Clinical trial NCT06901466: STrategies for AntithRombotic Treatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Mitral Regurgitation
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
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 880
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Patients who had undergone successful TEER (Defined as techinal success according to MVARC );
* Need for long-term oral anticoagulation;
* Ability to understand the requirements of the trial and willingness to comply with the trial protocol procedures;
* Providing written informed consent form；
* Women of childbearing potential must use an acceptable method of contraception from signing the informed consent form until the date of the last dose of antithrombotic drug;
* The heart team agrees on the antithrombotic strategies.

Exclusion Criteria:

* Severe renal impairment (creatinine clearance rate\<15ml/min or on dialysis)；
* Postoperative persistent bleeding (overt bleeding either associated with a drop in the hemoglobin of 3.0 g/dl or requiring transfusion of 3 U of whole blood or packed red blood cells) or occurrence of vascular complications；
* Platelet count ≤ 30 ×10\^9/L；
* Need for reoperation；
* History of intracranial or intracerebral hemorrhage；
* History of gastrointestinal ulcers or hemorrhage；
* Any hepatic disease associated with coagulopathy (Child-Pugh B or C);
* Allergy, intolerance or contraindication to oral anticoagulation or antiplatelet drug;
* History of cerebrovascular event or transient ischemic attack within the past 6 weeks;
* Current antiplatelet therapy；
* Patients who have participated in another drug or device investigational study within the past 30 days；
* Life expectancy \<12 months；
* Pregnant or breastfeeding women。

Primary outcomes:
measure: All bleeding complications at 1 year after TEER
timeFrame: 1 year
Secondary outcomes:
measure: Non-procedure-related bleeding complications at 1 year after TEER（key secondary outcome 1）
timeFrame: 1 year
measure: Composite of ischemic event (1)(key secondary outcome 2)
timeFrame: 1 year
measure: Composite of ischemic event (2)
timeFrame: 1 year
measure: Composite of ischemic and bleeding events（1）
timeFrame: 1 year
measure: Composite of ischemic and bleeding events（2）
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences, Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xiangbin Pan, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shouzheng Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: