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

Condition(s) studied

Investigational drug(s) / intervention(s)

Experimental: Rivaroxaban monotherapy: Rivaroxaban monotherapy

Active Comparator: Rivaroxaban+Clopidogrel: Rivaroxaban+Clopidogrel

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.

Eligibility

Primary outcome measure(s)

• All bleeding complications at 1 year after TEER — 1 year
  For the classification of bleeding complications, the Mitral Valve Academic Research Consortium (MVARC) Primary Bleeding Scale is used. All bleeding can be categorized into five types: minor bleeding, major bleeding, extensive bleeding, life-threatening bleeding, and fatal bleeding.

Trial sites (1)

More Chinese Academy of Medical Sciences, Fuwai Hospital trials in China

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