Follow-up Management of Peripheral Arterial Intervention With Clopidogrel MIRROR-Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Platelet activation during and after the intervention
研究概览
简要总结
The Mirror Study is a randomized, double-blinded mono-centre trial the access the periinterventinal and postinterventional administration of clopidogrel in patients with peripheral vascular disease.
详细描述
Clopidogrel is approved for secondary prevention of atherosclerosis in patients with peripheral vascular disease. Currently there are no data about the amount of platelet activation during peripheral arterial intervention, the effect of clopidogrel on platelet adhesion and its clinical impact.
Patients with chronic peripheral arterial disease receive placebo or clopidogrel before the intervention and for 6 months in follow-up. Platelet activation, the effect on macro-and microcirculation will be assessed as well as clinical endpoints.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peripheral arterial disease which requires intervention
排除标准
- •Patient already on coumadin or clopidogrel
- •Acute onset of PVD symptoms
- •Patient requiring an operation
- •Contraindication to aspirin and clopidogrel
研究组 & 干预措施
ASS + Placebo
control arm
干预措施: clopidogrel (Drug)
ASS + Plavix
active drug
干预措施: clopidogrel (Drug)
结局指标
主要结局
Platelet activation during and after the intervention
时间窗: 6-12 hours
measured in a chandler loop model
次要结局
- ABI(before patients leaves the hospital and at 6 months)
- clinical improvement(up to 6 months)
- Safety(up to 6 months)
- rate of occlusions(wihtin 6 months)