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NCT Number: NCT07007143

STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant

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.

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Key information

Conditions

Mitral Regurgitation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Heart Diseases Heart Valve Diseases Hemorrhage Infarction Ischemia Mitral Valve Insufficiency Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Shouzheng Wang, MD,PhD

PRINCIPAL_INVESTIGATOR

Xiangbin Pan, MD,PhD

CONTACT

[email protected]

+861088396666

Xiangbin Pan, MD,PhD

PRINCIPAL_INVESTIGATOR

Zizheng Liu, M.B

CONTACT

[email protected]

+86(10)88396666

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental: Aspirin monotherapy

Drug

Aspirin monotherapy

Active Comparator: Aspirin+Clopidogrel

Drug

Aspirin+Clopidogrel

Primary outcomes

  1. All bleeding complications at 1 year after TEER

    Time frame: 1 year

    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.

Secondary outcomes

  1. Non-procedure-related bleeding complications at 1 year after TEER（key secondary outcome 1）

    Time frame: 1 year

    Non-procedure-related bleeding is consisted of all MVARC bleeding, excluding Bleeding Academic Research Consortium (BARC ) type 4 severe bleeding.BARC type 4 severe bleeding is defined by any of the following: perioperative intracranial bleeding within 48 hours, reoperation after closure of sternotomy for the purpose of controlling bleeding, transfusion of 5 or more units of whole blood or packed red cells within a 48-hour period, chest-tube output of 2 or more liters within a 24-hour period.

  2. Composite of ischemic event (1)(key secondary outcome 2)

    Time frame: 1 year

    composite of all-cause mortality, stroke, systemic embolic events , or myocardial infarction at 1 year after TEER

  3. Composite of ischemic event (2)

    Time frame: 1 year

    Composite of cardiovascular mortality, ischemic stroke, systemic embolic events ,or myocardial infarction at 1 year after TEER.

  4. Composite of ischemic and bleeding events（1）

    Time frame: 1 year

    Composite of all bleeding, all-cause mortality, stroke, systemic embolic events or myocardial infarction at 1 year after TEER.

  5. Composite of ischemic and bleeding events（2）

    Time frame: 1 year

    Composite of non-procedure-related bleeding events, cardiovascular mortality, ischemic stroke, systemic embolic events or myocardial infarction at 1 year after TEER.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangbin Pan, MD,PhD

CONTACT

[email protected]

+86(10)88396666

Zizheng Liu, M.B

CONTACT

[email protected]

+86(10)88396666

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-edge Repair in Patients Without an Indication for Oral Anticoagulant: a Multicenter Randomized Controlled Trial

Acronym: STAR-TEER Ⅱ

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jun 5, 2025
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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