STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant (STAR-TEER Ⅰ)

STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-edge Repair in Patients With an Indication for Oral Anticoagulant: a Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Drug: Experimental: Rivaroxaban monotherapy; Drug: Active Comparator: Rivaroxaban+Clopidogrel

• Study Type: Interventional
• Enrollment (Estimated): 880
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiangbin Pan, MD,PhD; Phone Number: +86(10)88396666; Email: panxiangbin@fuwaihospital.org
• Study Contact Backup: Name: Zizheng Liu, M.B; Phone Number: +86(10)88396666; Email: liuzizheng00@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Recruiting
      • Chinese Academy of Medical Sciences, Fuwai Hospital
      • Contact: Xiangbin Pan, MD,PhD; Phone Number: 86(10)88396666; Email: panxiangbin@fuwaihospital.org
      • Principal Investigator: Xiangbin Pan, MD,PhD
      • Principal Investigator: Shouzheng Wang, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rivaroxaban monotherapy; Participants will receive rivaroxaban monotherapy (20 mg once daily, minimum 12 months). The dosage of rivaroxaban can be adjusted by the research physicians according to the patients' clinical conditions, following the package insert.	Drug: Experimental: Rivaroxaban monotherapy; Rivaroxaban monotherapy
Active Comparator: Rivaroxaban + clopidogrel; Participants will receive rivaroxaban (20 mg once daily, minimum 12 months) plus clopidogrel (75 mg once daily for 3 months). The dosage of rivaroxaban can be adjusted by the research physicians according to the patients' clinical conditions, following the package insert.	Drug: Active Comparator: Rivaroxaban+Clopidogrel; Rivaroxaban+Clopidogrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-procedure-related bleeding complications at 1 year after TEER（key secondary outcome 1）	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.	1 year
Composite of ischemic event (1)(key secondary outcome 2)	composite of all-cause mortality, stroke, systemic embolic events , or myocardial infarction at 1 year after TEER	1 year
Composite of ischemic event (2)	Composite of cardiovascular mortality, ischemic stroke, systemic embolic events ,or myocardial infarction at 1 year after TEER.	1 year
Composite of ischemic and bleeding events（2）	Composite of non-procedure-related bleeding events, cardiovascular mortality, ischemic stroke, systemic embolic events or myocardial infarction at 1 year after TEER.	1 year
Composite of ischemic and bleeding events（1）	Composite of all bleeding, all-cause mortality, stroke, systemic embolic events or myocardial infarction at 1 year after TEER.	1 year

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Collaborators: Beijing Municipal Health Commission
• Investigators: Principal Investigator: Xiangbin Pan, MD,PhD, Chinese Academy of Medical Sciences, Fuwai Hospital; Principal Investigator: Shouzheng Wang, MD,PhD, Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

General 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 Jan 28;296:107362. doi: 10.1016/j.ahj.2026.107362. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: March 23, 2025
• First Submitted That Met QC Criteria: March 23, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Aspirin; Stroke; Rivaroxaban; Cardiovascular Diseases; Bleeding; Mitral Regurgitation; Myocardial Infarction; Platelet Aggregation Inhibitors; Oral anticoagulation; Embolism and Thrombosis; Antithrombotic treatment; Transcatheter Edge-to-Edge Repair (TEER)
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Heart Valve Diseases; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Stroke; Cardiovascular Diseases; Hemorrhage; Myocardial Infarction; Mitral Valve Insufficiency; Embolism and Thrombosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Protease Inhibitors; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Anticoagulants; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Rivaroxaban; Aspirin
• Other Study ID Numbers: 2025-2612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No