NCT00152646Unknown4 期
Platelets Induced Vasodilation, in Vitro and in Vivo Study in Patients With Arteriopathy and Healthy Subjects.
University Hospital, Angers2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2005年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- In vivo vasodilation induced by low intensity current
研究概览
简要总结
The aim of the study is to show the implication of platelets in vasodilation using in vivo and in vitro analysis and to compare the effects of placebo, aspirin and Clopidogrel in this interaction platelets/vessels.
The effects of 7 days of each treatment will be compared in healthy subjects and patients with arteriopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria healthy subjects
- •Man or Woman 18 years
- •Agreement signed
- •French health insurance
- •Able to understand the study
- •Biological haemostatic test normal
- •Vascular Doppler of lower limbs normal
- •Pressure index > 1 in both lower limbs
- •Inclusion criteria healthy subjects
- •Man or Woman 18 years
- •Agreement signed
- •French health insurance
- •Able to understand the study
- •Biological haemostatic test normal
- •Lower limbs arteriopathy (clinical, pressure index, Doppler)
排除标准
- •Unable to sign agreement
- •Subjects protected by low
- •Participation to other study
- •Changes of treatment within the 15 days before inclusion
- •Chronic treatment with Clopidogrel or drugs against inflammation
- •Severe respiratory, cardiac, kidney, hepatic insufficiency
- •Haemostatic troubles
- •Diabetic neuropathy
- •Neurologic desease (Parkinson…..)
- •Hypertension
- •Symptomatic stomach ulcer
- •Anaemia Hb<11g/l
- •Pregnant women or breast feeding
结局指标
主要结局
In vivo vasodilation induced by low intensity current
In vitro study of platelets function
In vitro vasodilation induced by platelets in isolated rat's vessels
次要结局
未报告次要终点
研究者
研究点 (2)
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