NCT00251134

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,800

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_3

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 12, 2008

Status Verified

September 1, 2008

Enrollment Period

4.7 years

First QC Date

November 8, 2005

Last Update Submit

September 11, 2008

Conditions

Myocardial Infarction

Keywords

myocardial infarctionomega 3-fatty acids

Outcome Measures

Primary Outcomes (1)

  • Sudden cardiac death

    12 months

Secondary Outcomes (9)

  • Total mortality

    12 months

  • MACCE: Total mortality, re-infarction or stroke

    12 months

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

    12 months

  • Total rehospitalisation

    12 months

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

    12 months

  • +4 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

omega-3-acid ethyl ester 90

Drug: Zodin (drug)

2

PLACEBO COMPARATOR

olive oil

Drug: Olive oil (placebo)

Interventions

Zodin (drug)DRUG

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

1
Olive oil (placebo)DRUG

1 gram olive oil daily for a period of 12 months

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Klinikum der Stadt Ludwigshafen gGmbH

Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

Location

Johanniter-Krankenhaus Rheinhausen

Duisburg, 47228, Germany

Location

Elisabeth-Krankenhaus

Essen, 45138, Germany

Location

Staedt. Kliniken Frankfurt/Main-Hoechst

Frankfurt am Main, 65929, Germany

Location

Klinikum Fuerth

Fürth, 90766, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Klinikum Ingolstadt

Ingolstadt, 85049, Germany

Location

Klinikum Neustadt

Neustadt/Aisch, 91413, Germany

Location

Elisabeth-Krankenhaus

Recklinghausen, 45661, Germany

Location

Marienkrankenhaus

Soest, 59494, Germany

Location

Related Publications (4)

  • 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.

    PMID: 17124558BACKGROUND

  • 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.

    PMID: 24330904DERIVED

  • 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.

    PMID: 23559535DERIVED

  • 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.

    PMID: 21060071DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

zodinPharmaceutical PreparationsOlive Oil

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jochen Senges, Prof. Dr.

    Stiftung Institut fuer Herzinfarktforschung, Chairman

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2005

First Posted

November 9, 2005

Study Start

October 1, 2003

Primary Completion

June 1, 2008

Study Completion

September 1, 2008

Last Updated

September 12, 2008

Record last verified: 2008-09

Locations

DE(10)