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

Phase 3

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: Zodin (drug); Drug: Olive oil (placebo)

• Registration Number: NCT00251134
• Lead Sponsor: Stiftung Institut fuer Herzinfarktforschung

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-11-08
• Study First Submitted QC: 2005-11-08
• Study First Posted: 2005-11-09
• Primary Completion: 2008-06
• Status Verified: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2008-09-11
• Last Update Posted: 2008-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Zodin (drug)	omega-3-acid ethyl ester 90
2	Olive oil (placebo)	olive oil

Primary Outcome Measures

Name	Time	Method
Sudden cardiac death	12 months

Secondary Outcome Measures

Name	Time	Method
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
Detection of ventricular tachycardia or fibrillation during 12 months by an ICD, with or without ICD-intervention (shock or antitachycardia pacing).	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	after 12 months
Combined endpoint of Sudden Cardiac Death or adequate ICD-shock/pacing during 12 months	12 months
Combined endpoint of total mortality or adequate ICD-shock/pacing during 12 months	12 months

Trial Locations

Locations (9)

Elisabeth-Krankenhaus; 🇩🇪 Recklinghausen, Germany

Klinikum Neustadt; 🇩🇪 Neustadt/Aisch, Germany

Johanniter-Krankenhaus Rheinhausen; 🇩🇪 Duisburg, Germany

Klinikum der Stadt Ludwigshafen gGmbH; 🇩🇪 Ludwigshafen, Rheinland-Pfalz, Germany

Klinikum Ingolstadt; 🇩🇪 Ingolstadt, Germany

Staedt. Kliniken Frankfurt/Main-Hoechst; 🇩🇪 Frankfurt am Main, Germany

Klinikum Fuerth; 🇩🇪 Fuerth, Germany

Universitaetsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Marienkrankenhaus; 🇩🇪 Soest, Germany