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Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques

This study has been withdrawn prior to enrollment.
(The study chair changed his employment, the realization of the study was not possible)
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00243672
First received: October 21, 2005
Last updated: November 16, 2007
Last verified: November 2007
History of Changes

October 21, 2005
November 16, 2007
October 2005
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expression profile in atherosclerotic plaque
Same as current
Complete list of historical versions of study NCT00243672 on ClinicalTrials.gov 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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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Atherosclerosis
  • Drug: Atorvastatin
  • Drug: Gemfibrozil
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
100
October 2007
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Inclusion Criteria:

  • atherosclerosis
  • stenosis of carotid artery

Exclusion Criteria:

  • therapy with statine or fibrate
  • pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00243672
04-Anast-05
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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