NCT06901466 STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant
| NCT ID | NCT06901466 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital |
| Condition | Mitral Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 880 participants |
| Start Date | 2025-06-13 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 880 participants in total. It began in 2025-06-13 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Successful TEER procedure, defined as technical success per MVARC criteria. * Indication for long-term OAC. * Ability and willingness to comply with the trial protocol. * Provision of written informed consent. * Women of childbearing potential must use effective contraception from the time of consent until the final dose of antithrombotic therapy. * Antithrombotic strategy approved by the investigator. Exclusion Criteria: * Severe renal impairment (creatinine clearance \< 15 mL/min or requiring dialysis). * Ongoing postoperative bleeding (defined as overt bleeding with a ≥3.0 g/dL drop in hemoglobin or requiring ≥3 units of blood transfusion), or vascular complications following the index TEER procedure. * Platelet count \< 50 × 10\^9 /L. * Need for reoperation due to complications of the index TEER procedure. * Recent ( \< 12 month) intracranial or intracerebral hemorrhage. * Recent ( \< 12 month) gastrointestinal ulcers or hemorrhage. * Hepatic disease with coagulopathy.(eg, Child-Pugh class B or C cirrhosis). * Allergy, intolerance, or contraindication to research drugs. * Participation in another investigational drug or device study within 30 days. * History of stroke or TIA within the past 6 weeks. * Absolute indication for anticoagulation in combination with antiplatelet therapy (eg, recent PCI). * Life expectancy \< 12 months. * Pregnancy or breastfeeding.
Contact & Investigator
Xiangbin Pan, MD,PhD
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Frequently Asked Questions
Who can join the NCT06901466 clinical trial?
This trial is open to participants of all sexes, studying Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06901466 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06901466 currently recruiting?
Yes, NCT06901466 is actively recruiting participants. Contact the research team at panxiangbin@fuwaihospital.org for enrollment information.
Where is the NCT06901466 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06901466 clinical trial?
NCT06901466 is sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. The principal investigator is Xiangbin Pan, MD,PhD at Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 880 participants.