NCT01422317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 1995

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1995

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1997

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

2.3 years

First QC Date

August 18, 2011

Last Update Submit

February 18, 2012

Conditions

Coronary DiseaseMyocardial Infarction

Keywords

n-3 fatty acidsrandomized double-blind studycoronary eventsserum lipidsantithrombotic effects of omega-3 fatty acidsanti-inflammatory effects of omega-3 fatty acidsprognostic biomarkers in myocardial infarction (MI)-patients

Outcome Measures

Primary Outcomes (1)

  • Fatal and non-fatal cardiac events

    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.

    2 years

Secondary Outcomes (5)

  • Serum lipids

    One year

  • Inflammation markers

    One year

  • Coagulation markers

    One year

  • Endothelial dysfunction

    One year

  • Oxidative stress

    One year

Study Arms (2)

n-3 fatty acids

EXPERIMENTAL

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

Corn Oil

ACTIVE COMPARATOR

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-TocopherolDrug: Corn Oil / Alpha-Tocopherol (4 mg)

Interventions

EPA / DHA / Alpha-TocopherolDRUG

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.

Also known as: Omacor-R
Corn Oiln-3 fatty acids
Corn Oil / Alpha-Tocopherol (4 mg)DRUG

Two gelatine capsules twice a day. Each capsule contains 1g Corn Oil and 4 mg Alpha-Tocopherol

Also known as: Corn oil
Corn Oil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Hospital in Rogalanad

Stavanger, 4011, Norway

Location

Related Publications (9)

  • 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.

    PMID: 3277056BACKGROUND

  • 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.

    PMID: 7514972BACKGROUND

  • 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.

    PMID: 9322583BACKGROUND

  • 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.

    PMID: 7484845BACKGROUND

  • 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.

    PMID: 2137901BACKGROUND

  • Harris WS. Fish oils and plasma lipid and lipoprotein metabolism in humans: a critical review. J Lipid Res. 1989 Jun;30(6):785-807.

    PMID: 2677200BACKGROUND

  • 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.

    PMID: 7702027BACKGROUND

  • 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.

    PMID: 9531248BACKGROUND

  • 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.

    PMID: 28791297DERIVED

MeSH Terms

Conditions

Coronary DiseaseMyocardial Infarction

Interventions

alpha-TocopherolCorn Oil

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

TocopherolsVitamin EBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Dennis WT Nilsen, PhD

    Department of Medicine, the Division of Cardiology, the Central Hospital in Rogaland, Norway, and the University of Bergen, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2011

First Posted

August 23, 2011

Study Start

September 1, 1995

Primary Completion

December 1, 1997

Study Completion

December 1, 2002

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations

NO(1)