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

Primary Purpose

Myocardial Infarction, Heart Failure, Myocardial Revascularization

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Pikasol

Corn oil

About this trial

This is an interventional prevention trial for Myocardial Infarction focused on measuring Fatty Acids, Omega-3, Aged, Myocardial Infarction

Eligibility Criteria

70 Years - 82 Years (Older Adult)All SexesDoes not accept 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

Sites / Locations

Asker and Bærum Hospital
Akershus university hospital HF
Oslo University Hospital(Ullevaal)
Stavanger University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pikasol

Corn oil

Arm Description

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

3x capsules of corn oil pr day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Occurence of new onset atrial fibrillation

Full Information

NCT ID

NCT01841944

First Posted

April 16, 2013

Last Updated

August 18, 2020

Sponsor

Oslo University Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01841944

Brief Title

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

Acronym

OMEMI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

November 2012 (Actual)

Primary Completion Date

June 26, 2020 (Actual)

Study Completion Date

June 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction, Heart Failure, Myocardial Revascularization, Atrial Fibrillation

Keywords

Fatty Acids, Omega-3, Aged, Myocardial Infarction

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1027 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pikasol

Arm Type

Active Comparator

Arm Description

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

Arm Title

Corn oil

Arm Type

Placebo Comparator

Arm Description

3x capsules of corn oil pr day

Intervention Type

Drug

Intervention Name(s)

Pikasol

Other Intervention Name(s)

omega-3, polyunsaturated fatty acids

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Corn oil

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Occurence of new onset atrial fibrillation

Time Frame

24months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Maximum Age & Unit of Time

82 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harald Arnesen, MD Phd

Organizational Affiliation