Effects of High-dose n-3 Fatty Acids on Clinical Outcome and Serum Lipids - Omacor Following Acute Myocardial Infarction

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

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 serum lipids.The second purpose of this study was to assess the impact of high-dose n-3 fatty acids on several markers of coagulation, inflammation, endothelial dysfunction and lipid peroxidation. Re-investigation was intended after a prolonged wash-out-period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helse Stavanger HF
• Collaborators: Pharmacia and Upjohn; Pronova BioPharma; University of Bergen; University of Oslo
• Treatments: alpha-Tocopherol; Tocopherols; Tocotrienols; Vitamin E

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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