STrategies for AntithRombotic Treatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant (STAR-TEER Ⅱ)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Mitral Regurgitation

Treatments: Drug: Experimental: Aspirin monotherapy; Drug: Active Comparator: Aspirin+Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT07007143

2024-2499

Details and patient eligibility

About

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.

Enrollment: 1,032 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who had undergone successful TEER (Defined as techinal success according to MVARC );
• Ability to understand the requirements of the trial and willingness to comply with the trial protocol procedures;
• Provide written informed consent form；
• Women of childbearing potential must use an acceptable method of contraception from signing the informed consent form until the date of the last dose of antithrombotic drug;
• The heart team agrees on the antithrombotic strategies.

Exclusion criteria

• Severe renal impairment (creatinine clearance rate<15ml/min or on dialysis);
• Postoperative persistent bleeding (overt bleeding either associated with a drop in the hemoglobin of 3.0 g/dl or requiring transfusion of 3 U of whole blood or packed red blood cells) or occurrence of vascular complications;
• Platelet count≤30×10^9/L;
• Need for reoperation;
• History of intracranial or intracerebral hemorrhage;
• History of gastrointestinal ulcers or hemorrhage;
• Any hepatic disease associated with coagulopathy (Child-Pugh B or C);
• Allergy, intolerance or contraindication to oral anticoagulation or antiplatelet drug;
• Need for long-term oral anticoagulation;
• Current double antiplatelet therapy；
• Patients who have participated in another drug or device investigational study within the past 30 days;
• Life expectancy <12 months;
• Pregnant or breastfeeding women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,032 participants in 2 patient groups

Aspirin monotherapy

Experimental group

Description:

Participants will receive aspirin (100mg qd) within 12 months after the TEER. For patients using aspirin at baseline, aspirin is intended to be continued during perioperative period.In patients are already treated with clopidogrel, we recommend patients to be switched to aspirin at least 5 days prior to TEER because of the pharmacokinetics of clopidogrel.

Treatment:

Drug: Experimental: Aspirin monotherapy

Aspirin + Clopicogrel

Active Comparator group

Description:

Participants will receive clopidogrel (75mg qd, 3 months) on top of aspirin (100mg qd, 12months).For patients using aspirin at baseline, aspirin is intended to be continued during perioperative period.In patients are already treated with clopidogrel, we recommend patients to be switched to aspirin at least 5 days prior to TEER because of the pharmacokinetics of clopidogrel.

Treatment:

Drug: Active Comparator: Aspirin+Clopidogrel