[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561221":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":58,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":91,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Capital Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tirofiban Group","EXPERIMENTAL","Patients will receive tirofiban in the first 24 hours after intravenous thrombolysis, then bridge to oral antiplatelet therapy.",[13],"Drug: Tirofiban Hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Aspirin, clopidogrel, or other antiplatelet drugs will be used in principle after 24 hours of thrombolytic therapy or until the primary outcome occurs.",[19],"Drug: Standard medical treatment (SMT)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tirofiban Hydrochloride","Tirofiban will use a loading dose, 0.4 μg\u002Fkg\u002Fmin × 30 minutes, then 0.1μg\u002Fkg\u002Fmin infusion until 24 hours after Intravenous thrombolytic therapy, or use a loading dose, 25 μg\u002Fkg, administrated within 3 minutes, then 0.15μg\u002Fkg\u002Fmin infusion until 24 hours after Intravenous thrombolytic therapy.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard medical treatment (SMT)","Patients will receive standard antiplatelet therapy.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"XunMing Ji, MD, PD","CONTACT","86-10-8319-9439","jixm@ccmu.edu.cn",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Wenbo Zhao, MD, PD","86-10-8319-9048","zhaowb@xwh.ccmu.edu.cn",[42],{"facility":43,"status":26,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Xuanwu Hospital, Capital Medical University","Beijing","Beijing Municipality","100053","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56],{"name":38,"role":34,"phone":57,"phoneExt":26,"email":40},"010-8319-9048",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":62,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Ji Xunming,MD,PhD","Professor","Xuanwu Hospital, Beijing","100561221","phase-2-tirofiban-for-the-prevention-of-early-neurological-deterioration-after-intravenous-thrombolysis-in-acute-ischemic-stroke-100561221",false,"NCT06587347","Tirofiban for the Prevention of Early Neurological Deterioration After Intravenous Thrombolysis in Acute Ischemic Stroke","Effects of Tirofiban on Early Neurological Deterioration After Intravenous Thrombolysis in Patients With Acute Ischemic Stroke: an Open-label, Multicenter, Randomized Controlled Trial","TREND-2","Inclusion Criteria:\n\n1. Age ≥18 years old;\n2. Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of onset or time last known well and can receive the study drug treatment within 3 hours of initiating intravenous thrombolysis.\n3. Residual NIHSS score ≥ 5 points at randomization (at least 1 hour after intravenous thrombolytic therapy).\n4. Post-thrombolysis imaging shows that the offending artery is consistent with moderate or severe intracranial atherosclerotic stenosis (within 50%\\~99%)\n5. Informed consent obtained from patients or their acceptable surrogates.\n\nExclusion Criteria:\n\n1. Intracranial hemorrhage confirmed by imaging post-thrombolysis.\n2. Stroke caused by other determined causes, including moyamoya disease, artery dissection, arteritis, etc.\n3. Scheduled for or received endovascular treatment after onset.\n4. Definite or suspected cardioembolic stroke.\n5. Definite anticipation of developing indications for anticoagulant therapy during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid syndrome, hypercoagulable state).\n6. Use of antiplatelet or anticoagulant therapy within one week pre-stroke.\n7. Pre-stroke mRS score ≥ 2.\n8. Severe consciousness disturbance with NIHSS item 1a (level of consciousness) \\>1 point at randomization.\n9. History of tirofiban allergy or its solvents.\n10. History of platelet count \\\u003C 100 × 109\u002FL caused by tirofiban.\n11. Major surgical operation within 6 weeks.\n12. Major systemic hemorrhage within 30 days;\n13. Determined coagulation disorders, platelet dysfunction, or platelet count \\\u003C 100\\*109\u002FL.\n14. Currently pregnant or lactating;\n15. Uncontrolled hypertension with systolic blood pressure \\> 180 mmHg or diastolic blood pressure \\> 110 mmHg.\n16. Acute pericarditis or hemorrhagic retinopathy.\n17. Presence of malignant tumors, chronic hemodialysis, severe renal insufficiency (GFR \\\u003C 30 ml\u002Fmin or serum Cr \\> 220 μmol\u002FL (2.5 mg\u002Fdl)), severe hepatic insufficiency (serum ALT \\> 2 times the upper limit of normal, or serum AST \\> 2 times the upper limit of normal), severe heart failure (NYHA class III or IV).\n18. Severe non-cardiovascular complications with an expected survival of less than 6 months.\n19. Unavailability for follow-up.\n20. Presence of dementia, psychiatric disorders, or other known neurological conditions that complicate follow-up.\n21. Participated in this study in the past.\n22. Current participation in another therapeutic study with ongoing treatment and follow-up.\n23. Other conditions that are not suitable for participation in this study as determined by the investigator.","ALL","18 Years",{"count":74,"type":75},302,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE2","PHASE3","A prospective, multicenter, randomized, controlled, open-label, blinded endpoint trial to evaluate the safety and efficacy of intravenous administration of tirofiban for preventing early neurological deterioration after intravenous thrombolysis in patients with acute ischemic stroke.",[82,83,84],"Acute Stroke","Ischemic Stroke, Acute","Cerebral Infarction",[86,87,88,89,90],"Acute ischemic stroke","Neurological deterioration","Stroke progression","intravenous thrombolysis","Antiplatelet therapy","NOT_YET_RECRUITING","2024-10-28",{"date":94,"type":95},"2024-10-29","ACTUAL",{"date":97,"type":75},"2024-11-20",{"date":99,"type":75},"2026-06-30",{"name":5,"class":6},1]