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WithdrawnNCT00243672Updated Nov 19, 2007

Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques

A Phase 4 interventional study of Atorvastatin and Gemfibrozil in Atherosclerosis, sponsored by University Hospital Muenster. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-11-19.

Sponsored by University Hospital Muenster · Phase 4, Interventional, and Treatment

Why this study was withdrawn
The study chair changed his employment, the realization of the study was not possible
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

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Conditions studied

  • Atherosclerosis
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In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's planned enrollment of 100 is close to the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

University Hospital Muenster is the lead sponsor of 189 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • atherosclerosis
  • stenosis of carotid artery

Exclusion criteria

Exclusion Criteria:

  • therapy with statine or fibrate
  • pregnancy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
100 participants (estimated)

Interventions

  • DrugAtorvastatin
  • DrugGemfibrozil
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What researchers measure

Primary outcomes

  1. expression profile in atherosclerotic plaque

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00243672
Lead sponsor
University Hospital Muenster
First posted
Oct 24, 2005
Start date
Oct 2005
Completion
Oct 2007
Last update
Nov 19, 2007

Study contacts

Gregor Theilmeier, MD
principal investigator · Department of Anesthesiology and Intensive Care, University Hospital Münster
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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