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

Myocardial Infarction Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251134
• Other study ID #: OMEGA
• Status: Completed
• Phase: Phase 3
• First received: November 8, 2005
• Last updated: September 11, 2008
• Start date: October 2003
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3800
• Est. completion date: September 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Myocardial infarction 3-14 days before randomisation (STEMI and NSTEMI)

• Ability to take O-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

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

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Zodin (drug)
1 gram omega-3-acid ethyl esters 90 daily for a period of 12 months
• Olive oil (placebo)
1 gram olive oil daily for a period of 12 months

Locations

Country	Name	City	State
Germany	Johanniter-Krankenhaus Rheinhausen	Duisburg
Germany	Elisabeth-Krankenhaus	Essen
Germany	Staedt. Kliniken Frankfurt/Main-Hoechst	Frankfurt am Main
Germany	Klinikum Fuerth	Fuerth
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Klinikum Ingolstadt	Ingolstadt
Germany	Klinikum der Stadt Ludwigshafen gGmbH	Ludwigshafen	Rheinland-Pfalz
Germany	Klinikum Neustadt	Neustadt/Aisch
Germany	Elisabeth-Krankenhaus	Recklinghausen
Germany	Marienkrankenhaus	Soest

Sponsors (3)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung	Pronova BioPharma, Trommsdorff GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

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