STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant
STAR-TEER Ⅱ
1 other identifier
interventional
1,032
1 country
1
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2025
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2025
CompletedFirst Posted
Study publicly available on registry
June 5, 2025
CompletedStudy Start
First participant enrolled
July 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2029
March 9, 2026
March 1, 2026
3.2 years
May 28, 2025
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All bleeding complications at 1 year after TEER
For the classification of bleeding complications, the Mitral Valve Academic Research Consortium (MVARC) Primary Bleeding Scale is used. All bleeding can be categorized into five types: minor bleeding, major bleeding, extensive bleeding, life-threatening bleeding, and fatal bleeding.
1 year
Secondary Outcomes (5)
Non-procedure-related bleeding complications at 1 year after TEER（key secondary outcome 1）
1 year
Composite of ischemic event (1)(key secondary outcome 2)
1 year
Composite of ischemic event (2)
1 year
Composite of ischemic and bleeding events（1）
1 year
Composite of ischemic and bleeding events（2）
1 year
Study Arms (2)
Aspirin monotherapy
EXPERIMENTALParticipants will receive Aspirin monotherapy (100 mg once daily, minimum 12 months).
Aspirin + Clopicogrel
ACTIVE COMPARATORParticipants will receive Aspirin (100 mg once daily, minimum 12 months) plus clopidogrel (75 mg once daily for 3 months).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
Related Publications (1)
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: 41616808DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiangbin Pan, MD,PhD
Chinese Academy of Medical Sciences, Fuwai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 28, 2025
First Posted
June 5, 2025
Study Start
July 31, 2025
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
September 30, 2029
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share