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

This study has been completed.
Sponsor:
Collaborators:
Trommsdorff GmbH & Co. KG Arzneimittel, Alsdorf, Germany
Pronova BioPharma
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT00251134
First received: November 8, 2005
Last updated: September 11, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Drug: Zodin (drug)
Drug: Olive oil (placebo)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • Sudden cardiac death [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Total mortality [ Time Frame: 12 months ]
  • MACCE: Total mortality, re-infarction or stroke [ Time Frame: 12 months ]
  • Non-fatal resuscitation or survived direct-current (DC)-shock > 30 days [ Time Frame: 12 months ]
  • Total rehospitalisation [ Time Frame: 12 months ]
  • Revascularisation: Percutaneous transluminal coronary angioplasty (PTCA) or Coronar artery bypass grafting (CABG) [ Time Frame: 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 ]
  • 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 ]
  • Combined endpoint of Sudden Cardiac Death or adequate ICD-shock/pacing during 12 months [ Time Frame: 12 months ]
  • Combined endpoint of total mortality or adequate ICD-shock/pacing during 12 months [ Time Frame: 12 months ]

Enrollment: 3800
Study Start Date: October 2003
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251134

Locations
Germany
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
Johanniter-Krankenhaus Rheinhausen
Duisburg, Germany, 47228
Elisabeth-Krankenhaus
Essen, Germany, 45138
Staedt. Kliniken Frankfurt/Main-Hoechst
Frankfurt am Main, Germany, 65929
Klinikum Fuerth
Fuerth, Germany, 90766
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Klinikum Ingolstadt
Ingolstadt, Germany, 85049
Klinikum Neustadt
Neustadt/Aisch, Germany, 91413
Elisabeth-Krankenhaus
Recklinghausen, Germany, 45661
Marienkrankenhaus
Soest, Germany, 59494
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Trommsdorff GmbH & Co. KG Arzneimittel, Alsdorf, Germany
Pronova BioPharma
Investigators
Principal Investigator: Jochen Senges, Prof. Dr. Stiftung Institut fuer Herzinfarktforschung, Chairman
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Jochen Senges, Stiftung Institut für Herzinfarktforschung, 67063 Ludwigshafen, Germany
ClinicalTrials.gov Identifier: NCT00251134     History of Changes
Other Study ID Numbers: OMEGA
Study First Received: November 8, 2005
Last Updated: September 11, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
myocardial infarction
omega 3-fatty acids

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Death, Sudden, Cardiac
Death
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on April 16, 2014