Effect of Plavix Treatment on NO Production Measured by Laser Doppler Method Referring to Endothelial Function in Patients With Severe Coronary Heart Disease

Sanofi1 个研究点分布在 1 个国家目标入组 39 人开始时间: 2002年12月1日最近更新: 2008年4月3日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Sanofi
入组人数: 39
试验地点: 1
主要终点: Change of the laser Doppler parameters measured after three months clopidogrel /75 mg/day/ treatment compared to the pre-treatment values.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To determine whether in the laser Doppler flowmetric parameters characteristic of endothelial dysfunction at patients with clinically manifest atherosclerosis any change can be detected at plavix (clopidogrel) treatment. Laser Doppler /LD/ measurement combined with iontophoresis evaluates the effect of acetylcholine /ACh/ /endothelium dependent/ and sodium nitroprusside /NSP/ /endothelium independent/ on the microcirculation of the skin

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 30 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Proven, peripheral arterial disease, Fontain II-III stage, patient submitted to secondary prophylactic thrombocyte aggregation inhibiting treatment
•Doppler index < 0,8

排除标准

•Hypersensitivity to the active ingredient or one of the components of the drug
•Active pathological bleeding, e.g. gastric ulcer, intracranial bleeding
•Pregnancy, breast-feeding
•Severe, known hepatic insufficiency
•Severe, known renal insufficiency
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

结局指标

主要结局

Change of the laser Doppler parameters measured after three months clopidogrel /75 mg/day/ treatment compared to the pre-treatment values.

时间窗: 3 months

次要结局

Safety of clopidogrel /75 mg/day/ treatment(3 months)

研究者

发起方

Sanofi

申办方类型

Industry

研究点 (1)

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