Completed

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

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What is being tested

Pikasol

+ Corn oil

DrugOther
Who is being recruted

Arrhythmias, Cardiac+10

+ Cardiovascular Diseases

+ Heart Diseases

From 70 to 82 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorOslo University Hospital
Last updated: August 19, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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%.

NCT01841944
Principal SponsorOslo University Hospital
Last updated: August 19, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1027 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 70 to 82 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacCardiovascular DiseasesHeart DiseasesInfarctionIschemiaNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaAtrial FibrillationHeart FailureMyocardial Infarction

Criteria

1 inclusion criteria required to participate
Patients with acute myocardial infarction discharged from hospital alive
4 exclusion criteria prevent from participating
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
Being part of another randomized trial
Documented intolerance for omega-3 fatty acids

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Placebo
3x capsules of corn oil pr day

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Asker and Bærum Hospital

Rud, NorwayOpen Asker and Bærum Hospital in Google Maps

Akershus university hospital HF

Lørenskog, Norway

Oslo University Hospital(Ullevaal)

Oslo, Norway

Stavanger University Hospital

Stavanger, Norway
Completed4 Study Centers