[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605880":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":40,"responsibleParty":56,"collaborators":33,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":33,"enrollmentInfo":70,"targetDuration":33,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":33,"overallStatus":82,"whyStopped":33,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"The First Affiliated Hospital of University of Science and Technology of China","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TNK","EXPERIMENTAL","Participants will receive intravenous tenecteplase at a dose of 0.25 mg\u002Fkg (max 25 mg) administered as a bolus after enrollment. Subsequent treatment will be administered with antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.",[13],"Drug: TNK",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard medical management","PLACEBO_COMPARATOR","Participants will receive antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.",[19],"Drug: Standard medical treatment",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","a dose of 0.25 mg\u002Fkg (max 25 mg) administered as a bolus",[9],[26],"tenecteplase",{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Standard medical treatment","antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.",[15],[32],"standard treatment",null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Wei Hu, MD, PhD","CONTACT","+86 055162284313","andinghu@ustc.edu.cn",[41],{"facility":5,"status":33,"city":42,"state":43,"zip":33,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Hefei","Anhui","China","CN",{"type":47,"coordinates":48},"Point",[49,50],117.28083,31.86389,{"lat":50,"lon":49},[53],{"name":54,"role":37,"phone":55,"phoneExt":33,"email":39},"Wei Hu, MD,PhD","+8615155510611",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Wei Hu","Professor","100605880","phase-3-tenecteplase-vs-medical-management-in-45-24h-lvo-no-access-to-evt-100605880",false,"NCT07168278","Tenecteplase vs Medical Management in 4.5-24h LVO no Access to EVT","Tenecteplase vs Medical Management in 4.5-24h Anterior Circulation Large Vessel Occlusion With no Access to EVT","TNK LATE","Inclusion Criteria:\n\n* Age 18 years or greater\n* Acute ischemic stroke presenting in the 4.5 to 24 hour window from last seen well (including wake-up stroke and no witness stroke).\n* Prestroke mRS 0-2\n* NIHSS 6 to 25\n* Aspect ≥ 7\n* ICA terminus, M1, dominant M2 occlusion on CTA or MRA\n* Clinical-imaging mismatch assessed by investigator\n* Patients with no access to EVT at the time of randomization\n\nExclusion Criteria:\n\n* Current or past history of significant bleeding over the past 6 months;\n* History of intracranial hemorrhage (including possible subarachnoid hemorrhage or subarachnoid hemorrhage due to an aneurysm) or evidence or suspected intracranial hemorrhage;\n* Known bleeding tendency;\n* Recent severe or dangerous bleeding, or active ulcerative gastrointestinal disease;\n* History of central nervous system injury (e.g., intracranial tumor, aneurysm, or arteriovenous malformation, intracranial or spinal surgery), or recent head injury；\n* Tumors that increase risk of bleeding;\n* Severe liver dysfunction, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis;\n* Know arterial \u002F venous malformation or aneurysm;\n* Bacterial endocarditis, pericarditis, or acute pancreatitis;\n* Patients receiving effective anticoagulant therapy (vitamin K antagonists with INR \\> 1.3, or other oral anticoagulants exceeding the upper limit of the corresponding standard range);\n* Heparin use within the past 48 hours and prothrombin time exceeding the upper limit of the standard range;\n* Over the past 3 months, undergone major surgery, organ biopsy, or suffered a serious injury;\n* Over the past 2 weeks, receiving prolonged ( \\>2 minutes) cardiopulmonary resuscitation, childbirth, or non-stressful vascular puncture (such as subclavian or jugular vein puncture);\n* Stroke episode occurred with epileptic seizure;\n* History of stroke comorbid with diabetes;\n* History of stroke over the past 3 months；\n* Acute bleeding tendency, including platelet count below 100×10⁹\u002FL or other conditions;\n* SBP \\>185 mmHg or DBP \\>110 mmHg, or requiring intensive treatment (intravenous antihypertensive drugs) to lower blood pressure to within limits;\n* Blood glucose \\\u003C2.8 mmol\u002FL or \\>22.2 mmol\u002FL (\\\u003C50 mg\u002FdL or \\>400 mg\u002FdL)；\n* Patient life expectancy of less than 1 year;\n* Simultaneous occlusion of multiple blood vessels, defined as bilateral MCAs or MCAs combined with the basilar artery;\n* Pregnant women or nursing mothers；\n* Patients with a low likelihood of 3-month follow-up；\n* Over the past 3 months participated in other interventional clinical trials.","ALL","18 Years",{"count":71,"type":72},794,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","The goal of this clinical trial is to learn if tenectplase works to acute ischemic stroke (AIS) with onset 4.5-9 hours. It will also learn about the safety of tenectplase in AIS with onset 4.5-9 hours. The main question it aims to answer is: Does tenectplase improve the 90-days functional outcome in participants with acute large vessel occlusion? Researchers will compare tenectplase thrombolysis to non-use to see if tenectplase works to improve the functional outcome in participants with onset 4.5-9 hours. Participants will:\\* Receive 0.25mg\u002Fkg (max 25mg) tenectplase at admission (after randomization) .\\* Receive neurological assessment at admission, Day 5-7 or on hospital discharge (whichever earlier). Audio or video of the assessment may be recorded if possible.\\* Receive brain CT + CT angiogram + CT perfusion and MRI after randomization, where the CT scan may be repetitive.",[78,79,80,81],"Acute Ischemic Stroke","Large Vessel Occlusion","Tenecteplase","Thrombolysis","NOT_YET_RECRUITING","2025-09-05",{"date":85,"type":86},"2025-09-11","ACTUAL",{"date":88,"type":72},"2025-11-01",{"date":90,"type":72},"2028-05-31",{"name":5,"class":6},1]