Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251134
Status:
COMPLETED
Last Update Posted:
2008-09-12
First Post:
2005-11-08
Brief Title:
OMEGA-Study Effect of Omega 3-Fatty Acids on the Reduction of Sudden Cardiac Death After Myocardial Infarction
Sponsor:
Stiftung Institut fuer Herzinfarktforschung
Organization:
Stiftung Institut fuer Herzinfarktforschung
Study Overview
Official Title:
OMEGA A Prospective Randomised Double-Blind Placebo-Controlled Multicentre Study in Patients Who Survived Acute Myocardial Infarction to Investigate the Efficacy and Safety of 1 Gram Ω-3-Fatty Acid Ethyl Esters Ω-3FAE Daily Versus Placebo to Reduce the Risk of Sudden Cardiac Death
Status:
COMPLETED
Status Verified Date:
2008-09
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:
OMEGA
Brief Summary:
Cardiovascular disease CVD is the leading cause of death in North America and Europe The major cause of CVD is atherosclerosis like coronary artery disease CAD The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction They are divided into two groups both receiving standard post-infarction therapy The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months while the subjects in the second group receive 1 gram olive-oil as placebo Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids
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