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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00251134

Acronym

OMEGA

Enrollment

3800

Registered

2005-11-09

Start date

2003-10-31

Completion date

2008-09-30

Last updated

2008-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

myocardial infarction, omega 3-fatty acids

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.

Interventions

DRUGZodin (drug)

1 gram omega-3-acid ethyl esters 90 daily for a period of 12 months

DRUGOlive oil (placebo)

1 gram olive oil daily for a period of 12 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Sudden cardiac death	12 months

Secondary

Measure	Time frame
MACCE: Total mortality, re-infarction or stroke	12 months
Non-fatal resuscitation or survived direct-current (DC)-shock > 30 days	12 months
Total rehospitalisation	12 months
Revascularisation: Percutaneous transluminal coronary angioplasty (PTCA) or Coronar artery bypass grafting (CABG)	12 months
Total mortality	12 months
Effect on the severity of depressive co-morbidity in patients surviving an acute myocardial infarction for one year: Mean BDI-II-Depression score and percentage of patients with BDI-II score ≥ 14	after 12 months
Combined endpoint of Sudden Cardiac Death or adequate ICD-shock/pacing during 12 months	12 months
Combined endpoint of total mortality or adequate ICD-shock/pacing during 12 months	12 months
Detection of ventricular tachycardia or fibrillation during 12 months by an ICD, with or without ICD-intervention (shock or antitachycardia pacing).	12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026