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

Institute for Heart Attack Research Foundation (IHF)

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction

Treatments: Drug: Zodin (drug); Drug: Olive oil (placebo)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00251134

OMEGA

Details and patient eligibility

About

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.

Enrollment: 3,800 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

3,800 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

omega-3-acid ethyl ester 90

Treatment:

Drug: Zodin (drug)

2

Placebo Comparator group

Description:

olive oil

Treatment:

Drug: Olive oil (placebo)