[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624602":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":51,"collaborators":53,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":26,"overallStatus":78,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"China National Center for Cardiovascular Diseases","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Colchicine Group","EXPERIMENTAL","0.5 mg once daily (QD) orally for 12 months, starting after successful TAVR and stabilization before discharge, on top of standard care.",[13,14],"Drug: Colchicine","Other: Standard Care",{"label":16,"type":17,"description":18,"interventionNames":19},"Conventional Treatment","ACTIVE_COMPARATOR","Standard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients, without the use of colchicine.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Colchicine","Colchicine 0.5 mg orally once daily for 12 months",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"OTHER","Standard Care","Standard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients",[9,16],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Yunqing Ye, MD, PhD","CONTACT","8613699282532","judia8510@163.com",[39],{"facility":40,"status":26,"city":41,"state":26,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":26},"Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College","Beijing","100037","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},{"type":52,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[54],{"name":55,"class":28},"Chinese Academy of Medical Sciences","100624602","low-dose-colchicine-for-thromboprophylaxis-after-transcatheter-aortic-valve-replacement-100624602",false,"NCT07411768","Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement","A Randomized Controlled Trial of Anti-Inflammatory Therapy to Reduce Transcatheter Heart Valve Thrombosis After Transfemoral Transcatheter Aortic Valve Replacement","LoDoCo-TAVR","Inclusion Criteria:\n\n* Patients with aortic stenosis aged 60-85 years.\n* Successful transfemoral TAVR (per VARC-3 criteria).\n* Voluntary participation with signed Informed Consent Form.\n\nExclusion Criteria:\n\n* Known hypersensitivity, allergy, or documented intolerance to colchicine.\n* Hematologic abnormalities defined as hemoglobin \\\u003C80 g\u002FL or white blood cell count \\\u003C4.0 × 10⁹\u002FL at screening.\n* Severe renal impairment defined as creatinine clearance \\\u003C30 mL\u002Fmin (calculated by the Cockcroft-Gault formula) or serum creatinine \\>2 × upper limit of normal (ULN).\n* Significant hepatic disease, including liver cirrhosis, chronic active hepatitis, hepatic injury (alanine aminotransferase \\>3 × ULN or total bilirubin \\>2 × ULN), or cholestasis.\n* Known history of bone marrow suppression.\n* Concomitant use of strong CYP3A4 or P-glycoprotein (P-gp) inhibitors, including but not limited to cyclosporine, amiodarone, clarithromycin, erythromycin, omeprazole, or verapamil.\n* Concomitant use of strong CYP3A4 or P-glycoprotein (P-gp) inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, or rifampin.\n* Known neuromuscular disorders or creatine kinase (CK) \\>3 × ULN at screening.\n* Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea.\n* Active malignancy or history of cancer.\n* Current use of systemic corticosteroids (oral or intravenous) or systemic immunosuppressive agents (topical or inhaled corticosteroids permitted).\n* Acute inflammatory condition or active viral infection at the time of enrollment.\n* Known galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.\n* Estimated life expectancy \\\u003C1 year as determined by the investigator.","ALL","60 Years","85 Years",{"count":68,"type":69},116,"ESTIMATED","INTERVENTIONAL",[72],"NA","This prospective, randomized, open-label study aims to evaluate the efficacy and safety of low-dose colchicine (0.5 mg daily) in reducing transcatheter heart valve (THV) thrombosis in patients after TAVR. Participants will be randomly assigned to either receive colchicine plus standard care or standard care alone for 12 months. The primary goal is to compare the rate of valve thrombosis between the two groups using 4D-CT imaging at one year. Additionally, the study will evaluate the treatment's impact on clinical outcomes and its overall safety profile.",[75,76,77],"Transcatheter Aortic Valve Replacement","Transcatheter Heart Valve Thrombosis","Anti-inflammatory Therapy","NOT_YET_RECRUITING","2026-03-11",{"date":81,"type":82},"2026-03-12","ACTUAL",{"date":84,"type":69},"2026-03",{"date":86,"type":69},"2028-06",{"name":5,"class":6},1]