Evaluation the Effect of the Double Maintenance Dose of Clopidogrel Versus Single Dose in Patients With Coronary Artery Disease With a BMI ≥ 27 kg.m-2
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation
研究概览
简要总结
The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel in the patient population overweight or obese with a body mass index (BMI) ≥ 27 kg.m-2.
详细描述
The goal is to evaluate the effect of the double maintenance dose of clopidogrel versus single dose in patients with proven coronary and with BMI ≥ 27 kg.m-2 1 - Biologically: study and compare the respective effects of the double dose and single dose of clopidogrel on platelet aggregation.
2 - Clinically: to study and compare the cardiovascular events and adverse effects depending on the dose of clopidogrel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female,
- •Old (e) of more than 20 years
- •BMI ≥ 27kg.m-2
- •Patients hospitalized for acute coronary syndrome (Whatever the ST segment and troponin dosage)
- •Patients with proven coronary candidates for treatment with Clopidogrel (who received a loading dose of 600mg over 2 hours or treated with 75 mg/day or 150mg / day of clopidogrel for longer than 7 days)
排除标准
- •Patients unwilling.
- •Patient participating in another study.
- •Patients with cardiogenic shock
- •Patient on anti GpIIbIIIa or stopped less than 72 hours before the test aggregability
- •Patients scheduled for surgery in less than 6 months
- •ischemic stroke older than 6 weeks.
- •History of hemorrhagic stroke (any time)
- •Patients on or candidates for AVK
- •Patients with a different anti ADP (ticlopidine, prasugrel)
- •Patients with an indication against clopidogrel (side effects, bleeding ...)
- •Thrombocytopenia < 100000/mm3
- •anemia (Ht < 30%)
- •Thrombocythaemia (Ht > 52%)
- •Pregnancy
研究组 & 干预措施
simple dose
Patients who show suboptimal response to loading dose of clopidogrel and receive 1x75 mg clopidogrel for 1 month followed by standard 75 mg clopidogrel for 3 months to one year.
干预措施: clopidogrel (Drug)
double dose
Patients who show suboptimal response to loading dose of clopidogrel and receive 1x150 mg clopidogrel for 1 month followed by standard 75 mg clopidogrel for 3 months to one year.
干预措施: clopidogrel (Drug)
结局指标
主要结局
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation
时间窗: 6 months
次要结局
- ADP-induced platelet aggregation assessed by VerifyNow test(7 days after selection of patients)