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临床试验/NCT01586975
NCT01586975已完成2 期

Multiphase Study to Determine if Platelet Function Analysis Results Correlate With Ischemic Events and Bleeding Complications

Northwestern University1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
93
试验地点
1
主要终点
PFA1

研究概览

简要总结

The purpose of this study is to determine if PFA results correlate with ischemic event outcomes as well as bleeding complications. Hypothesis is antiplatelet agents will be more efficacious if they are administered in a dose-adjusted manner using PFA results as a guide.

详细描述

Atherothrombotic disease is a leading killer of adults throughout the world. The current mainstay for the prevention of ischemic vascular events is the use of aspirin Antiplatelet agents are used routinely for the primary and secondary prevention of vascular events in patients with a prior history of stroke, TIA, or at high risk for the development of cerebrovascular disease. Numberous individual studies and meta-analyses have shown that essentially all of the oral antiplatelet agents have limited efficacy, with relative risk reductions in the range of 20-35%. The purpose of this study is to perform serial platelet function assays (PFAs) on patients with cerebrovascular disease who are taking antiplatelet agents and perform a pilot study to determine the feasibility of administering ASA as a dose adjusted medication using PFA. The long term goal of this study is to determine whether antiplatelet therapy will be more efficacious and/or safer if it is administered in a dose-adjusted manner.

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

入选标准

  • Patient must be taking Aspirin or Plavix
  • Patient must have had a stroke, TIA or cerebrovascular disease

排除标准

  • 未提供

研究组 & 干预措施

Clopidogrel 75 mg

Active Comparator

Clopidogrel 75 mg daily

干预措施: Clopidogrel (Drug)

Aspirin 81 mg

Active Comparator

open-label Aspirin 81 mg daily

干预措施: Aspirin 81 mg (Drug)

Aspirin > 300mg

Active Comparator

open-label Aspirin over 300 mg daily

干预措施: Aspirin >300 mg (Drug)

结局指标

主要结局

PFA1

时间窗: 3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months)

Platelet Function Analysis (PFA) lab results: PFA was performed using the PFA 100 device (Dade-Behring), which uses a higher sheer stress flow cytometry paradigm to measure the time in seconds to closing of an aperture. Normal is defined as \<172 seconds."

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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