STrategies for AntithRombotic Treatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant

NCT ID: NCT06901466

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 880 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2028-10-31

Brief Summary

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.Studies have shown that patients with severe mitral regurgitation exhibit a high prevalence of atrial fibrillation (AF), reaching up to 63%, which is an indication for long-term oral anticoagulation (OAC) therapy. However, no dedicated study has prospectively evaluated different antithrombotic strategies following TEER in patients with an indication for OAC. 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 who have an indication for OAC.

Conditions

Mitral Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rivaroxaban monotherapy

Participants will receive rivaroxaban according to its indication within 12 months after the TEER. For patients using OAC at baseline, the OAC therapy is intended to be continued during perioperative period.

Group Type: EXPERIMENTAL

Experimental: Rivaroxaban monotherapy

Intervention Type: DRUG

Rivaroxaban monotherapy

Rivaroxaban + Aspirin

Participants will receive aspirin (100mg qd, 6 months) on top of rivaroxaban (according to its indication, 12months).For patients using OAC at baseline, the OAC therapy is intended to be continued during perioperative period.

Group Type: ACTIVE_COMPARATOR

Active Comparator: Rivaroxaban+Aspirin

Intervention Type: DRUG

Rivaroxaban+Aspirin

Interventions

Experimental: Rivaroxaban monotherapy

Rivaroxaban monotherapy

Intervention Type: DRUG

Active Comparator: Rivaroxaban+Aspirin

Rivaroxaban+Aspirin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who had undergone successful TEER (Defined as techinal success according to MVARC );
• Need for long-term oral anticoagulation;
• Ability to understand the requirements of the trial and willingness to comply with the trial protocol procedures;
• Providing 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;
• History of cerebrovascular event or transient ischemic attack within the past 6 weeks;
• Current 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。

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pan Xiangbin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiangbin Pan, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Shouzheng Wang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Xiangbin Pan, MD,PhD

Role: CONTACT

panxiangbin@fuwaihospital.org

+86(10)88396666

Zizheng Liu, M.B

Role: CONTACT

liuzizheng00@126.com

+86(10)88396666

Facility Contacts

Xiangbin Pan, MD,PhD

Role: primary

panxiangbin@fuwaihospital.org

86(10)88396666

Other Identifiers

2025-2612

Identifier Type: -

Identifier Source: org_study_id