Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243672
Status:
WITHDRAWN
Last Update Posted:
2007-11-19
First Post:
2005-10-21
Brief Title:
Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques
Sponsor:
University Hospital Muenster
Organization:
University Hospital Muenster
Study Overview
Official Title:
Early Therapeutic Effects of Statins and Fibrates on Unstable Atherosclerotic Plaques a Randomised Microarray-Study on Endarterectomy Specimens of Human Carotid Arteries
Status:
WITHDRAWN
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study chair changed his employment the realization of the study was not possible
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10mgd gemfibrozil 1200mgd 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 statinfibrateplacebo
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 10mgd gemfibrozil 1200mgd 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 statinfibrateplacebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None