STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChinese Academy of Medical Sciences, Fuwai Hospital

About this trial

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. However, no dedicated study has prospectively evaluated different antithrombotic strategies following TEER in patients undergone TEER procedure. 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 without an indication for OAC.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Experimental: Aspirin monotherapy
  • Active Comparator: Aspirin+Clopidogrel

Treatment groups

1,032 Participants
are divided into 2 treatment groups