drugset / Trial / NCT07007143

STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant

NCT07007143 ↗

Phase 4 Recruiting 1032 enrolled Chinese Academy of Medical Sciences, Fuwai Hospital
RandomizedParallel-groupOpen-labelTreatment

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. However, no dedicated study has prospectively evaluated different antithrombotic strategies following TEER in patients undergone TEER procedure. 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 without an indication for OAC.

Timeline

Start
2025-07-31
Primary completion
2028-09-30
Completion
2029-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 100 mg —
Comparator Clopidogrel Small molecule 75 mg —