NCT06901466

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.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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
880

participants targeted

Target at P75+ for phase_4

Timeline
30mo left

Started Jun 2025

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Jun 2025Oct 2028

First Submitted

Initial submission to the registry

March 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 13, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2028

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

March 23, 2025

Last Update Submit

March 5, 2026

Conditions

Mitral Regurgitation

Keywords

Transcatheter Edge-to-Edge Repair (TEER)Mitral RegurgitationCardiovascular DiseasesEmbolism and ThrombosisBleedingAspirinRivaroxabanAntithrombotic treatmentOral anticoagulationPlatelet Aggregation InhibitorsStrokeMyocardial Infarction

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)

Rivaroxaban monotherapy

EXPERIMENTAL

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 + clopidogrel

ACTIVE COMPARATOR

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

Interventions

Experimental: Rivaroxaban monotherapyDRUG

Rivaroxaban monotherapy

Rivaroxaban monotherapy
Active Comparator: Rivaroxaban+ClopidogrelDRUG

Rivaroxaban+Clopidogrel

Rivaroxaban + clopidogrel

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

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

Mitral Valve InsufficiencyCardiovascular DiseasesEmbolism and ThrombosisHemorrhageStrokeMyocardial Infarction

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMyocardial IschemiaInfarctionIschemiaNecrosis

Study Officials

  • Xiangbin Pan, MD,PhD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

  • Shouzheng Wang, MD,PhD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangbin Pan, MD,PhD

CONTACT

+86(10)88396666panxiangbin@fuwaihospital.org

Zizheng Liu, M.B

CONTACT

+86(10)88396666liuzizheng00@126.com

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

March 23, 2025

First Posted

March 30, 2025

Study Start

June 13, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2028

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)