[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547940":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":67,"studyPopulation":16,"armGroups":68,"interventions":81,"overallOfficials":91,"centralContacts":95,"locations":100,"responsibleParty":117,"collaborators":16,"id":121,"slug":16,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":16,"enrollmentInfo":130,"targetDuration":16,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":102,"whyStopped":16,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day (± 7 days).","Modified Rankin Scale score, mRS 0-1","at 90-day (± 7 days)",[14,17,20,23,26,29,33,35,37,40,43,46,48,50,52,54],{"measure":15,"description":16,"timeFrame":12},"Good functional outcome (mRS 0-2) at 90-day (± 7 days)",null,{"measure":18,"description":19,"timeFrame":12},"mRS score at 90-day (± 7 days)","shift analysis\u002Fordinal distribution of mRS score at 90-day (±7 days)",{"measure":21,"description":16,"timeFrame":22},"COSMOS Scale 0-1 at 90-day (±7days)","90-day± 7days",{"measure":24,"description":25,"timeFrame":22},"COSMOS scale at 90-day (±7 days)","shift analysis\u002Fordinal distribution of COSMOS scale at 90-day (±7 days)",{"measure":27,"description":16,"timeFrame":28},"NIHSS 0-1 at 24-hour, 7-day or before discharge (analyze which occurs first) or\u002F neurological improvement (NIHSS decreased≥4 from baseline)","at 24-hour, 7-day or before discharge (analyze which occurs first)",{"measure":30,"description":31,"timeFrame":32},"Neurological deterioration at 90 days","defined as an increase of ≥4 points in NIHSS score compared to baseline.","90-day (±7 days)",{"measure":34,"description":16,"timeFrame":12},"New clinical vascular events (ischemic stroke\u002F hemorrhagic stroke\u002F myocardial infarction\u002Fvascular death) at 90-day (± 7 days), with each vascular event being independently evaluated.",{"measure":36,"description":16,"timeFrame":12},"European quality of life visual analogue scale at 90 days",{"measure":38,"description":16,"timeFrame":39},"Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 36-hour.","within 36-hour",{"measure":41,"description":16,"timeFrame":42},"Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 7 days or before discharge.","within 7 days or before discharge",{"measure":44,"description":16,"timeFrame":45},"Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 90-day (± 7 days)","within 90-day (± 7 days)",{"measure":47,"description":16,"timeFrame":45},"PH2 type intracranial hemorrhage according to the Heidelberg criteria within 90-day (± 7 days)",{"measure":49,"description":16,"timeFrame":45},"Any intracranial hemorrhage within 90-day (± 7 days)",{"measure":51,"description":16,"timeFrame":45},"Severe bleeding events according to the GUSTO criteria within 90-day (± 7 days)",{"measure":53,"description":16,"timeFrame":45},"Total mortality within 90-day (± 7 days)",{"measure":55,"description":16,"timeFrame":45},"Adverse events\u002FSevere adverse events within 90-day (± 7 days)",{"allocation":57,"interventionModel":58,"interventionModelDescription":16,"primaryPurpose":59,"observationalModel":16,"timePerspective":16,"maskingInfo":60},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":61,"maskingDescription":16,"whoMasked":62},"QUADRUPLE",[63,64,65,66],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This study is a multicenter, prospective, randomized, double-blind, double-dummy controlled (2 arms with 1:1 randomization) trial. Participants with acute minor ischemic stroke (baseline NIHSS≤5) within 4.5 hours of symptoms onset (symptom onset is defined by the \"last seen normal\" principle for wake-up stroke) will be enrolled. Eligible patients must have neurological deficits involving at least language or motor function. Participants will be randomized into 2 groups: Intervention group (rhTNK-tPA): 0.25mg\u002Fkg, the maximum dose does not exceed 25mg, plus placebo oral aspirin and clopidogrel. Aspirin 100mg and clopidogrel 300mg will be given within 6 ± 2 hours after thrombolytic therapy. Control group: Dual antiplatelet therapy with aspirin 100mg and clopidogrel 300mg, plus placebo intravenous rhTNK-tPA. Placebo oral aspirin and clopidogrel will be given within 6 ± 2 hours following the placebo thrombolytic therapy.The primary endpoint is an excellent functional outcome (a modified Rankin Scale score of 0-1) at 90-day.",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"Aspirin combined with clopidogrel","PLACEBO_COMPARATOR","Aspirin 100mg combined with clopidogrel 300mg, plus placebo intravenous rhTNK-tPA",[74],"Drug: Control group (Aspirin combined with clopidogrel)",{"label":76,"type":77,"description":78,"interventionNames":79},"rhTNK-tPA (0.25 mg\u002Fkg)","EXPERIMENTAL","rhTNK-tPA (0.25 mg\u002Fkg, max 25 mg) with placebo oral aspirin and clopidogrel",[80],"Drug: rhTNK-tPA",[82,87],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":16},"DRUG","rhTNK-tPA","rhTNK-tPA 0.25mg\u002Fkg, the maximum dose does not exceed 25mg: 1 vial is dissolved in 3ml of sterile water for injection to prepare a medicinal solution with a concentration of 5.33mg\u002Fml. Calculate the total amount of the drug according to the weight of participant, and the maximum dose shall not exceed 25 mg. It is administered as a single bolus intravenous injection, and the injection is completed within 5-10 seconds. Additionally, placebo oral aspirin and clopidogrel are given. Aspirin 100 mg and clopidogrel 300 mg are administered within 6 ± 2 hours following thrombolytic therapy.",[76],{"type":83,"name":88,"description":89,"armGroupLabels":90,"otherNames":16},"Control group (Aspirin combined with clopidogrel)","Dual antiplatelets with aspirin 100mg and clopidogrel 300mg, plus placebo intravenous rhTNK-tPA. Placebo oral aspirin and clopidogrel are administered within 6 ± 2 hours following intravenous placebo.",[70],[92],{"name":93,"affiliation":5,"role":94},"Yongjun Wang, MD, PhD","STUDY_DIRECTOR",[96],{"name":93,"role":97,"phone":98,"phoneExt":16,"email":99},"CONTACT","86-13911172565","yongjunwang@ncrcnd.org.cn",[101],{"facility":5,"status":102,"city":103,"state":104,"zip":16,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":113},"RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":108,"coordinates":109},"Point",[110,111],116.39723,39.9075,{"lat":111,"lon":110},[114],{"name":115,"role":97,"phone":16,"phoneExt":16,"email":116},"Yongjun Wang, Dr.","yongjunwang111@aliyun.com",{"type":118,"investigatorFullName":119,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Yongjun Wang","professor","100547940",false,"NCT06414499","Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ","TNK-tPA Treatment for Acute Minor Ischemic Stroke：A Randomized, Double-blind, Double-dummy Controlled Trial","TRACE Ⅳ","Inclusion Criteria\n\n1. Age ≥ 18 years;\n2. Onset-to-treatment time \\\u003C 4.5 h; onset time defined as \"last known well\" time;\n3. Clinical diagnosis of minor ischemic stroke (NIHSS ≤ 5) with persistent unilateral limb weakness or speech symptoms, defined as a score of ≥1 on either the language item or a single limb item of the NIHSS;\n4. Pre-stroke mRS 0-1;\n5. Informed consent signed.\n\nExclusion Criteria\n\n1. Planned or likely acute endovascular treatments before randomization;\n2. NIHSS 1a \\> 2;\n3. Known allergic to rhTNK-tPA;\n4. History of intracranial hemorrhage;\n5. Severe head trauma or previous stroke within 3 months；\n6. Intracranial or spinal surgery within 3 months;\n7. Gastrointestinal or urinary tract hemorrhage within 3 weeks；\n8. Major surgery within 2 weeks;\n9. Arterial puncture at a non-compressible site within 1 week；\n10. Intracranial tumors (excluding neuroectodermal tumors, e.g., meningiomas), large intracranial aneurysms, or arteriovenous malformations；\n11. Intracranial hemorrhage, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural\u002Fepidural hematoma;\n12. Active visceral bleeding;\n13. Concomitantaortic arch dissection;\n14. Acute bleeding tendency, including platelet count \\\u003C100×10⁹\u002FL or other clinically significant conditions;\n15. Uncontrolled hypertension after active antihypertensive treatment: systolic blood pressure \\>180 mm Hg or diastolic \\>100 mm Hg;\n16. Blood glucose \\\u003C 2.8 or \\> 22.2 mmol \u002F L;\n17. Prior anticoagulant therapy, such as oral warfarin, with an INR \\>1.7 or PT \\>15 seconds;\n18. Use of heparin within 24 hours;\n19. Use of thrombin inhibitors or factor Xa inhibitors within 48 hours;\n20. Large cerebral infarction on head CT or MRI (infarction area \\>1\u002F3 of the middle cerebral artery territory);\n21. Todd's paralysis after a seizure or other neurological\u002Fpsychiatric disorders affecting cooperation;\n22. Severe, uncontrolled infections (e.g., acute pericarditis, infective endocarditis, or acute pancreatitis);\n23. Pregnant or breastfeeding women, or women unwilling to use effective contraception during the study period;\n24. Participation in another clinical trial within 3 months prior to screening;\n25. Other severe illnesses with a life expectancy of less than six months;\n26. Deemed unsuitable for the study or at increased risk by the investigator's judgment.","ALL","18 Years",{"count":131,"type":132},1386,"ESTIMATED","INTERVENTIONAL",[135],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of intravenous tenecteplase (0.25 mg\u002Fkg) compared with standard therapy in patients with acute ischemic stroke presenting with mild symptoms-defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤5 accompanied by persistent unilateral limb weakness or speech impairment within 4.5 hours of onset.",[138],"Minor Ischemic Stroke",[140,141],"minor stroke","tenecteplase","2025-07-20",{"date":144,"type":145},"2025-07-24","ACTUAL",{"date":147,"type":145},"2025-07-09",{"date":149,"type":132},"2026-10-31",{"name":5,"class":6},1]