospital","112600",{"type":98,"coordinates":382},[371,372],{"lat":372,"lon":371},[385],{"name":386,"role":82,"phone":387,"phoneExt":53,"email":53},"Liying Shen","+86 13804107177",{"facility":389,"status":53,"city":367,"state":110,"zip":390,"country":95,"countryCode":96,"cosmosGeoPoint":391,"geoPoint":393,"contacts":394},"Liaojian Group Tieling Coal General Hospital","112700",{"type":98,"coordinates":392},[371,372],{"lat":372,"lon":371},[395],{"name":396,"role":82,"phone":397,"phoneExt":53,"email":53},"Gaohua Li","+86 15694138278",{"facility":399,"status":53,"city":400,"state":110,"zip":401,"country":95,"countryCode":96,"cosmosGeoPoint":402,"geoPoint":406,"contacts":407},"Wafangdian Central Hospital","Wafangdian","116300",{"type":98,"coordinates":403},[404,405],122.00806,39.61833,{"lat":405,"lon":404},[408],{"name":409,"role":82,"phone":410,"phoneExt":53,"email":53},"Wei Li","+86 15566896782",{"facility":412,"status":53,"city":400,"state":110,"zip":401,"country":95,"countryCode":96,"cosmosGeoPoint":413,"geoPoint":415,"contacts":416},"Wafangdian Third People's Hospital",{"type":98,"coordinates":414},[404,405],{"lat":405,"lon":404},[417],{"name":418,"role":82,"phone":419,"phoneExt":53,"email":53},"Renlin Zou","+86 15641120499",{"facility":421,"status":53,"city":422,"state":110,"zip":423,"country":95,"countryCode":96,"cosmosGeoPoint":424,"geoPoint":428,"contacts":429},"Yingkou Central Hospital","Yingkou","115000",{"type":98,"coordinates":425},[426,427],122.23176,40.66472,{"lat":427,"lon":426},[430],{"name":431,"role":82,"phone":432,"phoneExt":53,"email":53},"Dongqun Li","+86 13941728080",{"type":434,"investigatorFullName":435,"investigatorTitle":436,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"PRINCIPAL_INVESTIGATOR","Chuansheng Zhao","Professor","100629609",false,"NCT07476898","Precision Reperfusion Therapy for Disabling Minor Stroke With Large Vessel Occlusion Beyond Time Window","A Multicenter, Randomized, Open-Label, Blinded-Endpoint Trial of Tenecteplase Versus Dual Antiplatelet Therapy in Mild Disabling Ischemic Stroke With Large Vessel Occlusion Beyond 4.5 Hours (TIME-MINOR Trial)","TIME-MINOR","Inclusion Criteria:\n\n* Male or female subjects (age ≥ 18 years).\n* Diagnosis of acute ischemic stroke, with intracranial hemorrhage ruled out by CT or MRI.\n* Time from stroke onset or last known well to randomization is 4.5 to 24 hours.\n* NIHSS score 2-5 and meeting the definition of disabling deficit: complete hemianopia (NIHSS question 3 score ≥ 2); severe aphasia (NIHSS question 9 score ≥ 2); neglect (NIHSS question 11 score ≥ 1); any persistent limb weakness against gravity (NIHSS question 6 or 7 score ≥ 2); any functional deficit considered potentially disabling by the physician and patient, such as inability to perform basic activities of daily living (bathing, independent walking, toileting, personal hygiene, and eating) or return to work.\n* LVO (internal carotid artery, middle cerebral artery M1\u002FM2 segments) confirmed by CTA or MRA, including tandem lesions.\n* Core infarct volume \\\u003C 70 ml, ischemic penumbra volume ≥ 15 ml, and mismatch ratio ≥ 1.8, as shown by CTP or MRI+MRP.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Significant pre-stroke neurological deficit (pre-stroke mRS ≥ 2).\n* History of stroke within the last 3 months.\n* History of intracranial hemorrhage.\n* Suspected subarachnoid hemorrhage.\n* Intracranial tumor, vascular malformation, or aneurysm.\n* Major surgery within the last 1 month.\n* Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.\n* Platelet count \\\u003C 10⁵\u002Fmm³.\n* Heparin or oral anticoagulant therapy within 48 hours.\n* Abnormal APTT.\n* Thrombin or factor Xa inhibitors.\n* Severe illness with life expectancy \\\u003C 3 months.\n* Blood glucose \\\u003C 50 mg\u002FdL (2.7 mmol\u002FL).\n* Participation in any other investigational drug or device study within the last 3 months.\n* Pregnancy.\n* Patients deemed unsuitable for the registry study by the investigator.","ALL","18 Years",{"count":447,"type":448},864,"ESTIMATED","INTERVENTIONAL",[451],"PHASE3","To verify the efficacy and safety of intravenous tenecteplase (TNK) in patients with disabling minor stroke and large vessel occlusion (LVO) within a 4.5-24 hour time window.",[454],"Stroke",[456,59,457],"Ischemic Stroke with Large Vessel Occlusion","beyond 4.5 hours","NOT_YET_RECRUITING","2026-03-12",{"date":461,"type":462},"2026-03-17","ACTUAL",{"date":464,"type":448},"2026-03-01",{"date":466,"type":448},"2028-08-01",{"name":5,"class":6},30]