Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Extended Registry
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- stent thrombosis
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating "on-treatment" platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).
IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on bleeding events and net clinical benefit
详细描述
Determination of platelet reactivity in patients with percutaneous coronary Intervention as described in the IDEAL-PCI registry.
In the IDEAL-PCI Extended Registry an additional deescalation arm with reduction of the standard dual antiplatelet therapy (DAPT) dosis in case of low platelet reactivity to P2Y12 Inhibition or Aspirin with or without bleeding is implemented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all consecutive PCI patients
排除标准
- •pregnancy
研究组 & 干预措施
Bleeding prevention group
Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor
干预措施: DAPT reduction (Drug)
Bleeding prevention group
Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor
干预措施: DAPT on-target (Drug)
Ischemia prevention group
Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor
干预措施: DAPT on-target (Drug)
Ischemia prevention group
Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor
干预措施: DAPT intensification (Drug)
结局指标
主要结局
stent thrombosis
时间窗: 1 year
stent thrombosis by any Academic Research Consortium (ARC) definition
bleeding
时间窗: 1 year
bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition
次要结局
- Major adverse cardiac and cerebrovascular Events (MACCE)(1 year)
研究者
Prof. Dr. Guenter Christ
Prof
Kaiser Franz Josef Hospital