Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Rivaroxaban monotherapy | Drug | Rivaroxaban monotherapy |
| |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangbin Pan, MD,PhD | Contact | +86(10)88396666 | panxiangbin@fuwaihospital.org | |
| Zizheng Liu, M.B | Contact | +86(10)88396666 | liuzizheng00@126.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | Recruiting | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41616808 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Active Comparator: Rivaroxaban+Clopidogrel |
| Drug |
Rivaroxaban+Clopidogrel |
|
| 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（1） | Composite of all bleeding, all-cause mortality, 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 |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D002318 | Cardiovascular Diseases |
| D016769 | Embolism and Thrombosis |
| D006470 | Hemorrhage |
| D020521 | Stroke |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D017202 | Myocardial Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
Not provided
Not provided