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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1027 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2020-06-26

Brief Summary

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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%.

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Detailed Description

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Conditions

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Myocardial Infarction Heart Failure Myocardial Revascularization Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pikasol

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

Group Type ACTIVE_COMPARATOR

Pikasol

Intervention Type DRUG

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

Corn oil

3x capsules of corn oil pr day

Group Type PLACEBO_COMPARATOR

Corn oil

Intervention Type OTHER

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

Interventions

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Pikasol

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

Intervention Type DRUG

Corn oil

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

Intervention Type OTHER

Other Intervention Names

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omega-3 polyunsaturated fatty acids

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Are Annesønn Kalstad

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR