Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques

• Sponsor: University Hospital Muenster (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00243672
• Collaborator: (none)
• Enrollment: 100
• Duration (Months): 24

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Oct 1, 2005
• Study Completion Date: Oct 1, 2007

Outcome Measures

Primary Outcome Measures

1. expression profile in atherosclerotic plaque []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• atherosclerosis

• stenosis of carotid artery

Exclusion Criteria:

• therapy with statine or fibrate

• pregnancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital Muenster

Investigators

• Principal Investigator: Gregor Theilmeier, MD, Department of Anesthesiology and Intensive Care, University Hospital Münster

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00243672
• Other Study ID Numbers: 04-Anast-05
• First Posted: Oct 24, 2005
• Last Update Posted: Nov 19, 2007
• Last Verified: Nov 1, 2007

• Additional relevant MeSH terms: Atherosclerosis; Plaque, Atherosclerotic; Atorvastatin; Gemfibrozil

Study Results

No Results Posted as of Nov 19, 2007