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

Not Applicable

Completed

• Conditions: Myocardial Infarction; Heart Failure; Myocardial Revascularization; Atrial Fibrillation
• Interventions: Drug: Pikasol; Other: Corn oil

• Registration Number: NCT01841944
• Lead Sponsor: Oslo University Hospital

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-04-16
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-29
• Primary Completion: 2020-06-26
• Study Completion: 2020-06-26
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-18
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1027

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pikasol	Pikasol	Pikasol®, 3 capsules (1.8 g EPA+DHA)/day
Corn oil	Corn oil	3x capsules of corn oil pr day

Primary Outcome Measures

Name	Time	Method
Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure.	24months

Secondary Outcome Measures

Name	Time	Method
Occurence of new onset atrial fibrillation	24months

Trial Locations

Locations (4)

Asker and Bærum Hospital; 🇳🇴 Rud, Bærum, Norway

Akershus university hospital HF; 🇳🇴 Lørenskog, Norway

Oslo University Hospital(Ullevaal); 🇳🇴 Oslo, Norway

Stavanger University Hospital; 🇳🇴 Stavanger, Norway