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Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement
Sponsor: China National Center for Cardiovascular Diseases
Summary
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.
Official title: A Randomized Controlled Trial of Anti-Inflammatory Therapy to Reduce Transcatheter Heart Valve Thrombosis After Transfemoral Transcatheter Aortic Valve Replacement
Key Details
Gender
All
Age Range
60 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2026-03
Completion Date
2028-06
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Colchicine
Colchicine 0.5 mg orally once daily for 12 months
Standard Care
Standard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients
Locations (1)
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China