Antithrombotic approaches after transcatheter edge-to-edge repair for mitral regurgitation
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-edge Repair in Patients Without an Indication for Oral Anticoagulant: a Multicenter Randomized Controlled Trial
This test compares aspirin alone versus aspirin plus clopidogrel to see which is safer and more effective at preventing clots and bleeding after TEER in people with mitral regurgitation who do not need oral anticoagulants.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1032 (estimated) |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07007143 on ClinicalTrials.gov |
What this trial studies
This is a phase 4, open-label, randomized trial comparing two antiplatelet strategies after successful transcatheter edge-to-edge repair (TEER) in patients without an indication for oral anticoagulation. Eligible patients who have had technically successful TEER will be randomized to receive either aspirin monotherapy or aspirin plus clopidogrel. Participants will be followed for thrombotic and bleeding events as well as other safety outcomes to determine which regimen offers the best balance of efficacy and safety. The trial is organized by investigators at major cardiovascular centers including Fuwai Hospital in Beijing.
Who should consider this trial
Good fit: Ideal candidates are adults who underwent a technically successful TEER for mitral regurgitation and have no current indication for oral anticoagulant therapy.
Not a fit: Patients who need oral anticoagulation, have severe renal impairment, active postoperative bleeding or vascular complications, very low platelets, recent major intracranial or gastrointestinal bleeding, or require reoperation are unlikely to benefit from randomization in this trial.
Why it matters
Potential benefit: If successful, the trial could simplify and standardize antithrombotic care after TEER, potentially reducing bleeding without raising clot risk.
How similar studies have performed: Dedicated prospective randomized trials comparing antithrombotic regimens after TEER are largely lacking, so this approach is relatively untested in this specific population though antiplatelet strategies have mixed evidence in other transcatheter procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Successful TEER procedure, defined as technical success per MVARC criteria. * 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. * Indication for long-term OAC. * Absolute indication for dual 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.