STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-edge Repair in Patients Without 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
- 1,032
- 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. 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.
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.
- •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.
- •Indication for long-term OAC.
- •Absolute indication for dual antiplatelet therapy; (eg, recent PCI).
- •Life expectancy < 12 months.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Aspirin monotherapy
Participants will receive Aspirin monotherapy (100 mg once daily, minimum 12 months).
干预措施: Experimental: Aspirin monotherapy (Drug)
Aspirin + Clopicogrel
Participants will receive Aspirin (100 mg once daily, minimum 12 months) plus clopidogrel (75 mg once daily for 3 months).
干预措施: Active Comparator: Aspirin+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
- 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（1）(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