Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation (OPERA)
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|ClinicalTrials.gov Identifier: NCT00970489|
Recruitment Status : Completed
First Posted : September 2, 2009
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Omega -3 fatty acids Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1516 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||(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|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2012|
|Experimental: Omega-3 fatty acid capsules||
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.
|Placebo Comparator: Olive Oil capsule||
Olive Oil capsules
- Any First Post-op Atrial Fibrillation or Flutter (AF) [ Time Frame: up to 10 days post-surgery or discharge, whichever sooner ]Primary: Occurrence of post-CS AF (atrial fibrillation or flutter) of at least 30 seconds duration and confirmed by rhythm strip or 12-lead ECG. This will include definite AF and probable AF (SVT likely to be AF depending on rate and other characteristics).
- Post-op Af [ Time Frame: up to 10 days post-surgery or discharge, whichever sooner ]Secondary AF endpoints included post-op AF that was sustained (>1 hour), symptomatic, or treated with pharmacological or electrical cardioversion; post-op AF excluding atrial flutter; time to first post-op AF; and the number of post-op AF episodes per patient. OPERA also evaluated the total number of in-hospital days in which any post-op AF, including sustained post-op AF, was present; and the proportion of in-hospital days free of any post-op AF. All potential episodes of post-op AF and other tachyarrhythmias were reviewed and adjudicated by a centralized Events Committee of cardiac electrophysiologists. Additional endpoints included resource utilization, major adverse cardiovascular events (MACE), arterial thromboembolism, and 30-day mortality.
- Other Arrhythmias [ Time Frame: up to 10 days post-surgery or discharge, whichever sooner ]
The first 3 suspected episodes of atrial fibrillation or flutter of at least 30 sec duration following randomization were documented, including the following information:
- Printed or digital rhythm strip and/or 12-lead ECG.
- Recording of time of onset and time of cessation.
- Additional documentation of temporally associated signs of symptoms, such as new or worsening chest pain, shortness of breath, or lightheadedness; drop in blood pressure requiring escalation of fluid or pressor treatment; or need for electrical or pharmacologic cardioversion.
- The first suspected episode of each of other supraventricular or unknown narrow-complex tachycardia of at least 30 sec duration following randomization was also documented.
- Other Endpoints [ Time Frame: up to 10 days post-surgery or discharge, whichever sooner ]
- Number of days in the ICU, of telemetry monitoring, and of total hospital stay.
- Non-AF arrhythmias of at least 30 sec duration, including non-AF-SVT, ventricular tachycardia (VT), and ventricular flutter (VF), assessed and adjudicated by the Events Committee.
- MACE: Combined total mortality, myocardial infarction, and stroke.
- Bleeding, assessed by (a) chest tube output in the 24 hour period following surgery and (b) total number of packed red blood cell (RBC) transfusions from enrollment to end of treatment (hospital discharge or post-op day 10).
- Significant adverse events: Discontinuation of study treatment, at the discretion of the treating physicians, for suspected significant allergic reaction, severe gastrointestinal intolerance, significant bleeding, or other side effects requiring discontinuation.
- Thirty-day mortality assessed
- One-year mortality assessed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970489
|United States, Massachusetts|
|US, Italy and Argentina|
|Boston, Massachusetts, United States, 02115|
|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|