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Phase 3 Completed N=1,516 Randomized Quadruple-blind Prevention

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

Source: ClinicalTrials.gov NCT00970489 ↗
Enrolled (actual)
1,516
Serious AEs
18.7%
Results posted
Apr 2017
Primary outcomePrimary: Any First Post-op Atrial Fibrillation or Flutter (AF) — 233; 227 Participants
◆ Published Evidence
Highly cited
231citations · ~17 / year
Fish oil and postoperative atrial fibrillation: the Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) randomized trial.
JAMA · 2012 · Open access · Likely link

Summary

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).

Linked Publications (5)

  • Fish oil and postoperative atrial fibrillation: the Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) randomized trial.
    JAMA · 2012 · 231 citations · Open access · Likely link
  • Fish Oil and Perioperative Bleeding.
    Circulation. Cardiovascular quality and outcomes · 2018 · 69 citations · Open access · Likely link
  • Oxidative Stress Biomarkers and Incidence of Postoperative Atrial Fibrillation in the Omega-3 Fatty Acids for Prevention of Postoperative Atrial Fibrillation (OPERA) Trial.
    Journal of the American Heart Association · 2015 · 67 citations · Open access · Likely link
  • Plasma phospholipid omega-3 fatty acids and incidence of postoperative atrial fibrillation in the OPERA trial.
    Journal of the American Heart Association · 2013 · 26 citations · Open access · Likely link
  • Fish Oil Supplementation Does Not Affect Cognitive Outcomes in Cardiac Surgery Patients in the Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation (OPERA) Trial.
    The Journal of nutrition · 2018 · 8 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Any First Post-op Atrial Fibrillation or Flutter (AF)
233; 227
SECONDARY
Post-op Af
231; 224; 220; 217
SECONDARY
Other Arrhythmias
6; 11; 9; 5
SECONDARY
Other Endpoints
20; 13; 15; 8

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00970489) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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