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Completed

NCT Number: NCT01841944

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

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%.

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Key information

Conditions

Myocardial Infarction Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Heart Failure Infarction Ischemia Myocardial Ischemia Myocardial Revascularization Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

70 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asker and Bærum Hospital, Rud, Bærum, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pikasol

Drug

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

Other names: omega-3, polyunsaturated fatty acids

corn oil

Other

Corn oil (56% linoleic acid, 32% oleic acid, 10% palmitic acid), unchanged and according to the manufacturer

Primary outcomes

  1. Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure.

    Time frame: 24months

Secondary outcomes

  1. Occurence of new onset atrial fibrillation

    Time frame: 24months

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Asker & Baerum Hospital
  • Helse Stavanger HF
  • University Hospital, Akershus

Registry information

Official study title

Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality

Acronym: OMEMI

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2013
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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