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NOT YET RECRUITING
NCT07411768
NA

Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement

Sponsor: China National Center for Cardiovascular Diseases

View on ClinicalTrials.gov

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

Interventions

DRUG

Colchicine

Colchicine 0.5 mg orally once daily for 12 months

OTHER

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