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

Study acronym: STAR-TEER Ⅰ
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date changed from estimate of May 1, 2025 to Jun 13, 2025
    • Interventions: Active Comparator: Rivaroxaban+Aspirin (Drug), Experimental: Rivaroxaban monotherapy (Drug) to Active Comparator: Rivaroxaban+Clopidogrel (Drug), Experimental: Rivaroxaban monotherapy (Drug)
    • Eligibility criteria shortened, about 12 words
    • Site details revised
  2. Enrollment target: 1912 to 880v2 Show 10 more changesShow less
    • Primary completion date: Apr 1, 2029 to Oct 31, 2027
    • Start date: Apr 1, 2025 to May 1, 2025
    • Study completion date: Apr 1, 2029 to Oct 31, 2028
    • Interventions: Active Comparator: Aspirin+Clopidogrel (Cohort B) (Drug), Active Comparator: Rivaroxaban+Aspirin (Cohort A) (Drug), Experimental: Aspirin… to Active Comparator: Rivaroxaban+Aspirin (Drug), Experimental: Rivaroxaban monotherapy (Drug)
    • Eligibility criteria shortened, about 178 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site contact updated
    • Study arms: 4 to 2
    • Collaborators shortened, about 4 words
    • Study title shortened, about 3 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06901466
Lead Sponsor Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions
(from sponsor)		 Mitral Regurgitation
Related terms Cardiovascular Diseases, Embolism and Thrombosis, Hemorrhage, Mitral Valve Insufficiency, Myocardial Infarction, Stroke
Enrollment 880 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov