[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621848":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":29,"studyPopulation":29,"armGroups":48,"interventions":59,"overallOfficials":29,"centralContacts":29,"locations":64,"responsibleParty":84,"collaborators":29,"id":88,"slug":29,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":29,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":29,"overallStatus":67,"whyStopped":29,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"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 excellent functional outcome (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",[14,16,18,22,25,27,30,32,34,36,38],{"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},"occurrence of early neurological improvement (ENI)","ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score (NIHSS); the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome","24 (-6\u002F+12) hours",{"measure":23,"description":24,"timeFrame":21},"change in National Institute of Health stroke scale (NIHSS) score","the minimum and maximum values of National Institute of Health stroke scale (NIHSS) are 0 and 42, respectively; higher NIHSS score mean a worse outcome",{"measure":23,"description":24,"timeFrame":26},"10±2 days",{"measure":28,"description":29,"timeFrame":12},"new stroke or other vascular event(s)",null,{"measure":31,"description":29,"timeFrame":21},"symptomatic intracranial hemorrhage (sICH)",{"measure":33,"description":29,"timeFrame":21},"any intracranial hemorrhage",{"measure":35,"description":29,"timeFrame":21},"major systemic bleeding event",{"measure":37,"description":29,"timeFrame":21},"any bleeding event",{"measure":39,"description":29,"timeFrame":12},"all-cause mortality",{"allocation":41,"interventionModel":42,"interventionModelDescription":29,"primaryPurpose":43,"observationalModel":29,"timePerspective":29,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":29,"whoMasked":46},"SINGLE",[47],"OUTCOMES_ASSESSOR",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"TNK group","EXPERIMENTAL","Tenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg\u002Fkg.",[54],"Drug: Tenecteplase",{"label":56,"type":57,"description":58,"interventionNames":29},"Control group","NO_INTERVENTION","No tenecteplase",[60],{"type":61,"name":62,"description":52,"armGroupLabels":63,"otherNames":29},"DRUG","Tenecteplase",[50],[65],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Yu Cui","RECRUITING","Shenyang","None Selected","110840","China","CN",{"type":74,"coordinates":75},"Point",[76,77],123.43278,41.79222,{"lat":77,"lon":76},[80],{"name":66,"role":81,"phone":82,"phoneExt":29,"email":83},"CONTACT","02428897499","cuiyu.spu@hotmail.com",{"type":85,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Hui-Sheng Chen","Director","100621848",false,"NCT07375953","Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK)","Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK): a Prospective, Randomized, Open Label, Blinded Assessment of Outcome, and Multi-center Study","RITIS-TNK","Inclusion Criteria:\n\n* Age ≥ 18 year;\n* Acute ischemic stroke within 3 hours of onset, having received standard intravenous thrombolysis;\n* Measurable neurological deficit before the first intravenous thrombolysis, with NIHSS ≥ 4;\n* No significant clinical improvement (reduction in NIHSS ≤ 2) or neurological deterioration after initial improvement at 1 hour after the first thrombolysis, with intracranial hemorrhage ruled out by neuroimaging;\n* The second intravenous thrombolysis can be administered within 4.5 hours of onset;\n* First stroke onset or past stroke without obvious neurological deficit (mRS≤1);\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Planed for endovascular treatment;\n* Significant cerebral white matter hyperintensities (Fazekas score 3)；\n* Any coagulation abnormality before the first thrombolysis, including INR \\> 1.5；\n* Pregnancy；\n* Allergy to the investigational drug(s)；\n* Receipt of dual antiplatelet therapy within 24 hours prior to thrombolysis;\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","80 Years",{"count":99,"type":100},120,"ESTIMATED","INTERVENTIONAL",[103],"PHASE2","Despite being the standard pharmacological reperfusion therapy for acute ischemic stroke, intravenous thrombolysis is limited by suboptimal recanalization rates. Tenecteplase (TNK), a newer thrombolytic agent, offers practical advantages over alteplase, including single bolus administration. However, a significant proportion of patients fail to achieve early clinical improvement after standard thrombolysis, likely due to persistent vessel occlusion.\n\nThis study proposes to investigate a rescue strategy for patients who do not show significant neurological improvement within one hour after receiving standard intravenous tenecteplase within 3 hours of stroke onset. The primary objective is to evaluate the safety and feasibility of administering a second dose of tenecteplase in this scenario. The study will also explore the potential efficacy of this approach in improving recanalization and functional outcomes.",[106],"Ischemic Stroke","2026-03-31",{"date":109,"type":110},"2026-04-01","ACTUAL",{"date":112,"type":110},"2026-03-25",{"date":114,"type":100},"2027-12-30",{"name":5,"class":6},1]