Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07411768
Brief 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.
Study:
NCT07411768
Study Brief:
Protocol Section:
NCT07411768