Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atorvastatin

Intervention Type DRUG

Gemfibrozil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* atherosclerosis
* stenosis of carotid artery

Exclusion Criteria

* therapy with statine or fibrate
* pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Gregor Theilmeier, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Intensive Care, University Hospital Münster

Countries

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Germany

Other Identifiers

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04-Anast-05

Identifier Type: -

Identifier Source: org_study_id