[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650474":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":49,"locations":59,"responsibleParty":135,"collaborators":44,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":140,"sex":146,"minAge":147,"maxAge":44,"enrollmentInfo":148,"targetDuration":44,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":159,"overallStatus":165,"whyStopped":44,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"rhTNK-tPA+MT","EXPERIMENTAL","Recombinant human TNK tissue-type plasminogen activator for injection (rhTNK-tPA) administered as a single intravenous bolus at a dose of 0.25 mg\u002Fkg (maximum dose 25 mg) within 4.5 hours of symptom onset and prior to mechanical thrombectomy, followed by standard endovascular treatment.",[13],"Drug: rhTNK-tPA (0.25mg\u002Fkg)",{"label":15,"type":10,"description":16,"interventionNames":17},"rPA+MT","Recombinant human plasminogen activator derivative (rPA) administered as two intravenous bolus doses of 18 mg each, given over approximately 2 minutes per bolus and separated by a 30-minute interval. The first dose should be administered within 4.5 hours of symptom onset before mechanical thrombectomy. To avoid delays in reperfusion therapy, groin puncture and endovascular treatment may be initiated after administration of the first bolus without waiting for the second dose. The second bolus should be administered according to the prespecified dosing regimen unless contraindicated.",[18],"Drug: Reteplase 10 Units (U) plus a second dose of reteplase 10 U",{"label":20,"type":21,"description":22,"interventionNames":23},"MT alone","ACTIVE_COMPARATOR","Mechanical thrombectomy performed according to standard practice without administration of intravenous thrombolytic agents.",[24],"Procedure: No thrombolysis (thrombectomy alone)",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","rhTNK-tPA (0.25mg\u002Fkg)","Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) administered as a single intravenous bolus at a dose of 0.25 mg\u002Fkg (maximum dose 25 mg) within 4.5 hours of symptom onset prior to mechanical thrombectomy.",[9],[32],"Tenecteplase",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Reteplase 10 Units (U) plus a second dose of reteplase 10 U","Two intravenous bolus injections of 18 mg each, administered within 4.5 hours of onset over approximately 2 minutes per bolus, separated by a 30-minute interval prior to thrombectomy. To avoid delays in reperfusion therapy, groin puncture and MT procedures may be initiated after administration of the first 18 mg bolus, without waiting for completion of the second bolus. Unless contraindicated, the second rPA bolus should be administered according to the scheduled dosing regimen irrespective of EVT status.",[15],[38],"rPA",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"PROCEDURE","No thrombolysis (thrombectomy alone)","Patients will undergo mechanical thrombectomy according to standard practice, without administration of intravenous thrombolytic agents.",[20],null,[46],{"name":47,"affiliation":5,"role":48},"Yongjun Wang","PRINCIPAL_INVESTIGATOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":44,"email":54},"Yongjun Wang, MD","CONTACT","+86 13911172565","yongjunwang@ncrcnd.org.cn",{"name":56,"role":52,"phone":57,"phoneExt":44,"email":58},"Bowei Zhang, MD","+86 13001139469","boweizhang@ncrcnd.org.cn",[60,76,91,106,121],{"facility":61,"status":44,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Beijing Tiantan Hospital, Capital Medical Universiity","Beijing","Beijing Municipality","100070","China","CN",{"type":68,"coordinates":69},"Point",[70,71],116.39723,39.9075,{"lat":71,"lon":70},[74],{"name":75,"role":52,"phone":57,"phoneExt":44,"email":58},"Bowei Zhang",{"facility":77,"status":44,"city":78,"state":79,"zip":80,"country":65,"countryCode":66,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Zhongnan Hospital of Wuhan University","Wuhan","Hubei","430071",{"type":68,"coordinates":82},[83,84],114.26667,30.58333,{"lat":84,"lon":83},[87],{"name":88,"role":52,"phone":89,"phoneExt":44,"email":90},"Bin Mei","+86 13037196699","neuromei20@163.com",{"facility":92,"status":44,"city":93,"state":94,"zip":95,"country":65,"countryCode":66,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Xiangtan Central Hospital","Xiangtan","Hunan","411100",{"type":68,"coordinates":97},[98,99],112.9,27.85,{"lat":99,"lon":98},[102],{"name":103,"role":52,"phone":104,"phoneExt":44,"email":105},"Feng Huang","+86 18673420807","18673420807@163.com",{"facility":107,"status":44,"city":108,"state":109,"zip":110,"country":65,"countryCode":66,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Rizhao Hospital of Traditional Chinese Medicine","Rizhao","Shandong","625000",{"type":68,"coordinates":112},[113,114],119.52908,35.41414,{"lat":114,"lon":113},[117],{"name":118,"role":52,"phone":119,"phoneExt":44,"email":120},"Lei Mou","+86 13686333377","mlwws0633@163.com",{"facility":122,"status":44,"city":123,"state":124,"zip":110,"country":65,"countryCode":66,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Ya'an People's Hospital","Ya'an","Sichuan",{"type":68,"coordinates":126},[127,128],102.999,29.98521,{"lat":128,"lon":127},[131],{"name":132,"role":52,"phone":133,"phoneExt":44,"email":134},"Jian Wang","+86 13550064528","wangjian0724@126.com",{"type":136,"investigatorFullName":47,"investigatorTitle":137,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"SPONSOR_INVESTIGATOR","Professor, President of Beijing Tiantan Hospital, Capital Medical University","100650474","phase-3-tenecteplase-or-reteplase-as-bridging-thrombolysis-before-thrombectomy-in-acute-ischemic-cerebrovascular-events-100650474",false,"NCT07748039","Tenecteplase or Reteplase as Bridging Thrombolysis Before Thrombectomy in Acute Ischemic Cerebrovascular Events","Tenecteplase or Reteplase as Bridging Thrombolysis Before Thrombectomy in Acute Ischemic Cerebrovascular Events (TRACE-BRIDGE): A Multicenter, Randomized, Open-Label, Three-Arm, Blinded-Endpoint Phase III Trial","TRACE- BRIDGE","Inclusion Criteria:\n\n1. Patients with acute ischemic stroke presenting within 4.5 hours of symptom onset who are eligible for intravenous thrombolytic therapy. A baseline non-contrast CT or MRI is required for screening.\n2. Large vessel occlusion on computed tomographic angiography (CTA) or magnetic resonance angiography (MRA) of the intracranial carotid artery (ICA) or middle cerebral artery (MCA) M1\n3. Age ⩾ 18 years at the time of signing the informed consent form\n4. ASPECTS 6-10\n5. Informed consent from the patients or their legal representative.\n\nExclusion Criteria:\n\n1. Intracranial hemorrhage (ICH) identified by CT or MRI\n2. Rapidly improving symptoms at the discretion of the investigator\n3. mRS \\> 2 before stroke onset.\n4. Massive cerebral infarction (infarct size greater than one-third of the blood middle cerebral artery supply area) suggested by CT.\n5. Known contraindication to imaging with contrast agents\n6. Planned adjunct intra-arterial (IA) thrombolysis during or after endovascular treatment (EVT).\n7. Secondary transfer from a primary stroke center\n8. Any terminal illness such that patient would not be expected to survive more than one year\n9. 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\n10. Pregnant women","ALL","18 Years",{"count":149,"type":150},1440,"ESTIMATED","INTERVENTIONAL",[153],"PHASE3","Acute ischemic stroke caused by large vessel occlusion (LVO) is a major cause of disability, and mechanical thrombectomy (MT) has become the standard treatment for eligible patients. However, the optimal role of intravenous thrombolysis before MT remains uncertain.\n\nThe TRACE-BRIDGE trial is a phase 3, investigator-initiated, multicenter, randomized, open-label trial with blinded outcome assessment (PROBE design) evaluating different bridging thrombolysis strategies before MT. The trial will enroll adults with acute ischemic stroke presenting within 4.5 hours of symptom onset and with imaging-confirmed anterior circulation LVO who are eligible for intravenous thrombolysis and MT.\n\nParticipants will be randomly assigned in a 1:1:1 ratio to receive tenecteplase plus MT, reteplase plus MT, or direct MT alone. The TRACE-BRIDGE trial aims to evaluate the efficacy and safety of bridging thrombolysis with tenecteplase or reteplase before mechanical thrombectomy compared with direct mechanical thrombectomy. The primary outcome is functional independence, defined as a modified Rankin Scale score of 0-2 at 90 days after randomization. If superiority of bridging thrombolysis is demonstrated, the trial will further evaluate whether reteplase is non-inferior to tenecteplase as a bridging thrombolytic strategy.",[156,157,158],"Acute Ischemic Stroke","Large Vessel Occlusion","Anterior Circulation Brain Infarction",[160,161,162,163,164],"acute ischemic stroke","thrombolysis","thrombectomy","tenecteplase","reteplase","NOT_YET_RECRUITING","2026-08-03",{"date":168,"type":169},"2026-08-05","ACTUAL",{"date":171,"type":150},"2026-08-01",{"date":173,"type":150},"2029-08-01",{"name":47,"class":6},5]