STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-edge Repair in Patients With an Indication for Oral Anticoagulant: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 880
- 试验地点
- 1
- 主要终点
- All bleeding complications at 1 year after TEER
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Rivaroxaban monotherapy
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.
干预措施: Experimental: Rivaroxaban monotherapy (Drug)
Rivaroxaban + clopidogrel
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.
干预措施: Active Comparator: Rivaroxaban+Clopidogrel (Drug)
结局指标
主要结局
All bleeding complications at 1 year after TEER
时间窗: 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.
次要结局
- Composite of ischemic and bleeding events（1）(1 year)
- 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（2）(1 year)
研究者
Pan Xiangbin
Principal Investigator
Chinese Academy of Medical Sciences, Fuwai Hospital