At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,516 enrolled
Drug / intervention
Omega -3 fatty acids +1 moredrug
Likely dose
Omega -3 fatty acids 10gfrom 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.
(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
In Brief
A Phase 3 clinical trial evaluating Omega -3 fatty acids and Placebo for Atrial Fibrillation. Completed, enrolled 1,516 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesUnited States
CollaboratorsThe OPERA Investigators
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2009
Enrollment StartAug 2010
Primary CompletionMay 2012
Study CompletionJun 2012
TodayJul 2026
First PostedSep 2, 2009
Enrollment StartAug 1, 2010
Primary CompletionMay 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.8 years ago
Interventions
Omega -3 fatty acidsdrug
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.
Placebodrug
Olive Oil capsules