NCT00251134

OMEGA-Study: Effect of Omega 3-Fatty Acids on the Reduction of Sudden Cardiac Death After Myocardial Infarction

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,800 (actual)
• Sponsor: Stiftung Institut fuer Herzinfarktforschung · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Zodin (drug)	1 gram omega-3-acid ethyl esters 90 daily for a period of 12 months
DRUG	Olive oil (placebo)	1 gram olive oil daily for a period of 12 months

Timeline

• Start date: 2003-10-01
• Primary completion: 2008-06-01
• Completion: 2008-09-01
• First posted: 2005-11-09
• Last updated: 2008-09-12

Locations

10 sites across 1 country: Germany