Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques
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|ClinicalTrials.gov Identifier: NCT00243672|
Recruitment Status : Withdrawn (The study chair changed his employment, the realization of the study was not possible)
First Posted : October 24, 2005
Last Update Posted : November 19, 2007
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).
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis||Drug: Atorvastatin Drug: Gemfibrozil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques: a Randomised Microarray-Study on Endarterectomy Specimens of Human Carotid Arteries|
|Study Start Date :||October 2005|
|Estimated Study Completion Date :||October 2007|
- expression profile in atherosclerotic plaque
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243672
|Principal Investigator:||Gregor Theilmeier, MD||Department of Anesthesiology and Intensive Care, University Hospital Münster|