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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Zodin (drug)
* Drug: Olive oil (placebo)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>omega-3-acid ethyl ester 90 | Drug: Zodin (drug)<br>* 1 gram omega-3-acid ethyl esters 90 daily for a period of 12 months<br>|
| Placebo Comparator: 2<br>olive oil | Drug: Olive oil (placebo)<br>* 1 gram olive oil daily for a period of 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sudden cardiac death |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, omega 3-fatty acids