Atherosclerosis Clinical Trial
Official title:
Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques: a Randomised Microarray-Study on Endarterectomy Specimens of Human Carotid Arteries
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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