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Myocardial InfarctionPhase 3OMEGANCT00251134

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

A Phase 3 study testing Zodin (drug) in people with Myocardial Infarction, run by Stiftung Institut fuer Herzinfarktforschung at 10 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
Zodin (drug)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,800 participants
Where
10 sitesGermany
Study dates
Oct 2003to Sep 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • Johanniter-Krankenhaus Rheinhausen

    Duisburg, 47228

  • Elisabeth-Krankenhaus

    Essen, 45138

  • Staedt. Kliniken Frankfurt/Main-Hoechst

    Frankfurt am Main, 65929

  • Klinikum Fuerth

    Fürth, 90766

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Klinikum Ingolstadt

    Ingolstadt, 85049

  • Klinikum der Stadt Ludwigshafen gGmbH

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • Klinikum Neustadt

    Neustadt/Aisch, 91413

  • Elisabeth-Krankenhaus

    Recklinghausen, 45661

  • Marienkrankenhaus

    Soest, 59494

Other trials in Germany

About this study

Official title: 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.

Being tested
Zodin (drug), Olive oil (placebo)
Keywords
myocardial infarction, omega 3-fatty acids
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zodin (drug)Drug

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

  • Olive oil (placebo)Drug

    1 gram olive oil daily for a period of 12 months

Study groups in NCT00251134
Study groupRoleWhat they receive
1Active comparatoromega-3-acid ethyl ester 90
Receives: Drug: Zodin (drug)
2Placebo comparatorolive oil
Receives: Drug: Olive oil (placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sudden cardiac death

    Measured: 12 months

Secondary outcomes (9)

  1. Total mortality

    Measured: 12 months

  2. MACCE: Total mortality, re-infarction or stroke

    Measured: 12 months

  3. Non-fatal resuscitation or survived direct-current (DC)-shock > 30 days

    Measured: 12 months

  4. Total rehospitalisation

    Measured: 12 months

  5. Revascularisation: Percutaneous transluminal coronary angioplasty (PTCA) or Coronar artery bypass grafting (CABG)

    Measured: 12 months

  6. Detection of ventricular tachycardia or fibrillation during 12 months by an ICD, with or without ICD-intervention (shock or antitachycardia pacing).

    Measured: 12 months

  7. 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

    Measured: after 12 months

  8. Combined endpoint of Sudden Cardiac Death or adequate ICD-shock/pacing during 12 months

    Measured: 12 months

  9. Combined endpoint of total mortality or adequate ICD-shock/pacing during 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2005 (estimated)
  2. Study startOct 2003
  3. Primary completionJun 2008
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251134
Sponsor's protocol ID
OMEGA
Acronym
OMEGA
Status last verified
Sep 2008
First submitted
8 Nov 2005
Last updated
12 Sep 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17124558

  • 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.

    PubMed 24330904

  • 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.

    PubMed 23559535

  • 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.

    PubMed 21060071

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zodin (drug) in people with Myocardial Infarction, run by Stiftung Institut fuer Herzinfarktforschung at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sudden cardiac death (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00251134, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2008.

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