Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,008
- 试验地点
- 1
- 主要终点
- Definite 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).
详细描述
Depending on the clinical presentation patients are treated according to standard operating procedures in our department. The earliest, 12 hours after an initial clopidogrel-loading dose (600mg)"on-treatment" platelet reactivity will be determined by Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer), a point of care assay. In case of high residual platelet reactivity (i.e. ≥ 50U), patients are switched according to a therapeutic algorithm to either prasugrel (Efient®), or in case of contraindication (i.e. stroke) to ticagrelor (Brilique®), or in case of contraindication (intracranial hemorrhage) reloaded with clopidogrel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •all consecutive PCI patients with stent implantation of our institution
排除标准
- •pregnancy
研究组 & 干预措施
standard therapy
standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
干预措施: Clopidogrel (Drug)
individualized therapy
dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
干预措施: prasugrel or ticagrelor (Drug)
结局指标
主要结局
Definite Stent Thrombosis
时间窗: 30 days
The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis"
Any Bleeding Event
时间窗: 30days
Bleeding classified by the TIMI hemorrhage classification scheme: Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to \< 5 g/dL Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of \> 5 g/dL
次要结局
- Probable Stent Thrombosis(30days)
研究者
Prof. Dr. Guenter Christ
Univ. Prof. Dr.
Kaiser Franz Josef Hospital