Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Incidence of Transcatheter Heart Valve (THV) Thrombosis — 1 year
Assessed via 4D-CT imaging to identify leaflet thickening or reduced leaflet motion
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | China | Recruiting |
More China National Center for Cardiovascular Diseases trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07411768 on ClinicalTrials.gov ↗ ← All trials in China