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Recruitment Status : Withdrawn (The study chair changed his employment, the realization of the study was not possible)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

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Gemfibrozil

Primary Outcome Measures :
  1. expression profile in atherosclerotic plaque

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • atherosclerosis
  • stenosis of carotid artery

Exclusion Criteria:

  • therapy with statine or fibrate
  • pregnancy

Information from the National Library of Medicine

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 identifier (NCT number): NCT00243672

Sponsors and Collaborators
University Hospital Muenster
Principal Investigator: Gregor Theilmeier, MD Department of Anesthesiology and Intensive Care, University Hospital Münster Identifier: NCT00243672     History of Changes
Other Study ID Numbers: 04-Anast-05
First Posted: October 24, 2005    Key Record Dates
Last Update Posted: November 19, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Plaque, Atherosclerotic
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors