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.
Patients with aortic stenosis aged 60-85 years.
Successful transfemoral TAVR (per VARC-3 criteria).
Voluntary participation with signed Informed Consent Form.
Known hypersensitivity, allergy, or documented intolerance to colchicine.
Hematologic abnormalities defined as hemoglobin <80 g/L or white blood cell count <4.0 × 10⁹/L at screening.
Severe renal impairment defined as creatinine clearance <30 mL/min (calculated by the Cockcroft-Gault formula) or serum creatinine >2 × upper limit of normal (ULN).
Significant hepatic disease, including liver cirrhosis, chronic active hepatitis, hepatic injury (alanine aminotransferase >3 × ULN or total bilirubin >2 × ULN), or cholestasis.
China National Center for Cardiovascular Diseases
Lead sponsor
Chinese Academy of Medical Sciences
Collaborator