Trials / Recruiting
RecruitingNCT06901466
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
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 880 (estimated)
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Experimental: Rivaroxaban monotherapy | Rivaroxaban monotherapy |
| DRUG | Active Comparator: Rivaroxaban+Clopidogrel | Rivaroxaban+Clopidogrel |
Timeline
- Start date
- 2025-06-13
- Primary completion
- 2027-10-31
- Completion
- 2028-10-31
- First posted
- 2025-03-30
- Last updated
- 2026-03-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06901466. Inclusion in this directory is not an endorsement.