Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,016
- 试验地点
- 17
- 主要终点
- Safety endpoint
研究概览
简要总结
At present, a variety of antithrombotic regimens are prescribed in the early postprocedure period after transcatheter aortic valve implantation (TAVI). Dual antiplatelet therapy (DAPT) using aspirin and a thienopyridine in the initial period after TAVI is the recommended strategy; however, mono antiplatelet therapy using aspirin is suggested not to be inferior. In patients with atrial fibrillation (AF) or another indication for oral anticoagulation (OAC), no recommendations on best treatment regimen currently exist although triple therapy (OAC + DAPT) is best avoided due to increased bleeding risk.
We hypothesise that the omission of clopidogrel in the first 3 months after TAVI is safer and not less beneficial than the addition of clopidogrel to aspirin (cohort A) or OAC (cohort B).
详细描述
The trial consists of two cohorts:
- Cohort A, patients without an indication for OAC prior to TAVI.
- Cohort B, patients with an indication for OAC prior to TAVI (eg. atrial fibrillation, mechanic mitral valve prosthesis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has provided written informed consent.
- •Need for long-term oral anticoagulation;
- •Patient has provided written informed consent.
排除标准
- •Need for long-term oral anticoagulation;
- •Drug-eluting stent implantation within 3 months prior to TAVI procedure;
- •Bare-metal stent implantation within 1 month prior to TAVI procedure;
- •Allergy or intolerance to aspirin or clopidogrel.
- •Drug-eluting stent implantation within 3 months prior to TAVI procedure;
- •Bare-metal stent implantation within 1 month prior to TAVI procedure;
- •Allergy or intolerance to (N)OAC or clopidogrel.
研究组 & 干预措施
Aspirin + Clopicogrel (Cohort A)
Cohort A: patients will receive clopidogrel (75mg quaque die (qD), 3 months) on top of low-dose aspirin (≤100mg qD, at least 1 year but recommended lifelong). When a patient in Cohort A doesn't already takes aspirin, a loading dose of 300mg will be given within 24 hours prior to TAVI. The loading dose for clopidogrel is 300mg, and will be given within 24 hours prior to TAVI.
干预措施: Aspirin + clopidogrel (Drug)
Aspirin monotherapy (Cohort A)
Cohort A: patients will receive low-dose aspirin (≤100mg qD, at least 1 year but recommended lifelong). When a patients doesn't already takes aspirin, a loading dose of 300mg will be given within 24 hours prior to TAVI. It is recommended to omit other antiplatelet therapy (e.g. clopidogrel) at least 5 days prior to the TAVI procedure.
干预措施: Aspirin monotherapy (Drug)
OAC + Clopicogrel (Cohort B)
Cohort B: patients will receive clopidogrel (75mg qD, 3 months) on top of OAC (according to its indication). The loading dose for clopidogrel is 300mg, and will be given within 24 hours prior to TAVI. It is recommended to omit other antiplatelet therapy (e.g. aspirin) at least 5 days prior to the TAVI procedure.
干预措施: OAC + clopicogrel (Drug)
OAC monotherapy (Cohort B)
Cohort B: patients will receive OAC according to its indication. It is recommended to continue the OAC therapy peri-procedural (International Normalized Ratio aimed at 2.0). It is recommended to omit antiplatelet therapy (e.g. clopidogrel) at least 5 days prior to the TAVI procedure.
干预措施: OAC monotherapy (Drug)
结局指标
主要结局
Safety endpoint
时间窗: 1 year
The primary outcome is a safety endpoint, defined as freedom of all bleeding complications at 1 year after TAVI. The co-primary outcome is the safety endpoint defined as freedom of non-procedure related bleeding complications at 1 year after TAVI. For the classification of bleeding complications the Bleeding Academic Research Consortium Definition for Bleeding (BARC) bleeding classification is primarily used according to the Valve Academic Research Consortium (VARC).
次要结局
- Net-clinical benefit endpoint(1 year)
- Efficacy endpoint(1 year)
研究者
J.M. ten Berg
Prof. Dr.
St. Antonius Hospital