Status:
COMPLETED
OMEGA-Study: Effect of Omega 3-Fatty Acids on the Reduction of Sudden Cardiac Death After Myocardial Infarction
Lead Sponsor:
Stiftung Institut fuer Herzinfarktforschung
Collaborating Sponsors:
Trommsdorff GmbH & Co. KG
Pronova BioPharma
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Myocardial infarction 3-14 days before randomisation (STEMI and NSTEMI)
- Ability to take Ω-3-FAE or olive oil without risk
- Informed consent
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
3800 Patients enrolled
Trial Details
Trial ID
NCT00251134
Start Date
October 1 2003
End Date
September 1 2008
Last Update
September 12 2008
Active Locations (10)
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1
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67063
2
Johanniter-Krankenhaus Rheinhausen
Duisburg, Germany, 47228
3
Elisabeth-Krankenhaus
Essen, Germany, 45138
4
Staedt. Kliniken Frankfurt/Main-Hoechst
Frankfurt am Main, Germany, 65929