STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant
NCT07007143 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1032
Last updated 2026-03-09
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.
Conditions
- Mitral Regurgitation
Interventions
- DRUG
-
Experimental: Aspirin monotherapy
Aspirin monotherapy
- DRUG
-
Active Comparator: Aspirin+Clopidogrel
Aspirin+Clopidogrel
Sponsors & Collaborators
-
Chinese Academy of Medical Sciences, Fuwai Hospital
lead OTHER
Principal Investigators
-
Xiangbin Pan, MD,PhD · Chinese Academy of Medical Sciences, Fuwai Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-31
- Primary Completion
- 2028-09-30
- Completion
- 2029-09-30
Countries
- China
Study Locations
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