drugset / Trial / NCT07411768

Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement

NCT07411768

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-03
Primary completion
2028-06
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Colchicine Small molecule 0.5 mg Oral

Indications