Back to resultsEarly Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques
Primary Purpose
Atherosclerosis
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Atorvastatin
Gemfibrozil
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis
Eligibility Criteria
Inclusion Criteria: atherosclerosis stenosis of carotid artery Exclusion Criteria: therapy with statine or fibrate pregnancy
Sites / Locations
Outcomes
Primary Outcome Measures
expression profile in atherosclerotic plaque
Secondary Outcome Measures
Full Information
NCT ID
NCT00243672
First Posted
October 21, 2005
Last Updated
November 16, 2007
Sponsor
University Hospital Muenster
1. Study Identification
Unique Protocol Identification Number
NCT00243672
Brief Title
Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques
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 Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Withdrawn
Why Stopped
The study chair changed his employment, the realization of the study was not possible
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Muenster
4. Oversight
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Gemfibrozil
Primary Outcome Measure Information:
Title
expression profile in atherosclerotic plaque
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
atherosclerosis
stenosis of carotid artery
Exclusion Criteria:
therapy with statine or fibrate
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregor Theilmeier, MD
Organizational Affiliation
Department of Anesthesiology and Intensive Care, University Hospital Münster
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques
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