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Completed

NCT Number: NCT00251134

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Klinikum der Stadt Ludwigshafen gGmbH, Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zodin (drug)

Drug

1 gram omega-3-acid ethyl esters 90 daily for a period of 12 months

Olive oil (placebo)

Drug

1 gram olive oil daily for a period of 12 months

Primary outcomes

  1. Sudden cardiac death

    Time frame: 12 months

Secondary outcomes

  1. Total mortality

    Time frame: 12 months

  2. MACCE: Total mortality, re-infarction or stroke

    Time frame: 12 months

  3. Non-fatal resuscitation or survived direct-current (DC)-shock > 30 days

    Time frame: 12 months

  4. Total rehospitalisation

    Time frame: 12 months

  5. Revascularisation: Percutaneous transluminal coronary angioplasty (PTCA) or Coronar artery bypass grafting (CABG)

    Time frame: 12 months

  6. 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

  7. 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

  8. Combined endpoint of Sudden Cardiac Death or adequate ICD-shock/pacing during 12 months

    Time frame: 12 months

  9. Combined endpoint of total mortality or adequate ICD-shock/pacing during 12 months

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Stiftung Institut fuer Herzinfarktforschung

Other

Collaborators

  • Pronova BioPharma
  • Trommsdorff GmbH & Co. KG

Registry information

Official study 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.

Acronym: OMEGA

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Nov 9, 2005
Registry last updated
Sep 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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