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

September 11, 2008 updated by: Stiftung Institut fuer Herzinfarktforschung

OMEGA: A Prospective, Randomised, Double-Blind, Placebo-Controlled Multicentre Study in Patients Who Survived Acute Myocardial Infarction to Investigate the Efficacy and Safety of 1 Gram Ω-3-Fatty Acid Ethyl Esters (Ω-3FAE) Daily Versus Placebo to Reduce the Risk of Sudden Cardiac Death.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Duisburg, Germany, 47228
        • Johanniter-Krankenhaus Rheinhausen
      • Essen, Germany, 45138
        • Elisabeth-Krankenhaus
      • Frankfurt am Main, Germany, 65929
        • Staedt. Kliniken Frankfurt/Main-Hoechst
      • Fuerth, Germany, 90766
        • Klinikum Fuerth
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg
      • Ingolstadt, Germany, 85049
        • Klinikum Ingolstadt
      • Neustadt/Aisch, Germany, 91413
        • Klinikum Neustadt
      • Recklinghausen, Germany, 45661
        • Elisabeth-Krankenhaus
      • Soest, Germany, 59494
        • Marienkrankenhaus
    • Rheinland-Pfalz
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67063
        • Klinikum der Stadt Ludwigshafen gGmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Myocardial infarction 3-14 days before randomisation (STEMI and NSTEMI)
  • Ability to take Ω-3-FAE or olive oil without risk
  • Informed consent

Exclusion Criteria:

  • Premenopausal women who are not surgically sterile, who are pregnant or nursing, who are of child-bearing potential and are not practising acceptable means of birth control (pregnancy testing required before randomisation)
  • Known hypersensitivity to study medication
  • Dislike of fish oil
  • Haemorrhagic diathesis
  • Unwillingness to discontinue other medications containing fish oil
  • Legal incapacity
  • History of drug or alcohol abuse within 6 months
  • Any investigational therapy within one month of signing informed consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
omega-3-acid ethyl ester 90
Drug: Zodin (drug)
1 gram omega-3-acid ethyl esters 90 daily for a period of 12 months
Placebo Comparator: 2
olive oil
Drug: Olive oil (placebo)
1 gram olive oil daily for a period of 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sudden cardiac death
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Total mortality
Time Frame: 12 months
12 months
MACCE: Total mortality, re-infarction or stroke
Time Frame: 12 months
12 months
Non-fatal resuscitation or survived direct-current (DC)-shock > 30 days
Time Frame: 12 months
12 months
Total rehospitalisation
Time Frame: 12 months
12 months
Revascularisation: Percutaneous transluminal coronary angioplasty (PTCA) or Coronar artery bypass grafting (CABG)
Time Frame: 12 months
12 months
Detection of ventricular tachycardia or fibrillation during 12 months by an ICD, with or without ICD-intervention (shock or antitachycardia pacing).
Time Frame: 12 months
12 months
Effect on the severity of depressive co-morbidity in patients surviving an acute myocardial infarction for one year: Mean BDI-II-Depression score and percentage of patients with BDI-II score ≥ 14
Time Frame: after 12 months
after 12 months
Combined endpoint of Sudden Cardiac Death or adequate ICD-shock/pacing during 12 months
Time Frame: 12 months
12 months
Combined endpoint of total mortality or adequate ICD-shock/pacing during 12 months
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stiftung Institut fuer Herzinfarktforschung

Collaborators

Pronova BioPharma
Trommsdorff GmbH & Co. KG

Investigators

  • Principal Investigator: Jochen Senges, Prof. Dr., Stiftung Institut fuer Herzinfarktforschung, Chairman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

November 8, 2005

First Submitted That Met QC Criteria

November 8, 2005

First Posted (Estimate)

November 9, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2008

Last Update Submitted That Met QC Criteria

September 11, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMEGA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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