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临床试验/NCT00243672
NCT00243672撤回4 期

Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques: a Randomised Microarray-Study on Endarterectomy Specimens of Human Carotid Arteries

University Hospital Muenster0 个研究点目标入组 100 人开始时间: 2005年10月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
入组人数
100
主要终点
expression profile in atherosclerotic plaque

研究概览

简要总结

Rupture of unstable atherosclerotic plaques is the underlying pathophysiologic mechanism of acute coronary syndromes and thus also of perioperative myocardial ischemia. Lipid lowering drugs such as statins and fibrates have been shown to improve the outcomes of patients with atherosclerosis. This is not only mediated through their therapeutic actions on lipid metabolism, but relies on a multitude of pleiotropic effects of these substances. One of the most interesting of these effects is the stabilisation of atherosclerotic plaques.

To investigate these effects in a perioperative setting, patients scheduled for thromboendarterectomy of the carotid artery will be recruited. They will be randomised to receive either atorvastatin 10mg/d, gemfibrozil 1200mg/d or placebo for two weeks preoperatively. Specimens of carotid plaques will be obtained intraoperatively. After microscopic characterisation of plaques, DNA-microarray analyses will be done to gain insights into the transcriptional regulation and expression profiles of various types of atherosclerotic plaques under different pharmacological circumstances (stable or unstable with statin/fibrate/placebo).

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
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

入选标准

  • atherosclerosis
  • stenosis of carotid artery

排除标准

  • therapy with statine or fibrate
  • pregnancy

结局指标

主要结局

expression profile in atherosclerotic plaque

次要结局

未报告次要终点

研究者

发起方
University Hospital Muenster
申办方类型
Other

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