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Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation (OPERA)

This study has been completed.
Sponsor:
Collaborator:
The OPERA Investigators
Information provided by (Responsible Party):
Dariush Mozaffarian, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00970489
First received: August 31, 2009
Last updated: February 4, 2013
Last verified: February 2013
History of Changes

August 31, 2009
February 4, 2013
August 2010
May 2012   (final data collection date for primary outcome measure)
Atrial Fibrillation [ Time Frame: up to 10 days post-surgery or discharge, whichever sooner ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00970489 on ClinicalTrials.gov Archive Site
Occurrence of sustained or symptomatic atrial fibrillation [ Time Frame: up to 10 days post-surgery or discharge, whichever sooner ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation
(OPERA)Randomized Clinical Trial to Examine Whether Peri-operative Intake of n-3 Polyunsaturated Fatty Acids Will Reduce the Occurrence of Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

This is a large multi-center study to examine whether peri-operative intake of n-3 polyunsaturated fatty acids (PUFA) will reduce the occurrence of post-operative atrial fibrillation or flutter (AF) in patients undergoing cardiac surgery (CS).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Atrial Fibrillation
  • Drug: Omega -3 fatty acids
    10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
  • Drug: Placebo
    Olive Oil capsules
  • Experimental: Omega-3 fatty acid capsules
    Intervention: Drug: Omega -3 fatty acids
  • Placebo Comparator: Olive Oil capsule
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1516
June 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years or over
  • Scheduled for CS on the following day or later, including coronary artery bypass, valve surgery, any other open cardiac surgery (i.e., that includes opening of the pericardium), or any combination.
  • Sinus rhythm on current ECG (sinus bradycardia, sinus tachycardia, and ectopy are acceptable).

Exclusion Criteria:

  • Regular use (3 or more days/week) of fish oil within the past 4 weeks.
  • Known allergy or intolerance to fish oil or corn oil.
  • Currently pregnant.
  • Unable to provide informed written consent.
  • Current or planned cardiac transplant or LVAD
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00970489
IND-104364
Yes
Dariush Mozaffarian, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
The OPERA Investigators
Principal Investigator: Dariush Mozaffarian, MD DrPH Harvard School of Public Health
Principal Investigator: Roberto Marchioli, MD Laboratory of Clinical Epidemiology of Cardiovascular Disease Department of Clinical Pharmacology and Epidemiology Consorzio Mario Negri Sud Via Nazionale 8/A S. Maria Imbaro (Chieti), 66030 ITALY
Brigham and Women's Hospital
February 2013

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