Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231738
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2005-10-03
Brief Title:
Protective Effect of EPA on Cardiovascular Events
Sponsor:
Kobe University
Organization:
Kobe University
Study Overview
Official Title:
Effect of Eicosapentaenoic Acid EPA on Major Cardiovascular Events in Hypercholesterolemic Patients the Japan EPA Lipid Intervention Study JELIS
Status:
COMPLETED
Status Verified Date:
2005-10
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 was to test the hypothesis that the long-term use of highly 98 purified EPA in addition to HMG-CoA reductase inhibitor statin would be more effective than statin alone in preventing cardiovascular events in Japanese patients with hypercholesterolemia
Detailed Description:
Epidemiological studies from many countries including Finland Italy Japan and The Netherlands have suggested that an increased intake of dietary fish or fish oil rich in the long-chain polyunsaturated n-3 fatty acids PUFAs eicosapentaenoic acid EPA and docosahexaenoic acid DHA is inversely related to the risk of atherothrombotic diseases in particular coronary artery disease CAD
Results of many prospective observational cohort studies have found that diets rich in marine PUFAs may be protective against major cardiovascular events including mortality from CAD total cardiovascular death all-cause mortality and nonfatal myocardial infarction To date only a few studies have examined the effects of purified n-3 PUFA preparations in human subjects for short observation periods The principle aim of the current study is to test the hypothesis that the long-term use of highly purified EPAeicosapentaenoic acid 1800mgday in addition to HMG-CoA reductase inhibitor is effective in preventing cardiovascular events in Japanese patients with hypercholesterolemia
Results of many prospective observational cohort studies have found that diets rich in marine PUFAs may be protective against major cardiovascular events including mortality from CAD total cardiovascular death all-cause mortality and nonfatal myocardial infarction To date only a few studies have examined the effects of purified n-3 PUFA preparations in human subjects for short observation periods The principle aim of the current study is to test the hypothesis that the long-term use of highly purified EPAeicosapentaenoic acid 1800mgday in addition to HMG-CoA reductase inhibitor is effective in preventing cardiovascular events in Japanese patients with hypercholesterolemia
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