[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634494":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":44,"locations":49,"responsibleParty":65,"collaborators":27,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":27,"enrollmentInfo":79,"targetDuration":27,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":93,"whyStopped":27,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"The First Affiliated Hospital of Zhengzhou University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Tenecteplase group:","EXPERIMENTAL","Patients will receive tenecteplase, intravenously as a bolus administered over a period of 5 to 10 seconds at a dose of 0.25 mg per kilogram (maximum dose, 25 mg), plus aspirin placebo (300 mg) immediately after randomization.From day 2 to day 90, all patients will be conformed to the 2023 Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke.",[13,14],"Drug: TNK-tPA","Drug: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","ACTIVE_COMPARATOR","Patients will receive asprin(300mg) plus intravenous TNK(placebo, 0.25mg\u002Fkg, a maximum of 25 mg) immediately after randomization. From day 2 to day 90, patients will be conformed to the 2023 Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke.",[20,14],"Drug: Aspirin",[22,28,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","TNK-tPA","TNK-tPA (0.25 mg\u002Fkg, to maximum of 25mg)",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Aspirin","Asprin (300mg)",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Placebo","Asprin (placebo)",[9],{"type":23,"name":33,"description":37,"armGroupLabels":38,"otherNames":27},"TNK-tPA (placebo)",[16],[40],{"name":41,"affiliation":42,"role":43},"Bo Song, MD","Department of Neurology, the First Affiliated Hospital of Zhengzhou University","STUDY_CHAIR",[45],{"name":41,"role":46,"phone":47,"phoneExt":27,"email":48},"CONTACT","+86-371-66278068","fccsongb@zzu.edu.cn",[50],{"facility":51,"status":27,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan","Zhengzhou","Henan","450052","China","CN",{"type":58,"coordinates":59},"Point",[60,61],113.64861,34.75778,{"lat":61,"lon":60},[64],{"name":41,"role":46,"phone":47,"phoneExt":27,"email":48},{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Bo Song","Chief Physician、Professor","100634494","phase-3-tenecteplase-for-late-window-stroke-guided-by-dwi-flair-mismatch-100634494",false,"NCT07540416","Tenecteplase for Late-Window Stroke Guided by DWI-FLAIR Mismatch","Tenecteplase Thrombolysis for Acute Ischemic Stroke in the 4.5-9-Hour Window Guided by DWI-FLAIR Mismatch: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial","TRUST-MISMATCH","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. AIS with symptom onset 4.5-9 hours before enrollment, including wake-up stroke and unwitnessed stroke (onset time defined as when symptoms were first noticed);\n3. Imaging criteria:\n\n   1. DWI-FLAIR mismatch: visible lesion on DWI with no marked visible lesion on FLAIR;\n   2. DWI infarct core not exceeding one-third of the middle cerebral artery territory, one-half of the anterior cerebral artery territory, or one-half of the posterior cerebral artery territory;\n4. NIHSS score 4-25;\n5. First-ever stroke or previous stroke without significant disability (pre-stroke mRS ≤ 1);\n6. Signed informed consent from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n1. Planned endovascular treatment;\n2. Contradictory to MRI examination;\n3. MRI image not qualified for evaluation;\n4. Serious neurological deficits before onset (mRS≥2);\n5. Obvious head injuries or strokes within 3 months;\n6. Subarachnoid or intracranial hemorrhage;\n7. History of intracranial hemorrhage;\n8. Intracranial tumor, arteriovenous malformation or aneurysm;\n9. Intracranial or spinal cord surgery within 3 months;\n10. Active internal hemorrhage;\n11. platelet count of \\\u003C100000\u002Fmm3;\n12. Aortic arch dissection;\n13. Heparin therapy within 24 hours;\n14. Oral warfarin is being taken and INR\\>1.6 or APTT abnormal;\n15. Oral anticoagulation therapy;\n16. Systolic pressure≥185 mmHg or diastolic pressure≥110 mmHg;\n17. Blood glucose \\\u003C 50 mg\u002Fdl (2.7mmol\u002FL);\n18. Pregnancy;\n19. Neurological deficit after epileptic seizures;\n20. Major surgery within 1 month;\n21. Gastrointestinal or urinary tract hemorrhage within the previous 30 days;\n22. Myocardial infarction within 3 months;\n23. Allergy to study drugs;\n24. Unlikely to adhere to the trial protocol or follow-up;\n25. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study;\n26. Participation in other interventional clinical trials within the previous 3 months.","ALL","18 Years",{"count":80,"type":81},564,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","The goal of this clinical trial is to evaluate the efficacy and safety of tenecteplase administered 4.5-9 hours after stroke onset (defined as the time the patient was first found with symptoms, including wake-up stroke and unwitnessed stroke) in patients with acute ischemic stroke (AIS) guided by DWI-FLAIR mismatch on MRI. The main questions it aims to answer are:\n\n1. Does tenecteplase improve functional outcomes at 90 days compared with standard treatments in AIS patients administered 4.5-9 hours after stroke onset guided by DWI-FLAIR mismatch?\n2. The safety of tenecteplase thrombolysis for AIS patients in the 4.5-9 hours guided by DWI-FLAIR mismatch.\n\nResearchers will compare tenecteplase to placebo to see if it is effective and safe for these patients.\n\nParticipants will be randomly assigned (1:1) immediately after randomization:\n\n* Tenecteplase group: received tenecteplase, intravenously as a bolus administered over a period of 5 to 10 seconds at a dose of 0.25 mg per kilogram (maximum dose, 25 mg), plus aspirin placebo (300 mg).\n* Control group: aspirin (300 mg) plus tenecteplase placebo. From day 2 to day 90, all patients will be conformed to the 2023 Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke.",[87],"Acute Ischemic Stroke",[89,90,91,92],"Tenecteplase","Thrombolysis","diffusion weighted imaging","fluid attenuated inversion recovery","NOT_YET_RECRUITING","2026-04-17",{"date":96,"type":97},"2026-04-20","ACTUAL",{"date":99,"type":81},"2026-05-01",{"date":101,"type":81},"2028-06-30",{"name":5,"class":6},1]