Antithrombotic approaches after transcatheter edge-to-edge repair for mitral regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.