NCT06901466RecruitingPhase 4
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-edge Repair in Patients With an Indication for Oral Anticoagulant: a Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 9 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 880 (estimated)
- First submitted
- 23 Mar 2025
- Start date
- 13 Jun 2025
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Diseases
- Coronary artery disease, Stroke
- NCT number
- NCT06901466
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 880
- From 13 Jun 2025 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another investigational drug or device study within 30 days.
- Absolute indication for anticoagulation in combination with antiplatelet therapy (eg, recent PCI).
Other illness
- 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.
- History of stroke or TIA within the past 6 weeks.
Lab values
- 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.
Other
- Need for reoperation due to complications of the index TEER procedure.
- Life expectancy \< 12 months.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.