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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 24, 2017
Last verified: February 2017
Results First Received: July 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Atrial Fibrillation
Interventions: Drug: Omega -3 fatty acids
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 1,516 patients scheduled for cardiac surgery (CS) across 28 centers in the US, Italy, and Argentina, enrolled between Aug 2010 and Jun 2012. Inclusion criteria were broad; the main exclusions were regular use of fish oil or absence of sinus rhythm at enrollment. 48% of screened patients and 94% of eligible patients were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Ineligible patients were most often excluded because they were not in sinus rhythm (40.5%), were on fish oil (28.9%), or were unwilling to provide informed consent (23.5%).

Reporting Groups
  Description
Olive Oil Capsule

Placebo : Olive Oil capsules All patients were randomized to receive n-3 Polyunsaturated fatty acids (PUFA) or matched placebo in equal numbers using computer-generated numbers, stratified by medical center.

Treatment: Either oral n-3 PUFA (1 g capsules, each containing ~850 mg of EPA+DHA) or matching placebo (olive oil, 1 g capsules).

Total loading dose = 8 g over 2 to 4 days pre-op, followed by 2 g/d post-op until hospital discharge or until post-op day 10, whichever sooner.

Omega-3 Fatty Acid Capsules 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.

Participant Flow:   Overall Study
    Olive Oil Capsule   Omega-3 Fatty Acid Capsules
STARTED   758   758 
COMPLETED   704   717 
NOT COMPLETED   54   41 
Death/Withdrew/Criteria Violation                54                41 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients scheduled for cardiac surgery across 28 centers in the US, Italy, and Argentina, enrolled between Aug 2010 and Jun 2012. Inclusion criteria were broad; the main exclusions were regular use of fish oil or absence of sinus rhythm at enrollment. Forty-eight percent of screened patients and 94% of eligible patients were enrolled.

Reporting Groups
  Description
Olive Oil Capsule Placebo : Olive Oil capsules
Omega-3 Fatty Acid Capsules 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.
Total Total of all reporting groups

Baseline Measures
   Olive Oil Capsule   Omega-3 Fatty Acid Capsules   Total 
Overall Participants Analyzed 
[Units: Participants]
 758   758   1516 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.6  (12.4)   63.8  (12.6)   63.7  (12.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      215  28.4%      207  27.3%      422  27.8% 
Male      543  71.6%      551  72.7%      1094  72.2% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Any First Post-op Atrial Fibrillation or Flutter (AF)   [ Time Frame: up to 10 days post-surgery or discharge, whichever sooner ]

2.  Secondary:   Post-op Af   [ Time Frame: up to 10 days post-surgery or discharge, whichever sooner ]

3.  Secondary:   Other Arrhythmias   [ Time Frame: up to 10 days post-surgery or discharge, whichever sooner ]

4.  Secondary:   Other Endpoints   [ Time Frame: up to 10 days post-surgery or discharge, whichever sooner ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Best-practice guidelines for preventing post-op atrial fibrillation were recommended to Centers. The duration prior to surgery may have been too short to be effective; or the dose of n-3 PUFA too low to produce benefit


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Namasha Schelling
Organization: Harvard School of Public Health
phone: 617-432-1734
e-mail: nschelling@hsph.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Dariush Mozaffarian, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00970489     History of Changes
Other Study ID Numbers: IND-104364
Study First Received: August 31, 2009
Results First Received: July 26, 2013
Last Updated: February 24, 2017