MedDataX Logo

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

NCT ID: NCT00251134

Last Updated: 2008-09-12

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2008-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Infarction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

myocardial infarction omega 3-fatty acids

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

omega-3-acid ethyl ester 90

Group Type ACTIVE_COMPARATOR

Zodin (drug)

Intervention Type DRUG

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

2

olive oil

Group Type PLACEBO_COMPARATOR

Olive oil (placebo)

Intervention Type DRUG

1 gram olive oil daily for a period of 12 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zodin (drug)

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

Intervention Type DRUG

Olive oil (placebo)

1 gram olive oil daily for a period of 12 months

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Trommsdorff GmbH & Co. KG

INDUSTRY

Sponsor Role collaborator

Pronova BioPharma

INDUSTRY

Sponsor Role collaborator

Stiftung Institut fuer Herzinfarktforschung

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stiftung Institut für Herzinfarktforschung, 67063 Ludwigshafen, Germany

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jochen Senges, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Stiftung Institut fuer Herzinfarktforschung, Chairman

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Klinikum der Stadt Ludwigshafen gGmbH

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Site Status

Johanniter-Krankenhaus Rheinhausen

Duisburg, , Germany

Site Status

Elisabeth-Krankenhaus

Essen, , Germany

Site Status

Staedt. Kliniken Frankfurt/Main-Hoechst

Frankfurt am Main, , Germany

Site Status

Klinikum Fuerth

Fürth, , Germany

Site Status

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Klinikum Ingolstadt

Ingolstadt, , Germany

Site Status

Klinikum Neustadt

Neustadt/Aisch, , Germany

Site Status

Elisabeth-Krankenhaus

Recklinghausen, , Germany

Site Status

Marienkrankenhaus

Soest, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Rauch B, Schiele R, Schneider S, Gohlke H, Diller F, Gottwik M, Steinbeck G, Heer T, Katus H, Zimmer R, Erdogan A, Pfafferott C, Senges J; Omega-Study Group. Highly purified omega-3 fatty acids for secondary prevention of sudden cardiac death after myocardial infarction-aims and methods of the OMEGA-study. Cardiovasc Drugs Ther. 2006 Oct;20(5):365-75. doi: 10.1007/s10557-006-0495-6.

Reference Type BACKGROUND
PMID: 17124558 (View on PubMed)

Zimmer R, Riemer T, Rauch B, Schneider S, Schiele R, Gohlke H, Diller F, Steinbeck G, Katus H, Senges J; OMEGA-Study Group. Effects of 1-year treatment with highly purified omega-3 fatty acids on depression after myocardial infarction: results from the OMEGA trial. J Clin Psychiatry. 2013 Nov;74(11):e1037-45. doi: 10.4088/JCP.13m08453.

Reference Type DERIVED
PMID: 24330904 (View on PubMed)

Rauch B, Riemer T, Schwaab B, Schneider S, Diller F, Gohlke H, Schiele R, Katus H, Gitt A, Senges J; OMEGA study group. Short-term comprehensive cardiac rehabilitation after AMI is associated with reduced 1-year mortality: results from the OMEGA study. Eur J Prev Cardiol. 2014 Sep;21(9):1060-9. doi: 10.1177/2047487313486040. Epub 2013 Apr 4.

Reference Type DERIVED
PMID: 23559535 (View on PubMed)

Rauch B, Schiele R, Schneider S, Diller F, Victor N, Gohlke H, Gottwik M, Steinbeck G, Del Castillo U, Sack R, Worth H, Katus H, Spitzer W, Sabin G, Senges J; OMEGA Study Group. OMEGA, a randomized, placebo-controlled trial to test the effect of highly purified omega-3 fatty acids on top of modern guideline-adjusted therapy after myocardial infarction. Circulation. 2010 Nov 23;122(21):2152-9. doi: 10.1161/CIRCULATIONAHA.110.948562. Epub 2010 Nov 8.

Reference Type DERIVED
PMID: 21060071 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OMEGA

Identifier Type: -

Identifier Source: org_study_id