[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526634":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":35,"studyPopulation":26,"armGroups":36,"interventions":48,"overallOfficials":58,"centralContacts":62,"locations":72,"responsibleParty":89,"collaborators":26,"id":93,"slug":26,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":26,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":26,"enrollmentInfo":101,"targetDuration":26,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":112,"whyStopped":26,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"The First Hospital of Jilin University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days","Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.","90 days",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"National Institute of Health Stroke Scale (NIHSS) at 7days.","National Institute of Health stroke Scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.","7days",{"measure":19,"description":20,"timeFrame":21},"Incidence of ischemic stroke within 90 days.","Including recurrent and new ischemic stroke.","0-90days",{"measure":23,"description":24,"timeFrame":25},"Adverse events occurring in the course of the treatment.","Including all adverse events, severe adverse events and urinary kallidinogenase related adverse events.","0-7days",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":33},"SINGLE",[34],"OUTCOMES_ASSESSOR","Currently, evidence regarding the safety and efficacy of urinary kallidinogenase treatment in patients with acute ischemic stroke lacks, and few of related studies were large-scale and high-quality. Thus, this study was designed to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Urinary Kallidinogenase group","EXPERIMENTAL","Patients are treated with urinary kallidinogenase and guideline-prescribed basic medical therapy.",[42],"Drug: Urinary kallidinogenase for injection",{"label":44,"type":6,"description":45,"interventionNames":46},"Control group","Patients are only treated with guideline-prescribed basic medical therapy.",[47],"Other: Guideline-prescribed medical therapy",[49,56],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"DRUG","Urinary kallidinogenase for injection","Urinary kallidinogenase 0.15PNA once daily for 7 days.",[38],[55],"Guideline-prescribed medical therapy",{"type":6,"name":55,"description":55,"armGroupLabels":57,"otherNames":26},[44],[59],{"name":60,"affiliation":5,"role":61},"Yi Yang, MD,PhD","PRINCIPAL_INVESTIGATOR",[63,68],{"name":60,"role":64,"phone":65,"phoneExt":66,"email":67},"CONTACT","13756661217","0086","doctoryangyi@163.com",{"name":69,"role":64,"phone":70,"phoneExt":66,"email":71},"Zhenni Guo, MD,PhD","18186872986","zhen1ni2@163.com",[73],{"facility":74,"status":26,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"First Hospital of Jilin University","Changchun","Jilin","130000","China","CN",{"type":81,"coordinates":82},"Point",[83,84],125.32278,43.88,{"lat":84,"lon":83},[87,88],{"name":60,"role":64,"phone":65,"phoneExt":66,"email":67},{"name":69,"role":64,"phone":70,"phoneExt":66,"email":71},{"type":90,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Yi Yang","Associated Dean of the First Hospital of Jilin University","100526634",false,"NCT06137300","Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke","Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke：a Multicentre, Prospective, Randomised, Open-label, Blinded-Endpoint Trial","Inclusion Criteria:\n\n1. Age ≥18 years old;\n2. Acute anterior circulation large artery atherosclerotic cerebral infarction (according to TOAST classification) within 48h of onset; NIHSS score ≥6, ≤15;\n3. Moderate to severe stenosis or occlusion of offending vessels;\n4. The mRS Score ≤2 before onset;\n5. Subjects or their legal representatives agreed to the treatment and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Transient ischemic attack;\n2. Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy);\n3. Severe disturbance of consciousness:GCS ≤8;\n4. Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly;\n5. Refractory hypertension: systolic blood pressure ≥200 mmHg or diastolic blood pressure ≥110 mmHg; hypotension: systolic blood pressure \\\u003C 90 mmHg or diastolic blood pressure \\\u003C 60 mmHg;\n6. Liver dysfunction (ALT\u002FAST \\>1.5 × upper limit of normal \\[ULN\\]), renal dysfunction (Cr \\>1 × ULN);\n7. Coagulopathy (prolonged INR (\\>1.5) or prolonged APTT (\\>2 folds);\n8. Cardioembolic stroke or high-risk factors of cardioembolic stroke identified by investigators (atrial fibrillation, cardiac mural thrombus, cardiomyopathy, etc.);\n9. Special populations such as pregnant and lactating women, patients with life expectancy less than 3 months, or patients unable to complete the study for other reasons;\n10. Unwilling to be followed up or poor treatment compliance;\n11. Participating in other clinical investigators, or had participated in other clinical investigators within 3 months before enrollment;\n12. Other conditions considered by the investigator to be inappropriate for enrollment.","ALL","18 Years",{"count":102,"type":103},986,"ESTIMATED","INTERVENTIONAL",[106],"NA","The purpose of this study is to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.",[109],"Acute Ischemic Stroke",[111],"Acute Ischemic Stroke, Urinary Kallidinogenase","NOT_YET_RECRUITING","2024-02-25",{"date":115,"type":116},"2024-02-28","ACTUAL",{"date":118,"type":103},"2024-03-15",{"date":120,"type":103},"2027-12-31",{"name":91,"class":6},1]