Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00294216
Status:
COMPLETED
Last Update Posted:
2006-02-20
First Post:
2006-02-17
Brief Title:
Omacor and Placebo in Carotid Plaque Stability
Sponsor:
Pronova BioPharma
Organization:
Pronova BioPharma
Study Overview
Official Title:
A Double Blind Comparison of Omacor and Placebo in Patients Awaiting Endarterectomy to Investigate the Effect on Carotid Plaque Stability
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the effect of intake of Omacor Omega-3-acid ethyl ester 90 2gday on specified parameters related to the stability of carotid plaque in patients awaiting endarterectomy
Detailed Description:
There is evidence both from epidemiological studies and large clinical trials that consumption of long-chain Omega-3 polyunsaturated fatty acids PUFA found in oily fish and fish oils protects against cardiovascular disease in Western Populations The large clinical trial GISSI-Prevention showed radical reductions in Cardiovascular Disease and Sudden Cardiac Death after the intake of Omega-3 PUFA and statistically significant effects were seen after only a few months of use
One of the models for explaining this markedly effect hypothesizes that Omega-3 PUFA with its anti inflammatory effects might act to stabilize atherosclerotic plaques by decreasing infiltration of inflammatory cells into the plaques andor by decreasing the activity of these cells once resident in the plaque A previous clinical study has showed increased incorporation of the Omega-3 fatty acids EPA and DHA in carotid plaque after intake of Omega-3 PUFA The morphological properties of the plaque was also altered showing thicker fibrous caps and less inflammation determined by the AHA and modified AHA classification
These findings are important to confirm Secondly additional indicators of plaque stability are required to strengthen the hypothesis Also the mechanisms by which the morphological changes come about need to be identified The model that is being used assesses structural changes associated with plaque rupture and instability through different important variables
Comparisons Double blind comparison of Omacor 2gday and placebo in patients awaiting endarterectomy
One of the models for explaining this markedly effect hypothesizes that Omega-3 PUFA with its anti inflammatory effects might act to stabilize atherosclerotic plaques by decreasing infiltration of inflammatory cells into the plaques andor by decreasing the activity of these cells once resident in the plaque A previous clinical study has showed increased incorporation of the Omega-3 fatty acids EPA and DHA in carotid plaque after intake of Omega-3 PUFA The morphological properties of the plaque was also altered showing thicker fibrous caps and less inflammation determined by the AHA and modified AHA classification
These findings are important to confirm Secondly additional indicators of plaque stability are required to strengthen the hypothesis Also the mechanisms by which the morphological changes come about need to be identified The model that is being used assesses structural changes associated with plaque rupture and instability through different important variables
Comparisons Double blind comparison of Omacor 2gday and placebo in patients awaiting endarterectomy
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