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Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation

NCT00970489 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1516

Last updated 2017-04-10

Study results available
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Summary

This is a large multi-center study to examine whether peri-operative intake of n-3 polyunsaturated fatty acids (PUFA) will reduce the occurrence of post-operative atrial fibrillation or flutter (AF) in patients undergoing cardiac surgery (CS).

Conditions

Interventions

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.

DRUG

Placebo

Olive Oil capsules

Sponsors & Collaborators

  • The OPERA Investigators

    collaborator UNKNOWN

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Dariush Mozaffarian, MD DrPH · Harvard School of Public Health (HSPH)

  • 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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00970489 on ClinicalTrials.gov