Biological Efficacy of Twice Daily Aspirin in Type 2 Diabetic Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Intensity of platelet agregation following exposure to 0.5 mg/ml arachidonic acid
研究概览
简要总结
The aim of the study is to evaluate platelet function variations according to the delay since last aspirin intake (12 vs 24 hours)in a population of diabetic patients with previous Coronary Artery Disease.
详细描述
We have previously demonstrated that there was a time-dependant efficacy of aspirin on platelet function. In this study, we investigate platelet function (fundamental research) according to the delay since last aspirin intake (12 vs 24 hours)in a population of diabetic patients with previous Coronary Artery Disease routinely treated with aspirin. In order to eliminate any variation linked to a cumulative dose effect of aspirn, platelet function is assessed 24 hours after a single 150 mg aspirin intake or 12 hours after a 75 mg aspirin intake given twice per day (corresponding to the same total dose of 150 mg /day). Light transmission aggregometry triggered by arachidonic acid 0.5mg/mL (LTA-AA) is the main endpoint of the study (intensity and velocity of agregation following exposure to arachidonic acid 0.5 mg/ml).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •type 2 diabetes mellitus
- •documented coronary artery disease
- •treatment with aspirin for at least 7 days before randomization
- •one of the following additional criteria defined from our previous study9: current smoking, hs-CRP > 4mg/L, fibrinogen > 4g/L and/or platelet count > 270 103/mm3
排除标准
- •oral anticoagulants, heparin, thrombolytic agents, non-steroidal anti-inflammatory drugs, prasugrel
- •family or personal history of bleeding or thrombophilic disorders
- •platelet count > 600x103/mm3 or < 150x103/mm3
- •hematocrit > 50% or < 25%
- •creatinine clearance < 30mL/min
- •low compliance before enrollment
- •cancer considered not in remission or those having undergone major surgery within the month prior to enrollment.
结局指标
主要结局
Intensity of platelet agregation following exposure to 0.5 mg/ml arachidonic acid
时间窗: 10 days
Flow cytometry study of the intensity of platelet agregation following exposure of Platelet reach plasma to 0.5 mg/ml arachidonic acid
次要结局
- Closure time after exposure of total blood to Collagen-epinephrine(10 days)
研究者
Dr Jean-Guillaume DILLINGER
Medical Doctor in the Department of Cardiology, Principal Investigator
Assistance Publique - Hôpitaux de Paris