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OMEGA-Study: Effect of Omega 3-Fatty Acids on the Reduction of Sudden Cardiac Death After Myocardial Infarction

NCT00251134 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3800

Last updated 2008-09-12

No results posted yet for this study

Summary

Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction. They are divided into two groups, both receiving standard post-infarction therapy. The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months, while the subjects in the second group receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids.

Conditions

Interventions

DRUG

Zodin (drug)

1 gram omega-3-acid ethyl esters 90 daily for a period of 12 months

DRUG

Olive oil (placebo)

1 gram olive oil daily for a period of 12 months

Sponsors & Collaborators

  • Trommsdorff GmbH & Co. KG

    collaborator INDUSTRY

  • Pronova BioPharma

    collaborator INDUSTRY

  • Stiftung Institut fuer Herzinfarktforschung

    lead OTHER

Principal Investigators

  • Jochen Senges, Prof. Dr. · Stiftung Institut fuer Herzinfarktforschung, Chairman

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2008-06-30
Completion
2008-09-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00251134 on ClinicalTrials.gov