Impact of Prasugrel Re-load on Platelet Aggregation in Patients on Chronic Prasugrel Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- PRI Levels at 4 Hours
研究概览
简要总结
A higher degree of platelet inhibition remains the goal of peri-interventional and long-term anti-thrombotic therapy in patients with coronary artery disease. In clinical practice, patients undergoing percutaneous coronary intervention with stent implantation who are already on clopidogrel therapy get re-loaded with clopidogrel. This is based on prior observations showing that higher inhibition of platelet aggregation may be achieved by giving a loading dose of clopidogrel in patients with coronary artery disease while on chronic clopidogrel therapy. However, to date it is unknown if greater inhibition of platelet aggregation can be achieved by adding a prasugrel loading dose in patients on chronic prasugrel therapy. Therefore, understanding the pharmacodynamic implications of a prasugrel re-load strategy in patients on already on chronic prasugrel therapy will be useful.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with angiographically documented coronary artery disease.
- •Age between 18 to 74 years
- •On treatment with prasugrel 10mg/daily for at least 14 days.
排除标准
- •Blood dyscrasias or bleeding diathesis
- •Antiplatelet treatment with clopidogrel or ticlopidine
- •Recent antiplatelet treatment (< 14 days) with a glycoprotein IIb/IIIa antagonist
- •Platelet count <100x106/µL
- •Active bleeding or hemodynamic instability.
- •Unstable angina, acute or recent (<14 days) myocardial infarction.
- •Serum creatinine >2 mg/dL
- •Baseline ALT >2.5 times the upper limit of normal
- •Oral anticoagulation with a coumarin derivative
- •History of stroke, TIA or intracranial bleeding
- •Weight <60kg
- •Pregnant females
研究组 & 干预措施
Prasugrel 60mg
Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
干预措施: Prasugrel (Drug)
Prasugrel 30mg
Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
干预措施: Prasugrel (Drug)
结局指标
主要结局
PRI Levels at 4 Hours
时间窗: 4 hours after treatment
次要结局
未报告次要终点
