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RECRUITING
NCT06901466
PHASE4

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

Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

880

Start Date

2025-06-13

Completion Date

2028-10-31

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DRUG

Experimental: Rivaroxaban monotherapy

Rivaroxaban monotherapy

DRUG

Active Comparator: Rivaroxaban+Clopidogrel

Rivaroxaban+Clopidogrel

Locations (1)

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, China