Status:
COMPLETED
Effects of High-dose n-3 Fatty Acids on Clinical Outcome and Serum Lipids - Omacor Following Acute Myocardial Infarction
Lead Sponsor:
Helse Stavanger HF
Collaborating Sponsors:
University of Bergen
University of Oslo
Conditions:
Coronary Disease
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The object of this study was to evaluate the effect of a high-dose ethylester concentrate of of n-3 fatty acids administered early after an acute myocardial infarction on subsequent cardiac events and...
Detailed Description
Results of epidemiologic studies and clinical trials indicate that moderate doses of n-3 unsaturated fatty acids reduce the risk of cardiovascular disease(CVD) and may improve prognosis. N-3 fatty aci...
Eligibility Criteria
Inclusion
- Verified an acute myocardial infarction (MI) by World Health Organization criteria
- Age above 18 years
- Discontinuation of a regular supplementation of other fish-oil products
- Signed informed consent
Exclusion
- Assumed noncompliance to protocol
- Expected survival \< 2 y because of severe heart failure (New York Heart Association class IV), malignancy, or other reasons
- Ongoing gastrointestinal bleeding or verified stomach ulcer
- Thrombocytopenia or blood platelets \< 100 x 10'9/L
- Liver insufficiency
- Participation in any other study
- Residence outside the recruitment area of this study
Key Trial Info
Start Date :
September 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01422317
Start Date
September 1 1995
End Date
December 1 2002
Last Update
February 22 2012
Active Locations (1)
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1
Central Hospital in Rogalanad
Stavanger, Norway, 4011