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

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ClinicalTrials.gov Identifier: NCT01422317
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : February 22, 2012
Sponsor:
Collaborators:
University of Bergen
University of Oslo
Pharmacia and Upjohn
Pronova BioPharma
Information provided by (Responsible Party):
Helse Stavanger HF

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 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.

Condition or disease Intervention/treatment Phase
Coronary Disease Myocardial Infarction Drug: EPA / DHA / Alpha-Tocopherol Drug: Corn Oil / Alpha-Tocopherol (4 mg) Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a High-dose Concentrate of n-3 Fatty Acids or Corn Oil Introduced Early After an Acute Myocardial Infarction on Serum Triacylglycerol and High-density Lipoprotein (HDL)- Cholesterol
Study Start Date : September 1995
Actual Primary Completion Date : December 1997
Actual Study Completion Date : December 2002


Arm Intervention/treatment
Experimental: n-3 fatty acids
Two gelatine capsules of Omacor-R (Pronova AS, Oslo) twice a day, each capsule containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as ethylesters, in the average ratio of EPA to DHA of 1:2. Alpha-Tocopherol (4 mg) was added to each capsule.
Drug: EPA / DHA / Alpha-Tocopherol
Two gelatine capsules of Omacor-R (Pronova AS, Oslo) twice a day, each containing 850-882 mg eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as ethylesters in the average ratio of EPA to DHA of 1:2. Alpha-Tocopherol (4 mg) was added to each capsule.
Other Name: Omacor-R
Active Comparator: Corn Oil
Two gelatine capsules twice a day, each containing 1 gram of corn oil. Alpha-Tocopherol (4 mg) was added to each capsule.
Drug: EPA / DHA / Alpha-Tocopherol
Two gelatine capsules of Omacor-R (Pronova AS, Oslo) twice a day, each containing 850-882 mg eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as ethylesters in the average ratio of EPA to DHA of 1:2. Alpha-Tocopherol (4 mg) was added to each capsule.
Other Name: Omacor-R
Drug: Corn Oil / Alpha-Tocopherol (4 mg)
Two gelatine capsules twice a day. Each capsule contains 1g Corn Oil and 4 mg Alpha-Tocopherol
Other Name: Corn oil



Primary Outcome Measures :
  1. Fatal and non-fatal cardiac events [ Time Frame: 2 years ]
    Cardiac events were defined as cardiac death, resuscitation, recurrent myocardial infarction (MI) and unstable angina pectoris, presented as single or combined cardiac events. Revascularizations and death from other causes were also recorded.


Secondary Outcome Measures :
  1. Serum lipids [ Time Frame: One year ]
    Blood specimen were harvested at baseline [3-5 days post myocardial infarction (MI)] and repeated at 6 weeks, at 6 and 12 months follow-up. Serum cholesterol, high-density lipoprotein (HDL) - cholesterol and triacylglycerol were evaluated during follow-up.

  2. Inflammation markers [ Time Frame: One year ]
    Blood specimen were harvested at baseline [3-5 days post myocardial infarction (MI)] and repeated at 6 weeks, at 6 and 12 months follow-up. Several markers of inflammation [high-sensitivity C-Reactive Protein (CRP), CD40-Ligand] were evaluated during follow-up.

  3. Coagulation markers [ Time Frame: One year ]
    Blood specimen were harvested at baseline [3-5 days post myocardial infarction (MI)] and repeated at 6 weeks, at 6 and 12 months follow-up. Several markers of coagulation (fibrin monomer, fibrinogen, tissue factor, activated factor XII) were evaluated during follow-up.

  4. Endothelial dysfunction [ Time Frame: One year ]
    Blood specimen were harvested at baseline [3-5 days post myocardial infarction (MI)] and repeated at 6 weeks, at 6 and 12 months follow-up. Several markers of endothelial dysfunction (adhesion molecules, homocysteine) were evaluated during follow-up.

  5. Oxidative stress [ Time Frame: One year ]
    Blood specimen were harvested at baseline [3-5 days post myocardila infraction (MI)] and repeated at 6 weeks, at 6 and 12 months follow-up. Thiobarbituric acid Reactive Substances(TBARS), a marker of the oxidative burden of n-3 fatty acids, was evaluated during follow-up.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422317


Locations
Norway
Central Hospital in Rogalanad
Stavanger, Norway, 4011
Sponsors and Collaborators
Helse Stavanger HF
University of Bergen
University of Oslo
Pharmacia and Upjohn
Pronova BioPharma
Investigators
Principal Investigator: Dennis WT Nilsen, PhD Department of Medicine, the Division of Cardiology, the Central Hospital in Rogaland, Norway, and the University of Bergen, Norway

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01422317     History of Changes
Other Study ID Numbers: OFAMI1995
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by Helse Stavanger HF:
n-3 fatty acids
randomized double-blind study
coronary events
serum lipids
antithrombotic effects of omega-3 fatty acids
anti-inflammatory effects of omega-3 fatty acids
prognostic biomarkers in myocardial infarction (MI)-patients

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances