Omega-3 fatty acids for Prevention of post-opERative Atrial fibrillation (OPERA) - OPERA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017582-29-IT

Enrollment

1516

Registered

2010-03-22

Start date

2010-03-01

Completion date

Unknown

Last updated

2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients scheduled for cardiac surgery MedDRA version: 9.1 Level: SOC Classification code 10007541

Interventions

Trade Name: Omacor Pharmaceutical Form: Capsule, soft INN or Proposed INN: Omega-3-triglycerides Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 840- Pharmaceutical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18+ years of age. 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, ectopy and history of AF are acceptable). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Regular use (3 or more days/week) of fish oil within the past 4 weeks. Known allergy or intolerance to omega-3 or olive oil. Currently pregnant. Unable to provide informed written consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether peri-operative administration of omega-3 reduces occurrence of atrial fibrillation or flutter (AF) in patients undergoing cardiac surgery compared to placebo;Secondary Objective: To determine if omega-3 treatment reduces resource utilization as assessed by coronary care unit, telemetry, and total hospital lengths-of-stay. To determine genetic, biologic, autonomic, and electrophysiologic mediators and pathways of effects of omega-3 on cardiac arrhythmia.;Primary end point(s): To determine whether peri-operative administration of omega-3 reduces the occurrence of post- cardiac surgery AF (Fibrillation/Flutter) of at least 30 seconds duration and confirmed by rhythm strip or 12-lead ECG compared to placebo	—

Measure

Time frame

Main Objective: To determine whether peri-operative administration of omega-3 reduces occurrence of atrial fibrillation or flutter (AF) in patients undergoing cardiac surgery compared to placebo;Secondary Objective: To determine if omega-3 treatment reduces resource utilization as assessed by coronary care unit, telemetry, and total hospital lengths-of-stay. To determine genetic, biologic, autonomic, and electrophysiologic mediators and pathways of effects of omega-3 on cardiac arrhythmia.;Primary end point(s): To determine whether peri-operative administration of omega-3 reduces the occurrence of post- cardiac surgery AF (Fibrillation/Flutter) of at least 30 seconds duration and confirmed by rhythm strip or 12-lead ECG compared to placebo

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026