[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630100":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":32,"locations":42,"responsibleParty":63,"collaborators":31,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":31,"enrollmentInfo":74,"targetDuration":31,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":86,"whyStopped":31,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"China-Japan Union Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group:Human Urinary Kallidinogenase + Clinical Routine Treatment","EXPERIMENTAL","Intravenous injections of Human urinary kallidinogenase (0.15 PNA units) dissolved in 100 ml of normal saline once a day for 8±1 days",[13],"Drug: Human Urinary Kallidinogenase",{"label":15,"type":6,"description":16,"interventionNames":17},"Control group: Clinical Routine Treatment","Conventional therapy of acute ischemic stroke after based on Chinese guidelines",[18],"Other: Clinical Routine Treatment",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Human Urinary Kallidinogenase","Intravenous injections of urinary kallidinogenase (0.15 PNA units) dissolved in 100 ml of normal saline, administered via slow intravenous drip over no less than 50 minutes,once a day. The solvent can be increased and\u002For slowed down according to the patient's condition for 8±1 days",[9],[26,27],"KLK","HUK",{"type":6,"name":29,"description":16,"armGroupLabels":30,"otherNames":31},"Clinical Routine Treatment",[15],null,[33,38],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Guangxian Nan, MD, Ph.D","CONTACT","+86 13404320500","nangx@jlu.edu.cn",{"name":39,"role":35,"phone":40,"phoneExt":31,"email":41},"Lumei Chi","+86 181 8681 6316","chilm@jlu.edu.cn",[43],{"facility":44,"status":31,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"China-Japan Union Hospital of Jilin University","Changchun","Jilin","130033","China","CN",{"type":51,"coordinates":52},"Point",[53,54],125.32278,43.88,{"lat":54,"lon":53},[57,59,61],{"name":58,"role":35,"phone":36,"phoneExt":31,"email":37},"Guangxian Nan",{"name":34,"role":60,"phone":31,"phoneExt":31,"email":31},"PRINCIPAL_INVESTIGATOR",{"name":39,"role":62,"phone":31,"phoneExt":31,"email":31},"SUB_INVESTIGATOR",{"type":60,"investigatorFullName":58,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Chief Physician","100630100","efficacy-and-safety-of-human-urinary-kallidinogenase-combined-with-reteplase-intravenous-thrombolysis-in-the-treatment-of-acute-ischemic-stroke-100630100",false,"NCT07483281","Efficacy and Safety of Human Urinary Kallidinogenase Combined With Reteplase Intravenous Thrombolysis in the Treatment of Acute Ischemic Stroke","KREATE","Inclusion Criteria:\n\n1. Meet the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023\n2. Age ≥ 18 years\n3. The time from last known well to treatment is within 4.5 hours\n4. First-ever ischemic stroke or have history of ischemic stroke but mRS≤1 before onset\n5. 6 ≤NIHSS≤ 16\n6. Meet the clinical thrombolysis indications in the Chinese Guidelines for the Diagnosis and Treatment of Ischemic Stroke and receive reteplase intravenous thrombolysis\n7. Have provided signed written informed consent from the patient or the patient's legal representative\n\nExclusion Criteria:\n\n1. Preoperative non-contrast head CT shows Alberta Stroke Program Early CT Score (ASPECTS) ≤ 6\n2. Presence of contraindications to intravenous thrombolysis\n3. Patients who have been on angiotensin-converting enzyme inhibitor (ACEI) drugs and within 5 half-lives (according to the specific drug instructions) before initiate Human Urinary Kallidinogenase treatment\n4. Planed for endovascular treatment\n5. Patients with fracture, claudication and other factors affecting functional outcome score upon admission\n6. Use of Edaravone Injection, Edaravone Dexborneol Injection, Sublingual Edaravone Dexborneol, Butylphthalide Injection or Capsules after the onset of the current episode\n7. Severe uncontrolled hypertension: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg\n8. History of severe food or drug allergies, or prior allergy or intolerance to urinary kallidinogenase for injection\n9. Pregnant or lactating women, or patients planning pregnancy within 90 days\n10. Renal failure or severe renal impairment (creatinine clearance \\\u003C 30 mL\u002Fmin) at screening\n11. Liver function impairment: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2.5 times the upper limit of normal, or liver diseases (e.g., acute\u002Fchronic hepatitis, cirrhosis)\n12. Heart failure (NYHA Class III or IV), unstable angina, acute myocardial infarction, severe arrhythmia, or second\u002Fthird-degree cardiac conduction obstruction within 6 months before randomization\n13. Drug abuse or addiction in the past year\n14. Concurrent malignant tumors or severe systemic diseases with an expected survival \\\u003C 90 days\n15. Severe mental disorders or dementia unable to complete the informed consent and follow-up\n16. Participation in any interventional drug or device clinical trial within 3 months before screening\n17. Patients deemed unsuitable for the study by the investigator","ALL","18 Years",{"count":75,"type":76},220,"ESTIMATED","INTERVENTIONAL",[79],"NA","This study is a multicentre, randomized, blinded-endpoint trial that aims to evaluate the efficacy and safety of human urinary kallidinogenase combined with reteplase intravenous thrombolysis in the treatment of acute ischemic stroke",[82],"Acute Ischemic Stroke",[82,22,26,84,27,85],"Reteplase","Intravenous Thrombolysis","NOT_YET_RECRUITING","2026-03-25",{"date":89,"type":90},"2026-03-30","ACTUAL",{"date":92,"type":76},"2026-05-01",{"date":94,"type":76},"2028-06-18",{"name":5,"class":6},1]