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临床试验/NCT01201772
NCT01201772已完成4 期

Impact of Prasugrel Re-load on Platelet Aggregation in Patients on Chronic Prasugrel Therapy

University of Florida1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel

干预措施: Prasugrel (Drug)

Prasugrel 30mg

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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