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

This study has been completed.
Sponsor:
Collaborators:
University of Bergen
University of Oslo
Pharmacia and Upjohn
Pronova BioPharma
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01422317
First received: August 18, 2011
Last updated: February 18, 2012
Last verified: February 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Fatal and non-fatal cardiac events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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:
  • Serum lipids [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    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.

  • Inflammation markers [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    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.

  • Coagulation markers [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    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.

  • Endothelial dysfunction [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.

  • Oxidative stress [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Enrollment: 300
Study Start Date: September 1995
Study Completion Date: December 2002
Primary Completion Date: December 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01422317     History of Changes
Other Study ID Numbers: OFAMI1995
Study First Received: August 18, 2011
Last Updated: February 18, 2012
Health Authority: Norway: Directorate of Health

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

ClinicalTrials.gov processed this record on November 20, 2014