Omega-3 Fatty Acids in Elderly Patients With Acute Myocardial Infarction (OMEMI)
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ClinicalTrials.gov Identifier: NCT01841944 |
Recruitment Status :
Completed
First Posted : April 29, 2013
Last Update Posted : August 19, 2020
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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%.
Condition or disease | Intervention/treatment | Phase |
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Myocardial Infarction Heart Failure Myocardial Revascularization Atrial Fibrillation | Drug: Pikasol Other: Corn oil | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1027 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality |
Actual Study Start Date : | November 2012 |
Actual Primary Completion Date : | June 26, 2020 |
Actual Study Completion Date : | June 26, 2020 |

Arm | Intervention/treatment |
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Active Comparator: Pikasol
Pikasol®, 3 capsules (1.8 g EPA+DHA)/day
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Drug: Pikasol
Pikasol®, 3 capsules (1.8 g EPA+DHA)/day
Other Names:
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Placebo Comparator: Corn oil
3x capsules of corn oil pr day
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Other: Corn oil
Corn oil (56% linoleic acid, 32% oleic acid, 10% palmitic acid), unchanged and according to the manufacturer |
- Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. [ Time Frame: 24months ]
- Occurence of new onset atrial fibrillation [ Time Frame: 24months ]

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Ages Eligible for Study: | 70 Years to 82 Years (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841944
Norway | |
Asker and Bærum Hospital | |
Rud, Bærum, Norway, 1309 | |
Akershus university hospital HF | |
Lørenskog, Norway, 1478 | |
Oslo University Hospital(Ullevaal) | |
Oslo, Norway, 0424 | |
Stavanger University Hospital | |
Stavanger, Norway |
Study Chair: | Harald Arnesen, MD Phd | Center for Clinical Heart Research | |
Study Director: | Svein Solheim, MD phd | Center for Clinical Heart Research | |
Study Director: | Ingebjørg Seljeflot, Phd | Center for Clinical Heart Research | |
Principal Investigator: | Kristian Laake, MD | Center for Clinical Heart Research | |
Principal Investigator: | Peder Myhre, MD | Center for Clinical Heart Research | |
Principal Investigator: | Are A Kalstad, MD | Center for Clinical Heart Research |
Responsible Party: | Are Annesønn Kalstad, Medical Doctor, Oslo University Hospital |
ClinicalTrials.gov Identifier: | NCT01841944 |
Other Study ID Numbers: |
2012/14890 2012-004478-25 ( EudraCT Number ) |
First Posted: | April 29, 2013 Key Record Dates |
Last Update Posted: | August 19, 2020 |
Last Verified: | August 2020 |
Fatty Acids, Omega-3 Aged Myocardial Infarction |
Atrial Fibrillation Myocardial Infarction Infarction Heart Diseases Cardiovascular Diseases Arrhythmias, Cardiac |
Pathologic Processes Ischemia Necrosis Myocardial Ischemia Vascular Diseases |