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.
Parallel
Colchicine
DrugColchicine 0.5 mg orally once daily for 12 months
Standard Care
Other interventionStandard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients
Incidence of Transcatheter Heart Valve (THV) Thrombosis
Assessed via 4D-CT imaging to identify leaflet thickening or reduced leaflet motion
Clinical Composite Endpoint: Including stroke, rehospitalization for heart failure, valve dysfunction, and all-cause mortality
Clinical Composite Endpoint: Including stroke, rehospitalization for heart failure, valve dysfunction, and all-cause mortality within 1 year
Dynamic Changes in Inflammatory/Coagulation Biomarkers
Dynamic Changes in Inflammatory/Coagulation Biomarkers: Changes in blood markers from baseline to 1 month and 1 year post-TAVR
Safety Evaluation: Incidence of adverse drug reactions and laboratory abnormalities
Adverse drug reactions: gastrointestinal symptoms (e.g., nausea, diarrhea, vomiting), myalgia, neuritis, skin rash, gout, hospitalization due to infection, new-onset malignancy, etc. Laboratory abnormalities: white blood cell count, absolute neutrophil count, liver and renal function, creatine kinase, etc.
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China National Center for Cardiovascular Diseases
Lead sponsor
Chinese Academy of Medical Sciences
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
