At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 300 enrolled

Drug / intervention

EPA / DHA / Alpha-Tocopherol +1 moredrug

Likely dose

Corn Oil / Alpha-Tocopherol (4 mg)from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01422317

NCT01422317Phase 3Completed

Compare CT.gov

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

Helse Stavanger HF·interventional·Posted Aug 23, 2011·Updated Feb 22, 2012

In Brief

A Phase 3 clinical trial evaluating EPA / DHA / Alpha-Tocopherol and Corn Oil / Alpha-Tocopherol (4 mg) for Coronary Disease and Myocardial Infarction. Completed, enrolled 300 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCoronary Disease, Myocardial Infarction

CountriesNorway

CollaboratorsUniversity of Bergen, University of Oslo, Pharmacia and Upjohn, Pronova BioPharma

Timeline

Phase 3CompletedFinished

199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 1995

Primary CompletionDec 1997

Study CompletionDec 2002

First PostedAug 2011

TodayJul 2026

First PostedAug 23, 2011

Enrollment StartSep 1, 1995

Primary CompletionDec 1, 1997

Study CompletionDec 1, 2002

TodayJul 2, 2026

Enrollment to primary: 2.3 yearsPosted 14.9 years ago

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.

Corn Oil / Alpha-Tocopherol (4 mg)drug

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