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

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841944
• Other study ID #: 2012/14890
• Secondary ID: 2012-004478-25
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: June 26, 2020

Study information

• Verified date: August 2020
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1027
• Est. completion date: June 26, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 82 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure
• Infarction
• Myocardial Infarction
• Myocardial Revascularization

Intervention

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

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

Locations

Country	Name	City	State
Norway	Akershus university hospital HF	Lørenskog
Norway	Oslo University Hospital(Ullevaal)	Oslo
Norway	Asker and Bærum Hospital	Rud	Bærum
Norway	Stavanger University Hospital	Stavanger

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	Asker & Baerum Hospital, Helse Stavanger HF, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure.		24months
Secondary	Occurence of new onset atrial fibrillation		24months