Antithrombotic approaches after transcatheter edge-to-edge mitral repair for patients who need oral anticoagulants

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

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.

Why it matters

Who can join: the full rules

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 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.