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Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery (FISH)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00446966
First received: March 12, 2007
Last updated: May 10, 2010
Last verified: February 2007

March 12, 2007
May 10, 2010
February 2007
December 2009   (final data collection date for primary outcome measure)
The primary endpoint is the development of postoperative atrial fibrillation or flutter after bypass surgery. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
The primary outcome in this study is post-bypass atrial fibrillation documented by ECG or rhythm strip and requiring treatment.
The primary endpoint is the development of postoperative atrial fibrillation or flutter 14 days after bypass surgery.
Complete list of historical versions of study NCT00446966 on ClinicalTrials.gov Archive Site
Time to post-operative atrial fibrillation. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
ICU and hospital lengths of stay, re-operation; bleeding, stroke, peri-operative myocardial infarction, re-hospitalization for any cardiovascular problem, Time to atrial fibrillation, Death.
ICU and hospital lengths of stay; Reoperation; Re-hospitalization for any cardiovascular problem; Time in atrial fibrillation; Atrial fibrillation occurring between postoperative days 1-5; Death.
Not Provided
Not Provided
 
Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery
Fish Oil to Inhibit Supraventricular Arrhythmias After Cardiac Surgery: The Fish Trial

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, patients undergoing elective coronary artery bypass graft surgery with or without valve repair will be treated with omega-3 polyunsaturated fatty acids perioperatively. The following hypotheses will be tested: 1. omega-3 polyunsaturated fatty acids reduces the incidence of atrial fibrillation (AF) after cardiac surgery, 2. omega-3 polyunsaturated fatty acids, administered in the perioperative period for cardiac surgery, decreases postoperative complication rates, and 3. omega-3 polyunsaturated fatty acids decrease intensive care unit and hospital length-of-stay.

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 hospital length-of-stay. Atrial fibrillation occurring after bypass surgery is associated with increased morbidity and mortality. Atrial fibrillation is also associated with an increased risk for strokes, use of potentially harmful drugs, and the need for pacemaker therapy.

This study is for patients who are undergoing elective bypass surgery. Patients who meet study criteria and who consent to participate in the study will be randomized to treatment with omega-3 fatty acids or matching corn oil placebo, prior to surgery. After surgery, treatment will continue until the primary endpoint, atrial fibrillation, is reached, or 14 days, whichever is first.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Atrial Fibrillation
Drug: Omega Three Polyunsaturated fatty acids
2 grams orally twice daily pre-operatively and 2 grams oraly daily after until primary endpoint or 14 days.
Other Name: Lovaza, Omega three polyunsaturate ethyl esters
Experimental: fish oil , corn oil
Highly purified pharmaceutical grade omega three polyunsaturated fatty acids
Intervention: Drug: Omega Three Polyunsaturated fatty acids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
January 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-85 years old.
  • Elective coronary 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 Criteria:

  • 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.
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00446966
1733860001
Yes
Chirag M Sandesara, Virginia Cardiovascular Associates
University of Iowa
GlaxoSmithKline
Study Chair: Chirag M Sandesara, MD Virginia Cardiovascular Associates
University of Iowa
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP