NCT07411768

Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement

A Randomized Controlled Trial of Anti-Inflammatory Therapy to Reduce Transcatheter Heart Valve Thrombosis After Transfemoral Transcatheter Aortic Valve Replacement

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To ensure balance between the two groups of patients in key prognostic factors, stratified randomization will be used. Stratification factors include: (1) type of implanted prosthetic valve (bulbar valve/self-expanding valve); (2) postoperative baseline antithrombotic regimen (antiplatelet therapy/anticoagulation therapy). Within each stratum, block randomization will be performed using a computer-generated random sequence.

Conditions

• Transcatheter Aortic Valve Replacement
• Transcatheter Heart Valve Thrombosis
• Anti-inflammatory Therapy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2026-02-17
• Last updated: 2026-03-12

Locations

1 site across 1 country: China