RecruitingPhase 4NCT06901466

STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant

STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-edge Repair in Patients With an Indication for Oral Anticoagulant: a Multicenter Randomized Controlled Trial


Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Enrollment

880 participants

Start Date

Jun 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Mitral regurgitation (MR) is the most common valvular heart disease, affecting approximately 24.2 million people worldwide (with a higher prevalence in older age groups). Transcatheter edge-to-edge repair (TEER) is now a well-established strategy in high-risk patients with MR. Globally, over 250,000 patients have benefited from the TEER technique.Studies have shown that patients with severe mitral regurgitation exhibit a high prevalence of atrial fibrillation (AF), reaching up to 63%, which is an indication for long-term oral anticoagulation (OAC) therapy. However, no dedicated study has prospectively evaluated different antithrombotic strategies following TEER in patients with an indication for OAC. Current guidelines do not provide any recommendations for the antithrombotic management of TEER. Consequently, considerable treatment variation exists in clinical studies and practice. The investigators will conduct a multicenter, open-label randomized trial to compare different antithrombotic strategies following TEER in patients who have an indication for OAC.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Active Comparator: Rivaroxaban+Clopidogrel and a drug called Experimental: Rivaroxaban monotherapy for people with mitral regurgitation. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGExperimental: Rivaroxaban monotherapy

Rivaroxaban monotherapy

DRUGActive Comparator: Rivaroxaban+Clopidogrel

Rivaroxaban+Clopidogrel


Locations(1)

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06901466


Related Trials