Mitral Regurgitation
Conditions
Keywords
Transcatheter Edge-to-Edge Repair (TEER), Mitral Regurgitation, Cardiovascular Diseases, Embolism and Thrombosis, Bleeding, Aspirin, Clopidogrel, Antithrombotic treatment, Platelet Aggregation Inhibitors, Antiplatelet Drug, Single Antiplatelet Therapy（SAPT）, Double Antiplatelet Therapy（DAPT）, Stroke, Myocardial Infarction
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. 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.
Interventions
DRUGExperimental: Aspirin monotherapy
Aspirin monotherapy
DRUGActive Comparator: Aspirin+Clopidogrel
Aspirin+Clopidogrel
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All bleeding complications at 1 year after TEER | 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
| Measure | Time frame | Description |
|---|---|---|
| Non-procedure-related bleeding complications at 1 year after TEER（key secondary outcome 1） | 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. |
| Composite of ischemic event (1)(key secondary outcome 2) | 1 year | composite of all-cause mortality, stroke, systemic embolic events , or myocardial infarction at 1 year after TEER |
| Composite of ischemic event (2) | 1 year | Composite of cardiovascular mortality, ischemic stroke, systemic embolic events ,or myocardial infarction at 1 year after TEER. |
| Composite of ischemic and bleeding events（1） | 1 year | Composite of all bleeding, all-cause mortality, stroke, systemic embolic events or myocardial infarction at 1 year after TEER. |
| Composite of ischemic and bleeding events（2） | 1 year | Composite of non-procedure-related bleeding events, cardiovascular mortality, ischemic stroke, systemic embolic events or myocardial infarction at 1 year after TEER. |
Countries
China
Contacts
CONTACTXiangbin Pan, MD,PhD
CONTACTZizheng Liu, M.B
PRINCIPAL_INVESTIGATORXiangbin Pan, MD,PhD
Chinese Academy of Medical Sciences, Fuwai Hospital
Outcome results
None listed