[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526634":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":61,"collaborators":29,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":29,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":29,"enrollmentInfo":74,"targetDuration":29,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":85,"whyStopped":29,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"The First Hospital of Jilin University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Urinary Kallidinogenase group","EXPERIMENTAL","Patients are treated with urinary kallidinogenase and guideline-prescribed basic medical therapy.",[13],"Drug: Urinary kallidinogenase for injection",{"label":15,"type":6,"description":16,"interventionNames":17},"Control group","Patients are only treated with guideline-prescribed basic medical therapy.",[18],"Other: Guideline-prescribed medical therapy",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Urinary kallidinogenase for injection","Urinary kallidinogenase 0.15PNA once daily for 7 days.",[9],[26],"Guideline-prescribed medical therapy",{"type":6,"name":26,"description":26,"armGroupLabels":28,"otherNames":29},[15],null,[31],{"name":32,"affiliation":5,"role":33},"Yi Yang, MD,PhD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","13756661217","0086","doctoryangyi@163.com",{"name":41,"role":36,"phone":42,"phoneExt":38,"email":43},"Zhenni Guo, MD,PhD","18186872986","zhen1ni2@163.com",[45],{"facility":46,"status":29,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"First Hospital of Jilin University","Changchun","Jilin","130000","China","CN",{"type":53,"coordinates":54},"Point",[55,56],125.32278,43.88,{"lat":56,"lon":55},[59,60],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},{"name":41,"role":36,"phone":42,"phoneExt":38,"email":43},{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"SPONSOR_INVESTIGATOR","Yi Yang","Associated Dean of the First Hospital of Jilin University","100526634","safety-and-efficacy-of-urinary-kallidinogenase-for-large-artery-atherosclerosis-acute-ischemic-stroke-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":75,"type":76},986,"ESTIMATED","INTERVENTIONAL",[79],"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.",[82],"Acute Ischemic Stroke",[84],"Acute Ischemic Stroke, Urinary Kallidinogenase","NOT_YET_RECRUITING","2024-02-25",{"date":88,"type":89},"2024-02-28","ACTUAL",{"date":91,"type":76},"2024-03-15",{"date":93,"type":76},"2027-12-31",{"name":63,"class":6},1]