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

Launched by CHINESE ACADEMY OF MEDICAL SCIENCES, FUWAI HOSPITAL · Mar 23, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to explore the best ways to manage blood-thinning medication (antithrombotic therapy) for patients who have undergone a procedure called transcatheter edge-to-edge repair (TEER) to fix a heart valve problem known as mitral regurgitation. This condition affects how the heart pumps blood and is quite common, especially in older adults. The study aims to compare different medication strategies for patients who have had successful TEER, helping to improve future treatment guidelines since there hasn't been a dedicated study on this topic before.

To participate in the trial, patients must have successfully completed the TEER procedure. Depending on their specific needs, they will be placed in one of two groups: one group requires long-term blood-thinning medication, while the other does not. Participants will need to understand the trial requirements, agree to follow the study protocol, and provide written consent. Throughout the trial, patients can expect careful monitoring and support as researchers gather important information to help improve treatment options for others in the future.

Gender

ALL

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。