[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614712":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":29,"studyPopulation":29,"armGroups":56,"interventions":68,"overallOfficials":29,"centralContacts":29,"locations":74,"responsibleParty":94,"collaborators":29,"id":98,"slug":29,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":29,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":29,"enrollmentInfo":106,"targetDuration":29,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":29,"overallStatus":77,"whyStopped":29,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"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",[14,16,18,22,24,27,30,33,36,39,42],{"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":32,"timeFrame":21},"symptomatic intracranial hemorrhage (sICH)","sICH was defined as any evidence of bleeding on the head computed tomographic scan associated with clinically significant neurological deterioration (≥4-point increase in NIHSS score).",{"measure":34,"description":35,"timeFrame":21},"major systemic bleeding events","Bleeding leading to a decrease in hemoglobin ≥ 2 g\u002FdL or transfusion of ≥ 2 units of blood.",{"measure":37,"description":38,"timeFrame":21},"any bleeding events","Including skin and mucosal bleeding, gingival bleeding, bleeding at other organ sites, and other types of hemorrhage.",{"measure":40,"description":41,"timeFrame":23},"any intracranial hemorrhage","Heidelberg Bleeding Classification",{"measure":43,"description":44,"timeFrame":12},"all-cause mortality","death from any cause",{"allocation":46,"interventionModel":47,"interventionModelDescription":29,"primaryPurpose":48,"observationalModel":29,"timePerspective":29,"maskingInfo":49},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":50,"maskingDescription":29,"whoMasked":51},"QUADRUPLE",[52,53,54,55],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[57,63],{"label":58,"type":59,"description":60,"interventionNames":61},"experimental group","EXPERIMENTAL","Urinary Kallidinogenase with 0.15 PNA units dissolved in 100 ml of normal saline, administered via slow intravenous drip over no less than 50 minutes, once daily",[62],"Drug: Human Urinary Kallidinogenase",{"label":64,"type":65,"description":66,"interventionNames":67},"Control group","PLACEBO_COMPARATOR","Urinary Kallidinogenase with placebo dissolved in 100 ml of normal saline, administered via slow intravenous drip over no less than 50 minutes, once daily",[62],[69],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":29},"DRUG","Human Urinary Kallidinogenase","Human Urinary Kallidinogenase is administered intravenously, with 0.15 PNA units dissolved in 100 ml of normal saline.",[64,58],[75],{"facility":76,"status":77,"city":78,"state":29,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Department of Neurology, General Hospital of Northern Theater Command","RECRUITING","Shenyang","110016","China","CN",{"type":83,"coordinates":84},"Point",[85,86],123.43278,41.79222,{"lat":86,"lon":85},[89],{"name":90,"role":91,"phone":92,"phoneExt":29,"email":93},"Hui-Sheng Chen, Ph.D.","CONTACT","+86 13352452086","chszh@aliyun.com",{"type":95,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Hui-Sheng Chen","Director","100614712",false,"NCT07283159","Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)","Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS): a Prospective, Randomized, Double Blinded and Multi-center Study","Inclusion Criteria:\n\n* Age ≥ 18 year;\n* Acute ischemic stroke confirmed by neuroimaging;\n* The time from last known well to treatment is within 4.5 hours;\n* NIHSS ≥ 6 at randomization;\n* Received intravenous tenecteplase (0.25mg\u002Fkg);\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* Use of Edaravone Injection, Edaravone Dexborneol Injection, Butylphthalide Injection or Capsules after the onset of the current episode；\n* Prior use of ACE inhibitors within a period less than 5 half-lives before the intended administration of Urinary Kallidinogenase for Injection；\n* Pregnancy；\n* Allergy to the investigational drug(s)；\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":107,"type":108},200,"ESTIMATED","INTERVENTIONAL",[111],"PHASE2","Human urinary kallidinogenase (HUK) is a tissue kallikrein extracted from human urine. Under certain conditions, tissue kallikrein can convert kininogen into kallidin and kinins, thereby promoting vascular endothelial function, and exerting anti-inflammatory and antioxidant effects. Preclinical and clinical studies have demonstrated that HUK can salvage the ischemic penumbra and significantly promote the establishment of collateral circulation. Existing research suggests that the combination of HUK with intravenous alteplase significantly improves neurological function in patients with acute ischemic stroke (AIS) without increasing the risk of hemorrhage. However, whether its combination with tenecteplase can further enhance neurological recovery in patients remains unreported. Based on the above discussion, this study aims to investigate the efficacy and safety of combining tenecteplase with HUK in the treatment of AIS.",[114],"Ischemic Stroke","2026-01-22",{"date":117,"type":118},"2026-01-23","ACTUAL",{"date":120,"type":118},"2026-01-20",{"date":122,"type":108},"2027-12-30",{"name":5,"class":6},1]