Mitral RegurgitationPhase 4STAR-TEER ⅠNCT06901466
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant
A Phase 4 study testing Experimental: Rivaroxaban monotherapy and Active Comparator: Rivaroxaban+Clopidogrel in people with Mitral Regurgitation, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Experimental: Rivaroxaban monotherapy and Active Comparator: Rivaroxaban+Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2025to 31 Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, 100037
Xiangbin Pan, MD,PhD, 86(10)88396666, panxiangbin@fuwaihospital.org
Xiangbin Pan, MD,PhD
About this study
Official title: 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.
- Conditions
- Mitral Regurgitation
- Being tested
- Experimental: Rivaroxaban monotherapy, Active Comparator: Rivaroxaban+Clopidogrel
- Keywords
- Transcatheter Edge-to-Edge Repair (TEER), Mitral Regurgitation, Cardiovascular Diseases, Embolism and Thrombosis, Bleeding, Aspirin, Rivaroxaban, Antithrombotic treatment, Oral anticoagulation, Platelet Aggregation Inhibitors, Stroke, Myocardial Infarction
- Medical subject headings
- Mitral Valve Insufficiency, Cardiovascular Diseases, Embolism and Thrombosis, Hemorrhage, Stroke, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Rivaroxaban monotherapyDrug
Rivaroxaban monotherapy
Active Comparator: Rivaroxaban+ClopidogrelDrug
Rivaroxaban+Clopidogrel
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Active Comparator: Rivaroxaban+Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 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
Measured: 1 year
Composite of ischemic event (2)
Composite of cardiovascular mortality, ischemic stroke, systemic embolic events ,or myocardial infarction at 1 year after TEER.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start13 Jun 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiangbin Pan, MD,PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai HospitalShouzheng Wang, MD,PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901466
- Sponsor's protocol ID
- 2025-2612
- Acronym
- STAR-TEER Ⅰ
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41616808
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-edge Repair in Patients With an Indication for Oral Anticoagulant: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06901466
- Acronym / sponsor ID
- STAR-TEER Ⅰ / 2025-2612
- Conditions
- Mitral Regurgitation
- Keywords
- Transcatheter Edge-to-Edge Repair (TEER), Mitral Regurgitation, Cardiovascular Diseases, Embolism and Thrombosis, Bleeding, Aspirin, Rivaroxaban, Antithrombotic treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban monotherapy | Experimental | Drug: Experimental: Rivaroxaban monotherapyParticipants 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. |
| Rivaroxaban + clopidogrel | Active comparator | Drug: Active Comparator: Rivaroxaban+ClopidogrelParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Rivaroxaban monotherapyRivaroxaban monotherapy | Drug | Rivaroxaban monotherapy |
| Active Comparator: Rivaroxaban+ClopidogrelRivaroxaban+Clopidogrel | Drug | Rivaroxaban + clopidogrel |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Derived from this study: PubMed 41616808Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiangbin Pan, MD,PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
Shouzheng Wang, MD,PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental: Rivaroxaban monotherapy and Active Comparator: Rivaroxaban+Clopidogrel in people with Mitral Regurgitation, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangbin Pan, MD,PhD (+86(10)88396666, panxiangbin@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All bleeding complications at 1 year after TEER (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06901466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.