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Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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Recruitment Status : Withdrawn (The study chair changed his employment, the realization of the study was not possible)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
Information provided by:
University Hospital Muenster

October 21, 2005
October 24, 2005
November 19, 2007
October 2005
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expression profile in atherosclerotic plaque
Same as current
Complete list of historical versions of study NCT00243672 on Archive Site
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Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques
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).

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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Drug: Atorvastatin
  • Drug: Gemfibrozil
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2007
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Inclusion Criteria:

  • atherosclerosis
  • stenosis of carotid artery

Exclusion Criteria:

  • therapy with statine or fibrate
  • pregnancy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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University Hospital Muenster
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Principal Investigator: Gregor Theilmeier, MD Department of Anesthesiology and Intensive Care, University Hospital Münster
University Hospital Muenster
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP