STrategies for AntithRombotic Treatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant

Launched by CHINESE ACADEMY OF MEDICAL SCIENCES, FUWAI HOSPITAL · May 28, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Strategies for Antithrombotic Treatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant," is focused on finding the best blood-thinning treatment for patients who have undergone a specific heart procedure called transcatheter edge-to-edge repair (TEER) for mitral regurgitation (MR). Mitral regurgitation is a common heart condition that affects many older adults. The study aims to compare different strategies for managing blood thinners after the TEER procedure, as current guidelines do not provide clear recommendations, leading to varying practices.

To participate in this trial, patients must have successfully undergone the TEER procedure and be able to understand and agree to the study requirements. Some key exclusions include individuals with severe kidney issues, significant bleeding problems, or those who need long-term blood thinners. Participants can expect close monitoring and guidance from medical professionals throughout the study. This research is important as it aims to improve post-procedure care for patients, ensuring they receive the most effective and safe treatment options.

Gender

ALL

Eligibility criteria

• 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.