Prospective, Randomized Study of the Platelet Inhibitory Efficacy of Ticagrelor Versus Prasugrel in Clopidogrel Low Responders After Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel
研究概览
简要总结
Clopidogrel low response is associated with a significantly higher risk for ischemic complications after percutaneous coronary intervention. Ticagrelor and prasugrel are more potent platelet inhibitory drugs and both have been shown to significantly reduce ischemic events as compared to clopidogrel. No direct comparison between ticagrelor and prasugrel in terms of their antiplatelet efficacy exists. The aim of this study is to assess the antiplatelet treatment efficacy of ticagrelor versus prasugrel over time in confirmed clopidogrel low responders undergoing percutaneous coronary intervention.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •successful PCI
- •600 mg clopidogrel pretreatment
- •clopidogrel low response assessed with electrode aggregometry (>= 486 AU*min)
- •written informed consent
排除标准
- •Contraindications or allergies against study drugs
- •Any surgery < 6 weeks
- •Increased bleeding risk
- •Oral anticoagulation
- •platelet count < 100.000/µl
- •Prior history of stroke or pathologic intracranial findings
- •GPIIb/IIIa antagonists < 10 days or periprocedural
- •Age > 80 years, < 18 years
- •Body weight < 60 kg
- •Cardiogenic shock
- •Increased risk of bradycardia
- •Moderate liver disease
- •Kidney dialysis
- •Intake of CYP 3A4 inhibitors
- •Pregnancy or lactation
- •Missing pregnancy test for women capable of bearing children
研究组 & 干预措施
Prasugrel
A prasugrel loading dose of 60 mg is administered followed by a 10 mg per day maintenance dose for patients < 75 years or a 5 mg maintenance dose per day for patients >= 75 years
干预措施: Prasugrel (Drug)
Ticagrelor
A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily
干预措施: Ticagrelor (Drug)
结局指标
主要结局
ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel
时间窗: Day 2 post randomization
次要结局
- Proportion of low responders in ticagrelor or prasugrel group(Day 2 post randomization)
- Proportion of enhanced responders in ticagrelor or prasugrel group(Day 2 post randomization)