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Amiodarone to Prevent Post-Operative Arrhythmias

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251706
Recruitment Status : Completed
First Posted : November 10, 2005
Last Update Posted : May 5, 2006
Heart and Stroke Foundation of Canada
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of Calgary

Brief Summary:
Rapid heart rhythms originating from the upper heart chambers (atrial tachyarrhythmias) are very common after open-heart surgery. The hypothesis of the PAPABEAR study is that a brief (13 day) peri-operative course of oral amiodarone therapy would be effective and safe for the prevention of these post-operative atrial tachyarrhythmias.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: amiodarone Phase 3

Detailed Description:
Six hundred and one patients who were about to undergo non-emergent open-heart surgery were randomized to receive oral amiodarone (10 mg/kg/day) or its matching placebo from six days before surgery through 6 days after surgery. The major outcome tracked was the incidence of more than 5 minutes of an atrial tachyarrhythmia that prompted therapy by the sixth post-operative day. Safety was assessed by the incidence of dosage reduction of blinded therapy, non-fatal post-operative complications, and in-hospital mortality. The randomization scheme was stratified to permit separate analysis of patients less than versus more than or equal to 65 years of age, patients having coronary artery bypass surgery alone versus those having valve surgery with or without concomitant bypass surgery, and patients also receiving versus not also receiving concomitant therapy with a beta-blocker medication.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Prophylactic Amiodarone for the Prevention of Arrhythmias That Begin Early After Revascularization, Valve Replacement, or Repair - PAPABEAR
Study Start Date : February 1999
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Primary Outcome Measures :
  1. more than 5 minutes of post-operative atrial tachyarrhythmia
  2. ventricular response rate of atrial tachyarrhythmias
  3. burden of post-operate atrial tachyarrhythmias
  4. length of hospital stay

Secondary Outcome Measures :
  1. withdrawal of full-dose blinded therapy
  2. non-fatal post-operative complications
  3. hospital mortality

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • non-emergent coronary artery bypass surgery or valve replacement or repair
  • informed consent

Exclusion Criteria:

  • any heart rhythm other than sinus
  • myocardial infarction within two weeks
  • Class IV congestive Heart Failure
  • requirement for antiarrhythmic drug therapy
  • history of sustained atrial tachyarrhythmias
  • treatment with amiodarone within 3 months
  • sinus bradycardia (less than 50 bpm) while awake
  • advanced conduction system disease
  • prolonged QT interval
  • clinical hypo- or hyperthyroidism
  • women of child bearing potential

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00251706

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Canada, Alberta
Libin Cardiovascular Institute / University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Heart and Stroke Foundation of Canada
Wyeth is now a wholly owned subsidiary of Pfizer
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Principal Investigator: L. Brent Mitchell, MD University of Calgary
Publications of Results:
Layout table for additonal information Identifier: NCT00251706    
Other Study ID Numbers: PAPABEAR
CIHR MCT-14764
First Posted: November 10, 2005    Key Record Dates
Last Update Posted: May 5, 2006
Last Verified: November 2005
Keywords provided by University of Calgary:
atrial fibrillation
atrial flutter
coronary artery bypass surgery
valve replacement or repair
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors