Trial | NCT00251134  Report issue

Title

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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    icosapent ethyl ...

  • Study Participants

    3800
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.
Study Started
Oct 31
2003
Primary Completion
Jun 30
2008
Study Completion
Sep 30
2008
Last Update
Sep 12
2008
Estimate

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

1 Active Comparator

omega-3-acid ethyl ester 90

2 Placebo Comparator

olive oil

Criteria 

Inclusion Criteria:

Myocardial infarction 3-14 days before randomisation (STEMI and NSTEMI)
Ability to take Ω-3-FAE or olive oil without risk
Informed consent

Exclusion Criteria:

Premenopausal women who are not surgically sterile, who are pregnant or nursing, who are of child-bearing potential and are not practising acceptable means of birth control (pregnancy testing required before randomisation)
Known hypersensitivity to study medication
Dislike of fish oil
Haemorrhagic diathesis
Unwillingness to discontinue other medications containing fish oil
Legal incapacity
History of drug or alcohol abuse within 6 months
Any investigational therapy within one month of signing informed consent form
No Results Posted