Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation (OPERA)
Design: Multinational (U.S. and Italy), multicenter, double-blind, parallel design clinical trial.
Population: About 60 people will take part in this study at UT Southwestern Medical Center at Dallas. 1,516 patients undergoing CAS in 20-30 major medical centers in the U.S., Italy, and Argentina.
Randomization and Blinding: All patients will be randomized to receive n-3 PUFA or matched placebo in a 1:1 ratio using computer-generated numbers, stratified by medical center. All investigators, patients, and providers will be blinded to treatment assignment. Either oral n-3 PUFA (1 g capsules, each containing ~850 mg of EPA+DHA) or matching placebo (corn oil, 1 g capsules). All capsules will be provided (by Pronova) to have identical appearance.
Total loading dose = 8 g over 2 to 4 days pre-op, followed by 2 g/d post-op until hospital discharge or for 10 days, whichever occurs first.
1. Age 18+ years of age.
2. 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.
3. Sinus rhythm on current ECG (sinus bradycardia, sinus tachycardia, ectopy and history of AF are acceptable).