Status:
NOT_YET_RECRUITING
STrategies for AntithRombotic Treatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
Phase:
PHASE4
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 re...
Eligibility Criteria
Inclusion
- 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
- 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。
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
880 Patients enrolled
Trial Details
Trial ID
NCT06901466
Start Date
May 1 2025
End Date
October 31 2028
Last Update
April 27 2025
Active Locations (1)
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1
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, China, 100037