NCT00775762Unknown3 期
Anti-Inflammatory and Anti-Platelet Effect of Clopidogrel and Aspirin vs Aspirin Alone in Symptomatic Polyvascular Disease and in Patients With Multiple Recurrent Cardiovascular Events
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- The aim of the present study is to demonstrate the superior antinflammatory effect of Clopidogrel and Aspirin vs Aspirin or Clopidogrel alone in term of levels of selected circulating inflammatory markers
研究概览
简要总结
This is a monocentric, randomized, opened study to assess the anti-inflammatory and anti-platelet effect of Clopidogrel and aspirin versus aspirin or clopidogrel alone in patients with symptomatic polyvascular disease and with multiple recurrent cardiovascular events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic polyvascular disease or recurrent cardiovascular events. In particular patients with established stable coronary artery disease associated with peripheral disease or cerebrovascular disease and patients with more than two acute cardiovascular events.
排除标准
- •chronic treatment with anticoagulant drugs and the use of other antiplatelet therapy;
- •intolerance/allergy to Aspirin or to Clopidogrel
- •platelet counts outside the range of 125-450 10^9/l
- •inflammatory or infectious disease
- •malignancies or immunologic or hematological disorders.
研究组 & 干预措施
aspirin
Active Comparator
干预措施: aspirin (Drug)
clopidogrel
Active Comparator
干预措施: clopidogrel (Drug)
clopidogrel plus aspirin
Active Comparator
干预措施: clopidogrel plus aspirin (Drug)
结局指标
主要结局
The aim of the present study is to demonstrate the superior antinflammatory effect of Clopidogrel and Aspirin vs Aspirin or Clopidogrel alone in term of levels of selected circulating inflammatory markers
时间窗: three months
次要结局
- The aim of the present study is to demonstrate the superior antiplatelet effect of Clopidogrel and Aspirin vs Aspirin or Clopidogrel alone in term of TXA2 serum levels(three months)
研究者
研究点 (1)
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Anti-inflammatory and Anti-platelet effect of Clopidogrel and Aspirin vs Aspirin alone in Symptomatic Polyvascular disease and in patients with multiple recurrent cardiovascular events. - NDPolyvascular disease and in patients with multiple recurrent cardiovascular events.MedDRA version: 9.1Level: LLTClassification code 10032377Term: Other peripheral vascular diseaseMedDRA version: 9.1Level: LLTClassification code 10028600Term: Myocardial ischaemiaEUCTR2008-004626-17-ITPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
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