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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Zodin (drug)
Olive oil (placebo)
Sponsored by
Stiftung Institut fuer Herzinfarktforschung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring myocardial infarction, omega 3-fatty acids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum der Stadt Ludwigshafen gGmbH
  • Johanniter-Krankenhaus Rheinhausen
  • Elisabeth-Krankenhaus
  • Staedt. Kliniken Frankfurt/Main-Hoechst
  • Klinikum Fuerth
  • Universitaetsklinikum Heidelberg
  • Klinikum Ingolstadt
  • Klinikum Neustadt
  • Elisabeth-Krankenhaus
  • Marienkrankenhaus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

omega-3-acid ethyl ester 90

olive oil

Outcomes

Primary Outcome Measures

Sudden cardiac death

Secondary Outcome Measures

Total mortality
MACCE: Total mortality, re-infarction or stroke
Non-fatal resuscitation or survived direct-current (DC)-shock > 30 days
Total rehospitalisation
Revascularisation: Percutaneous transluminal coronary angioplasty (PTCA) or Coronar artery bypass grafting (CABG)
Detection of ventricular tachycardia or fibrillation during 12 months by an ICD, with or without ICD-intervention (shock or antitachycardia pacing).
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
Combined endpoint of Sudden Cardiac Death or adequate ICD-shock/pacing during 12 months
Combined endpoint of total mortality or adequate ICD-shock/pacing during 12 months

Full Information

First Posted
November 8, 2005
Last Updated
September 11, 2008
Sponsor
Stiftung Institut fuer Herzinfarktforschung
Collaborators
Trommsdorff GmbH & Co. KG, Pronova BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT00251134
Brief Title
OMEGA-Study: Effect of Omega 3-Fatty Acids on the Reduction of Sudden Cardiac Death After Myocardial Infarction
Acronym
OMEGA
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stiftung Institut fuer Herzinfarktforschung
Collaborators
Trommsdorff GmbH & Co. KG, Pronova BioPharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
myocardial infarction, omega 3-fatty acids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
omega-3-acid ethyl ester 90
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
olive oil
Intervention Type
Drug
Intervention Name(s)
Zodin (drug)
Intervention Description
1 gram omega-3-acid ethyl esters 90 daily for a period of 12 months
Intervention Type
Drug
Intervention Name(s)
Olive oil (placebo)
Intervention Description
1 gram olive oil daily for a period of 12 months
Primary Outcome Measure Information:
Title
Sudden cardiac death
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Total mortality
Time Frame
12 months
Title
MACCE: Total mortality, re-infarction or stroke
Time Frame
12 months
Title
Non-fatal resuscitation or survived direct-current (DC)-shock > 30 days
Time Frame
12 months
Title
Total rehospitalisation
Time Frame
12 months
Title
Revascularisation: Percutaneous transluminal coronary angioplasty (PTCA) or Coronar artery bypass grafting (CABG)
Time Frame
12 months
Title
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
Title
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
Title
Combined endpoint of Sudden Cardiac Death or adequate ICD-shock/pacing during 12 months
Time Frame
12 months
Title
Combined endpoint of total mortality or adequate ICD-shock/pacing during 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Senges, Prof. Dr.
Organizational Affiliation
Stiftung Institut fuer Herzinfarktforschung, Chairman
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum der Stadt Ludwigshafen gGmbH
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67063
Country
Germany
Facility Name
Johanniter-Krankenhaus Rheinhausen
City
Duisburg
ZIP/Postal Code
47228
Country
Germany
Facility Name
Elisabeth-Krankenhaus
City
Essen
ZIP/Postal Code
45138
Country
Germany
Facility Name
Staedt. Kliniken Frankfurt/Main-Hoechst
City
Frankfurt am Main
ZIP/Postal Code
65929
Country
Germany
Facility Name
Klinikum Fuerth
City
Fuerth
ZIP/Postal Code
90766
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinikum Ingolstadt
City
Ingolstadt
ZIP/Postal Code
85049
Country
Germany
Facility Name
Klinikum Neustadt
City
Neustadt/Aisch
ZIP/Postal Code
91413
Country
Germany
Facility Name
Elisabeth-Krankenhaus
City
Recklinghausen
ZIP/Postal Code
45661
Country
Germany
Facility Name
Marienkrankenhaus
City
Soest
ZIP/Postal Code
59494
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17124558
Citation
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.
Results Reference
background
PubMed Identifier
24330904
Citation
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.
Results Reference
derived
PubMed Identifier
23559535
Citation
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.
Results Reference
derived
PubMed Identifier
21060071
Citation
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.
Results Reference
derived

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

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