Omega-3 Fatty Acids in Elderly Patients With Acute Myocardial Infarction (OMEMI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Oslo University Hospital
Sponsor:
Collaborators:
University Hospital, Akershus
Asker & Baerum Hospital
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01841944
First received: April 16, 2013
Last updated: April 24, 2013
Last verified: April 2013

April 16, 2013
April 24, 2013
November 2012
November 2014   (final data collection date for primary outcome measure)
Combined total mortality, first event of non-fatal myocardial infarction, stroke and revascularization. [ Time Frame: 24months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01841944 on ClinicalTrials.gov Archive Site
Occurence of new onset atrial fibrillation [ Time Frame: 24months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Omega-3 Fatty Acids in Elderly Patients With Acute Myocardial Infarction
Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality

The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction.

The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke and revascularizations with at least 30%.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Myocardial Infarction
  • Heart Failure
  • Myocardial Revascularization
  • Atrial Fibrillation
  • Drug: Pikasol
    Pikasol®, 3 capsules (1.8 g EPA+DHA)/day
    Other Names:
    • omega-3
    • polyunsaturated fatty acids
  • Other: Corn oil
    Corn oil (56% linoleic acid, 32% oleic acid, 10% palmitic acid), unchanged and according to the manufacturer
    Other Name: Corn oil
  • Active Comparator: Pikasol
    Pikasol®, 3 capsules (1.8 g EPA+DHA)/day
    Intervention: Drug: Pikasol
  • Placebo Comparator: Corn oil
    3x capsules of corn oil pr day
    Intervention: Other: Corn oil
Laake K, Myhre P, Nordby LM, Seljeflot I, Abdelnoor M, Smith P, Tveit A, Arnesen H, Solheim S. Effects of omega 3 supplementation in elderly patients with acute myocardial infarction: design of a prospective randomized placebo controlled study. BMC Geriatr. 2014 Jun 13;14:74. doi: 10.1186/1471-2318-14-74.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1400
November 2016
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with acute myocardial infarction discharged from hospital alive

Exclusion Criteria:

  • Being part of another randomized trial
  • Documented intolerance for omega-3 fatty acids
  • Additional disease state that is thought to be incompatible with compliance to the study drugs
  • Additional disease state thought to reduce survival for the follow-up time of 2 years
Both
70 Years to 82 Years
No
Contact: Svein Solheim, MD Phd 23027541 ext +47 svein.solheim@ous-hf.no
Norway
 
NCT01841944
2012/14890, 2012-004478-25
Yes
Oslo University Hospital
Oslo University Hospital
  • University Hospital, Akershus
  • Asker & Baerum Hospital
Study Chair: Harald Arnesen, MD Phd Center for Clinical Heart Research
Study Director: Svein Solheim, MD phd Center for Clinical Heart Research
Study Director: Ingebjørg Seljeflot, Phd Center for Clinical Heart Research
Principal Investigator: Kristian Laake, MD Center for Clinical Heart Research
Principal Investigator: Peder Myhre, MD Center for Clinical Heart Research
Oslo University Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP