Omega-3 Fatty Acids in Elderly Patients With Acute Myocardial Infarction (OMEMI)

University of Oslo (UIO)

Status: Completed

Conditions: Atrial Fibrillation; Myocardial Revascularization; Myocardial Infarction; Heart Failure

Treatments: Drug: Pikasol; Other: Corn oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01841944

2012-004478-25 (EudraCT Number)

2012/14890

Details and patient eligibility

About

The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction.

The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke, revascularizations or hospitalization for new or worsened heart failure with at least 30%.

Enrollment: 1,027 patients

Sex: All

Ages: 70 to 82 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with acute myocardial infarction discharged from hospital alive

Exclusion criteria

• Being part of another randomized trial
• Documented intolerance for omega-3 fatty acids
• Additional disease state that is thought to be incompatible with compliance to the study drugs
• Additional disease state thought to reduce survival for the follow-up time of 2 years

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,027 participants in 2 patient groups, including a placebo group

Pikasol

Active Comparator group

Description:

Pikasol®, 3 capsules (1.8 g EPA+DHA)/day

Treatment:

Drug: Pikasol

Corn oil

Placebo Comparator group

Description:

3x capsules of corn oil pr day

Treatment:

Other: Corn oil