[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591967":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":44,"centralContacts":52,"locations":63,"responsibleParty":124,"collaborators":127,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":57,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":57,"enrollmentInfo":141,"targetDuration":57,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":66,"whyStopped":57,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Xinqiao Hospital of Chongqing","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"rhTNK-tPA group","EXPERIMENTAL","Patients in this group will be treated with intravenous rhTNK-tPA and endovascular thrombectomy",[13,14],"Drug: Intravenous rhTNK-tPA","Procedure: Endovascular thrombectomy",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo group","PLACEBO_COMPARATOR","Patients in this group will be treated with intravenous placebo and endovascular thrombectomy",[20,14],"Drug: Intravenous placebo",[22,30,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Intravenous rhTNK-tPA","Patients will received intravenous rhTNK-tPA",[9],[28,29],"Intravenous tenecteplase","Intravenous TNK",{"type":23,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Intravenous placebo","Patients will received intravenous placebo",[16],[35],"Intravenous placebo (a look-alike substance that contains no drug)",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"PROCEDURE","Endovascular thrombectomy","Patients will received endovascular thrombectomy",[16,9],[42,43],"Endovascular treatment","Mechanical thrombectomy",[45,49],{"name":46,"affiliation":47,"role":48},"Qingwu Yang, MD","Department of Neurology, Xinqiao Hospital of the Army Medical University","PRINCIPAL_INVESTIGATOR",{"name":50,"affiliation":51,"role":48},"Daojun Hong, MD","The First Affiliated Hospital of Nanchang University",[53,59],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Zhongming Qiu, MD","CONTACT","13236599269",null,"qiuzhongmingdoctor@163.com",{"name":60,"role":55,"phone":61,"phoneExt":57,"email":62},"Jing Lin, MD","15626456674","linjingsys2016@126.com",[64,83,98,112],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Wuhan No. 1 Hospital","RECRUITING","Wuhan","Hubei","430000","China","CN",{"type":73,"coordinates":74},"Point",[75,76],114.26667,30.58333,{"lat":76,"lon":75},[79],{"name":80,"role":55,"phone":81,"phoneExt":57,"email":82},"Wenhua Liu, MD","8618871588816","leeoowh@yeah.net",{"facility":84,"status":66,"city":85,"state":86,"zip":87,"country":70,"countryCode":71,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Xiangtan Central Hospital","Xiangtan","Hunan","421001",{"type":73,"coordinates":89},[90,91],112.9,27.85,{"lat":91,"lon":90},[94],{"name":95,"role":55,"phone":96,"phoneExt":57,"email":97},"Guangxiong Yuan","18973223018","yuanguangxiong74@163.com",{"facility":99,"status":66,"city":100,"state":101,"zip":57,"country":70,"countryCode":71,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Jiujiang First People's Hospital","Jiujiang","Jiangxi",{"type":73,"coordinates":103},[104,105],116.00206,29.70475,{"lat":105,"lon":104},[108],{"name":109,"role":55,"phone":110,"phoneExt":57,"email":111},"Tuanyuan Zheng, MD","13507925845","85593542@qq.com",{"facility":51,"status":66,"city":113,"state":101,"zip":57,"country":70,"countryCode":71,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Nanchang",{"type":73,"coordinates":115},[116,117],115.85306,28.68396,{"lat":117,"lon":116},[120],{"name":121,"role":55,"phone":122,"phoneExt":57,"email":123},"Daojun Hong","13879187691","hdj@ncu.edu.cn",{"type":48,"investigatorFullName":125,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"Zhongming Qiu","Professor",[128,129],{"name":51,"class":6},{"name":130,"class":131},"China Shijiazhuang Pharmaceutical Company RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO.,LTD","UNKNOWN","100591967","phase-3-intravenous-rhtnk-tpa-before-stroke-thrombectomy-in-the-extended-time-window-100591967",false,"NCT06987305","Intravenous rhTNK-tPA Before Stroke Thrombectomy in the Extended Time Window","Intravenous rhTNK-tPA Versus Placebo Before Endovascular Thrombectomy For Stroke Patient With Large Vessel Occlusion In The Extended Time Window: the BRIDGE-TNK EXTEND Randomized, Placebo-controlled, Double-blind Trial","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Acute ischemic stroke presenting within 4.5-24 hours of last known well;\n3. No significant pre-stroke functional disability: for age \\\u003C80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;\n4. Baseline NIHSS score ≥5;\n5. Imaging criteria of BOTH:\n\n   1. Occlusion on CTA\u002FMRA in one of the following vessels: M1\u002FM2 segment of middle cerebral artery, A1 segment of anterior cerebral artery, V4 segment of vertebral artery, basilar artery, or P1 segment of posterior cerebral artery. For A1, or P1 occlusions, vessel diameter must be ≥0.75 mm;\n   2. For anterior circulation occlusion: CTP\u002FMRP demonstrating mismatch ratio ≥1.8, absolute mismatch volume ≥15 mL, and ischemic core volume \\\u003C70 mL; OR have a mismatch between the presence of an abnormal signal on MRI diffusion-weighted imaging and no visible signal change on FLAIR. For posterior circulation occlusion: pc-ASPECTS score ≥6.\n6. Plan to received endovascular thrombectomy;\n7. The patient or their legal representative provides written informed consent.\n\nExclusion Criteria:\n\n1. Intracranial hemorrhage confirmed by CT\u002FMRI;\n2. Already received intravenous thrombolytic after index stroke.;\n3. Pregnancy or lactation;\n4. Concurrent participation in other investigation drug clinical trials;\n5. Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel;\n6. Pre-existing neurological\u002Fpsychiatric disorders interfering with neurological assessment;\n7. Space-occupying intracranial tumors (except small meningiomas ≤3 cm);\n8. Intracranial aneurysm or arteriovenous malformation;\n9. Terminal illness with life expectancy \\\u003C6 months;\n10. Anticipated inability to complete follow-up assessments.","ALL","18 Years",{"count":142,"type":143},820,"ESTIMATED","INTERVENTIONAL",[146],"PHASE3","This randomized, double-blind, placebo-controlled phase III clinical trial aims to evaluate the efficacy and safety of intravenous recombinant human tenecteplase (rhTNK-tPA) in acute ischemic stroke patients with large vessel occlusion presenting 4.5-24 hours after last known well. The study will address two primary questions: 1) Whether rhTNK-tPA enhances pre-thrombectomy reperfusion rates and improves 90-day functional outcomes compared to placebo; 2) Whether rhTNK-tPA increases the risk of symptomatic intracranial hemorrhage and mortality.\n\nParticipants will be randomized to receive either a single bolus of rhTNK-tPA (0.25 mg\u002Fkg, max 25 mg) or matching placebo administered intravenously over 5 seconds. Key assessments include repeat neuroimaging (CT\u002FCTA or MRI\u002FMRA) at 24 hours post-treatment to evaluate reperfusion, NIH Stroke Scale score at day 5-7, and modified Rankin Scale score assessment at 90 days. Safety monitoring will focus on hemorrhagic transformation and mortality events throughout the study period.",[149],"Stroke, Acute Ischemic",[151,152,153],"acute ischemic stroke","endovascular treatment","rhTNK-tPA","2025-12-24",{"date":156,"type":157},"2025-12-31","ACTUAL",{"date":159,"type":157},"2025-10-21",{"date":161,"type":143},"2028-02-29",{"name":5,"class":6},4]