STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental: Aspirin monotherapy, Active Comparator: Aspirin+Clopidogrel.
- Who it may be relevant to
- Registry conditions: Mitral Regurgitation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-edge Repair in Patients Without an Indication for Oral Anticoagulant: a Multicenter Randomized Controlled Trial
Overview
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. However, no dedicated study has prospectively evaluated different antithrombotic strategies following TEER in patients undergone TEER procedure. 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 without an indication for OAC.
Interventions
- Drug Experimental: Aspirin monotherapy
Aspirin monotherapy - Drug Active Comparator: Aspirin+Clopidogrel
Aspirin+Clopidogrel
Primary outcome measures
- All bleeding complications at 1 year after TEER [Time frame: 1 year]
Secondary outcome measures (5)
- Non-procedure-related bleeding complications at 1 year after TEER（key secondary outcome 1） [Time frame: 1 year]
- Composite of ischemic event (1)(key secondary outcome 2) [Time frame: 1 year]
- Composite of ischemic event (2) [Time frame: 1 year]
- Composite of ischemic and bleeding events（1） [Time frame: 1 year]
- Composite of ischemic and bleeding events（2） [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Successful TEER procedure, defined as technical success per MVARC criteria.
- 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.
- Indication for long-term OAC.
- Absolute indication for dual antiplatelet therapy; (eg, recent PCI).
- Life expectancy < 12 months.
- Pregnancy or breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese Academy of Medical Sciences, Fuwai Hospital — Beijing
Publications
- Wang C, Liu Z, Li Z, Yan X, Wang C, Zhou N, Zhang F, Ouyang W, Zhao G, Ma J, Wang S, Pan X. STrategies for antithrombotic tRreatment following transcatheter edge-to-edge repair in patients with severe mitral regurgitation: Rationale and design of STAR-TEER trial. Am Heart J. 2026 Jun;296:107362. doi: 10.1016/j.ahj.2026.107362. Epub 2026 Jan 28. PMID 41616808
Identifiers
NCT: NCT07007143 · 2024-2499