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

NCT06901466 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2026-03-09

No results posted yet for this study

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.

Conditions

  • Mitral Regurgitation

Interventions

DRUG

Experimental: Rivaroxaban monotherapy

Rivaroxaban monotherapy

DRUG

Active Comparator: Rivaroxaban+Clopidogrel

Rivaroxaban+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

  • Shouzheng Wang, 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
2025-06-13
Primary Completion
2027-10-31
Completion
2028-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06901466 on ClinicalTrials.gov