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NCT00243672 Clinical Trial

Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques

Atherosclerosis Clinical Trial

Official title:
Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques: a Randomised Microarray-Study on Endarterectomy Specimens of Human Carotid Arteries

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00243672
Other study ID # 04-Anast-05
Secondary ID
Status Withdrawn
Phase Phase 4
First received October 21, 2005
Last updated November 16, 2007
Start date October 2005
Est. completion date October 2007

Study information
Verified date November 2007
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 100
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- atherosclerosis

- stenosis of carotid artery

Exclusion Criteria:

- therapy with statine or fibrate

- pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin

• Gemfibrozil

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Muenster

Outcome
Type Measure Description Time frame Safety issue
Primary expression profile in atherosclerotic plaque
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