Status:
COMPLETED
Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery
Lead Sponsor:
Chirag Sandesara
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to determine if omega-3 polyunsaturated fatty acids reduce atrial fibrillation and other outcomes after cardiac surgery. In this placebo-controlled trial, patien...
Detailed Description
Atrial fibrillation is the most common complication after bypass surgery. It is a significant burden to the healthcare system because it is associated with increased hospital costs and a longer hospit...
Eligibility Criteria
Inclusion
- Age 18-85 years old.
- Elective coronary artery bypass (CABG) operation with or without concomitant valve surgery planned for at least 2 days after enrollment.
- Signed, documented informed consent prior to admission to the study.
Exclusion
- Urgent or emergent bypass required to be performed \<24 hrs after screening.
- Unstable angina, requiring intervention or CABG \<24 hrs after screening.
- Decompensated congestive heart failure.
- Chronic, persistent atrial fibrillation - patient in atrial fibrillation at the time of screening or enrollment or scheduled for a maze procedure or pulmonary vein isolation at the time of surgery.
- Known sensitivity to Omacor (0mega-3 acid ethyl esters) and hypersensitivity to fish, fish products or corn oil.
- Patients requiring warfarin or Lovenox the 2 days prior to bypass surgery.
- Patients on Class I or III antiarrhythmic agents (quinidine, procainamide, disopyramide, flecainide, propafenone, moricizine, dofetilide, sotalol, amiodarone) or who have taken these drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone).
- Patients who are pregnant or nursing.
- Patients unable to provide/sign informed consent.
- Patients currently enrolled in another clinical trial without a 30 day washout period.
- Patients currently taking marine based omega-three fish oil supplements.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00446966
Start Date
February 1 2007
End Date
January 1 2010
Last Update
October 10 2018
Active Locations (1)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52246