Antithrombotic approaches after transcatheter edge-to-edge mitral repair for patients who need oral anticoagulants
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-edge Repair in Patients With an Indication for Oral Anticoagulant: a Multicenter Randomized Controlled Trial
This trial will test whether rivaroxaban alone or rivaroxaban plus clopidogrel better prevents clots and bleeding after TEER in people who need long-term oral anticoagulation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 880 (estimated) |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06901466 on ClinicalTrials.gov |
What this trial studies
Patients with successful transcatheter edge-to-edge mitral repair and an indication for long-term oral anticoagulation are randomized in an open-label design to receive either rivaroxaban alone or rivaroxaban plus clopidogrel. The study compares thromboembolic and bleeding outcomes between the two antithrombotic strategies during post-procedural follow-up. Major exclusion criteria include severe renal impairment, recent intracranial or major gastrointestinal bleeding, very low platelet counts, and the need for reoperation after the index procedure. The protocol uses standard clinical endpoints for antithrombotic trials and is conducted under the leadership of Fuwai Hospital.
Who should consider this trial
Good fit: Adults who had a technically successful TEER, have an indication for long-term oral anticoagulation, can give informed consent, and meet the trial's safety criteria are ideal candidates.
Not a fit: Patients with severe renal failure, recent major intracranial or gastrointestinal bleeding, very low platelet counts, active postoperative bleeding, or who require reoperation are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the results could reduce bleeding complications and simplify antithrombotic management while maintaining protection against clots after TEER.
How similar studies have performed: No dedicated prospective randomized trials have specifically compared antithrombotic regimens after TEER in patients requiring oral anticoagulation, making this a novel comparison in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Successful TEER procedure, defined as technical success per MVARC criteria. * Indication for long-term OAC. * Ability and willingness to comply with the trial protocol. * Provision of written informed consent. * Women of childbearing potential must use effective contraception from the time of consent until the final dose of antithrombotic therapy. * Antithrombotic strategy approved by the investigator. Exclusion Criteria: * Severe renal impairment (creatinine clearance \< 15 mL/min or requiring dialysis). * Ongoing postoperative bleeding (defined as overt bleeding with a ≥3.0 g/dL drop in hemoglobin or requiring ≥3 units of blood transfusion), or vascular complications following the index TEER procedure. * Platelet count \< 50 × 10\^9 /L. * Need for reoperation due to complications of the index TEER procedure. * Recent ( \< 12 month) intracranial or intracerebral hemorrhage. * Recent ( \< 12 month) gastrointestinal ulcers or hemorrhage. * Hepatic disease with coagulopathy.(eg, Child-Pugh class B or C cirrhosis). * Allergy, intolerance, or contraindication to research drugs. * Participation in another investigational drug or device study within 30 days. * History of stroke or TIA within the past 6 weeks. * Absolute indication for anticoagulation in combination with antiplatelet therapy (eg, recent PCI). * Life expectancy \< 12 months. * Pregnancy or breastfeeding.
Where this trial is running
Beijing, Beijing Municipality
- Chinese Academy of Medical Sciences, Fuwai Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Xiangbin Pan, MD,PhD — Chinese Academy of Medical Sciences, Fuwai Hospital
- Study coordinator: Xiangbin Pan, MD,PhD
- Email: panxiangbin@fuwaihospital.org
- Phone: +86(10)88396666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.