Multiphase Study to Determine if Platelet Function Analysis Results Correlate With Ischemic Events and Bleeding Complications
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
- 否
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
Clopidogrel 75 mg daily
干预措施: Clopidogrel (Drug)
Aspirin 81 mg
open-label Aspirin 81 mg daily
干预措施: Aspirin 81 mg (Drug)
Aspirin > 300mg
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
