[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516906":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":29,"studyPopulation":29,"armGroups":50,"interventions":61,"overallOfficials":29,"centralContacts":29,"locations":67,"responsibleParty":99,"collaborators":29,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":29,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":29,"enrollmentInfo":111,"targetDuration":29,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":70,"whyStopped":29,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"General Hospital of Shenyang Military Region","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"proportion of modified Rankin Scale (mRS) 0-1","The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome","90±7 days",[14,16,18,22,24,27,30,32,35,38,40],{"measure":15,"description":11,"timeFrame":12},"proportion of modified Rankin Scale (mRS) 0-2",{"measure":17,"description":11,"timeFrame":12},"ordinal distribution of modified Rankin Scale (mRS)",{"measure":19,"description":20,"timeFrame":21},"change in National Institute of Health stroke scale (NIHSS) score","the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.","24 (-6\u002F+12) hours",{"measure":19,"description":20,"timeFrame":23},"10±2 days",{"measure":25,"description":26,"timeFrame":21},"occurrence of early neurological improvement (ENI)","ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score",{"measure":28,"description":29,"timeFrame":12},"new stroke or other vascular event(s)",null,{"measure":31,"description":29,"timeFrame":12},"all-cause mortality",{"measure":33,"description":34,"timeFrame":21},"symptomatic intracranial hemorrhage (sICH)","sICH is defined as parenchymal hematoma type 1 or 2 (PH1 or PH2), remote intraparenchymal hematoma (RIH), subarachnoid hemorrhage, or intraventricular hemorrhage on head CT\u002FMRI scan causally associated with clinically significant neurological deterioration (NIHSS score ≥4 point increase) in the opinion of the clinical investigator or independent safety monitor.",{"measure":36,"description":37,"timeFrame":21},"intracranial hemorrhage","any evidence of bleeding on the head CT scan, classified by the Heidelberg Bleeding Classification",{"measure":39,"description":29,"timeFrame":21},"major systemic bleeding event",{"measure":41,"description":29,"timeFrame":21},"any bleeding event",{"allocation":43,"interventionModel":44,"interventionModelDescription":29,"primaryPurpose":45,"observationalModel":29,"timePerspective":29,"maskingInfo":46},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":29,"whoMasked":48},"SINGLE",[49],"OUTCOMES_ASSESSOR",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"Tenecteplase group","EXPERIMENTAL","intravenous thrombolysis with tenecteplase",[56],"Drug: Tenecteplase",{"label":58,"type":6,"description":59,"interventionNames":60},"Control group","standard stroke care based on national guideline",[56],[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":29},"DRUG","Tenecteplase","intravenous tenecteplase (0.25 mg\u002Fkg, a single bolus over 5 to 10 seconds, a maximum of 25 mg).",[58,52],[68,88],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Hui-Sheng Chen","RECRUITING","Shenyang","None Selected","110840","China","CN",{"type":77,"coordinates":78},"Point",[79,80],123.43278,41.79222,{"lat":80,"lon":79},[83],{"name":84,"role":85,"phone":86,"phoneExt":29,"email":87},"Yi-Han Wang","CONTACT","+862428897524","wangyihan34732512@163.com",{"facility":89,"status":70,"city":71,"state":29,"zip":90,"country":74,"countryCode":75,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Department of Neurology, General Hospital of Northern Theater Command","110016",{"type":77,"coordinates":92},[79,80],{"lat":80,"lon":79},[95],{"name":96,"role":85,"phone":97,"phoneExt":29,"email":98},"Hui-Sheng Chen, Ph.D.","+86 13352452086","chszh@aliyun.com",{"type":100,"investigatorFullName":69,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Director","100516906","phase-4-tenecteplase-for-acute-ischemic-stroke-within-45-to-6-hours-of-onset-exit-bt2-100516906",false,"NCT06010628","Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)","Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2): a Prospective, Randomized, Open Label, Blinded Endpoint, and Multi-center Study","Inclusion Criteria:\n\n* Age ≥ 18 year\n* Acute ischemic stroke confirmed by non-contrast computed tomography and use of CTA for assessment of LVO as determined by local investigators;\n* The time from last known well to treatment: 4.5 - 6 hours;\n* NIHSS ≥ 4 at randomization;\n* First stroke onset or past stroke without obvious neurological deficit (mRS≤1);\n* Uncertainty over the benefits and risks of thrombolysis by researcher;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Pre-stroke disability (mRS≥2);\n* Planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion;\n* Any contraindication to intravenous thrombolysis: Obvious head injury or stroke within 3 months; Subarachnoid or intracranial hemorrhage; History of intracranial hemorrhage; Intracranial tumor, arteriovenous malformation or aneurysm; Intracranial or spinal cord surgery within 3 months; Myocardial infarction within 3 months; Major surgery within 1 month; Gastrointestinal or urinary tract hemorrhage within the previous 30 days; Arterial puncture at a noncompressible site within the previous seven days; Active internal hemorrhage; Coagulation abnormalities: platelet count of \\\u003C100000\u002Fmm3; Aortic arch dissection; Heparin therapy within 24 hours; Infective endocarditis; Oral warfarin is being taken and INR\\>1.6 or APTT abnormal; Systolic pressure ≥185 mmHg or diastolic pressure ≥110 mmHg; Blood glucose \\\u003C 50 mg\u002Fdl (2.7mmol\u002FL); Neurological deficit after epileptic seizures;\n* Pregnancy;\n* Allergy to test drugs;\n* Comorbidity with other serious diseases;\n* Participating in other clinical trials within 3 months;\n* Patients not suitable for the study considered by researcher.","ALL","18 Years",{"count":112,"type":113},1440,"ESTIMATED","INTERVENTIONAL",[116],"PHASE4","To date, the benefit of intravenous thrombolysis is confined within 4.5 hours of onset for acute ischemic stroke (AIS) patients without advanced neuroimaging selection. Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of intravenous tenecteplase (TNK) in AIS within 4.5 to 6 hours of onset. The current study aims to investigate the efficacy and safety of TNK for AIS within 4.5 to 6 hours of onset.",[119],"Stroke, Ischemic",[121],"thrombolysis","2026-09-08",{"date":124,"type":125},"2026-09-10","ACTUAL",{"date":127,"type":125},"2024-02-01",{"date":129,"type":113},"2029-12-15",{"name":5,"class":6},2]