Resistance to Antithrombotic Therapy in Patients Undergoing Angioplasty and Stenting for Cardiovascular Disease - Vienna REACT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Occurence of major adverse cardiovascular events (MACE)
研究概览
简要总结
Clopidogrel plays a pivotal role in the antithrombotic regimen after percutaneous intervention with stent implantation. However, response to clopidogrel shows a wide interindividual variability and a high on-treatment residual ADP-inducible platelet reactivity has already been associated with an increased risk for adverse events after coronary stenting. In the present study, platelet reactivity will be determined by 6 different platelet function tests in patients on dual antiplatelet therapy after angioplasty and stenting for peripheral, coronary and carotid artery disease. One hundred patients showing high on-treatment residual ADP-inducible platelet reactivity in 2 or more tests will be randomized to receive either 75mg or 150mg of daily clopidogrel in addition to aspirin for 3 months. The aim of the present study is to investigate the effects of intensified antithrombotic therapy (150mg clopidogrel + 100mg aspirin daily) versus standard antithrombotic therapy (75mg clopidogrel + 100mg aspirin daily) in patients with decreased clopidogrel-mediated platelet inhibition after percutaneous intervention with stent implantation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •angioplasty and stenting for peripheral, coronary or carotid artery disease
排除标准
- •known aspirin or clopidogrel intolerance
- •therapy with vitamin K antagonists (warfarin, phenprocoumon, acenocoumarol)
- •treatment with ticlopidine, dipyridamol or nonsteroidal antiinflammatory drugs
- •family or personal history of bleeding disorders
- •malignant paraproteinemias
- •myeloproliferative disorders
- •heparin-induced thrombocytopenia
- •severe hepatic failure
- •known qualitative defects in thrombocyte function
- •major surgical procedure within one week before enrollment
- •platelet count < 100.000 or > 450.000/µl
- •hemoglobin < 8 g/dl
研究组 & 干预措施
2
150 mg clopidogrel + 100 mg aspirin
干预措施: aspirin (Drug)
1
75 mg clopidogrel + 100 mg aspirin
干预措施: aspirin (Drug)
1
75 mg clopidogrel + 100 mg aspirin
干预措施: clopidogrel (Drug)
2
150 mg clopidogrel + 100 mg aspirin
干预措施: clopidogrel (Drug)
结局指标
主要结局
Occurence of major adverse cardiovascular events (MACE)
时间窗: 12 months
次要结局
未报告次要终点
研究者
Christoph W. Kopp
Prof. Dr.
Medical University of Vienna