drugset / Trial / NCT01422317
Effects of High-dose n-3 Fatty Acids on Clinical Outcome and Serum Lipids - Omacor Following Acute Myocardial Infarction
Phase 3
Completed
300 enrolled
Helse Stavanger HF
Pharmacia and Upjohn · collabPronova BioPharma · collabUniversity of Bergen · collabUniversity of Oslo · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 1995-09
- Primary completion
- 1997-12
- Completion
- 2002-12
Publications
- Background Leaf A, Weber PC. Cardiovascular effects of n-3 fatty acids. N Engl J Med. 1988 Mar 3;318(9):549-57. doi: 10.1056/NEJM198803033180905. No abstract available.
- Background Schmidt EB, Dyerberg J. Omega-3 fatty acids. Current status in cardiovascular medicine. Drugs. 1994 Mar;47(3):405-24. doi: 10.2165/00003495-199447030-00003.
- Background Connor SL, Connor WE. Are fish oils beneficial in the prevention and treatment of coronary artery disease? Am J Clin Nutr. 1997 Oct;66(4 Suppl):1020S-1031S. doi: 10.1093/ajcn/66.4.1020S.
- Background Sellmayer A, Witzgall H, Lorenz RL, Weber PC. Effects of dietary fish oil on ventricular premature complexes. Am J Cardiol. 1995 Nov 1;76(12):974-7. doi: 10.1016/s0002-9149(99)80276-8.
- Background Bonaa KH, Bjerve KS, Straume B, Gram IT, Thelle D. Effect of eicosapentaenoic and docosahexaenoic acids on blood pressure in hypertension. A population-based intervention trial from the Tromso study. N Engl J Med. 1990 Mar 22;322(12):795-801. doi: 10.1056/NEJM199003223221202.
- Background Harris WS. Fish oils and plasma lipid and lipoprotein metabolism in humans: a critical review. J Lipid Res. 1989 Jun;30(6):785-807.
- Background Eritsland J, Arnesen H, Seljeflot I, Hostmark AT. Long-term metabolic effects of n-3 polyunsaturated fatty acids in patients with coronary artery disease. Am J Clin Nutr. 1995 Apr;61(4):831-6. doi: 10.1093/ajcn/61.4.831.
- Background Jeppesen J, Hein HO, Suadicani P, Gyntelberg F. Triglyceride concentration and ischemic heart disease: an eight-year follow-up in the Copenhagen Male Study. Circulation. 1998 Mar 24;97(11):1029-36. doi: 10.1161/01.cir.97.11.1029.
- Naesgaard PA, Grundt H, Nordoy AF, Staines H, Nilsen DWT. Vitamin D Uptake in Patients Treated with a High-Dosed Purified Omega-3 Compound in a Randomized Clinical Trial Following an Acute Myocardial Infarction. Front Cardiovasc Med. 2017 Jul 24;4:41. doi: 10.3389/fcvm.2017.00041. eCollection 2017.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Corn Oil | Unknown | 1 g | — |
| Subject | DOCONEXENT | Other / unclassified | — | — |
| Subject | Eicosapentaenoic acid | Small molecule | — | — |
| Background | alpha-tocopherol | Unknown | 4 mg | — |