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Amiodarone to Prevent Post-Operative Arrhythmias

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ClinicalTrials.gov Identifier: NCT00251706
Recruitment Status : Completed
First Posted : November 10, 2005
Last Update Posted : May 5, 2006
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of Calgary

Tracking Information
First Submitted Date  ICMJE November 8, 2005
First Posted Date  ICMJE November 10, 2005
Last Update Posted Date May 5, 2006
Study Start Date  ICMJE February 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2005)
  • more than 5 minutes of post-operative atrial tachyarrhythmia
  • ventricular response rate of atrial tachyarrhythmias
  • burden of post-operate atrial tachyarrhythmias
  • length of hospital stay
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2005)
  • withdrawal of full-dose blinded therapy
  • non-fatal post-operative complications
  • hospital mortality
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amiodarone to Prevent Post-Operative Arrhythmias
Official Title  ICMJE Prophylactic Amiodarone for the Prevention of Arrhythmias That Begin Early After Revascularization, Valve Replacement, or Repair - PAPABEAR
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Drug: amiodarone
Study Arms  ICMJE Not Provided
Publications * Mitchell LB, Exner DV, Wyse DG, Connolly CJ, Prystai GD, Bayes AJ, Kidd WT, Kieser T, Burgess JJ, Ferland A, MacAdams CL, Maitland A. Prophylactic Oral Amiodarone for the Prevention of Arrhythmias that Begin Early After Revascularization, Valve Replacement, or Repair: PAPABEAR: a randomized controlled trial. JAMA. 2005 Dec 28;294(24):3093-100.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 8, 2005)
600
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00251706
Other Study ID Numbers  ICMJE PAPABEAR
CIHR MCT-14764
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE
  • Heart and Stroke Foundation of Canada
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: L. Brent Mitchell, MD University of Calgary
PRS Account University of Calgary
Verification Date November 2005

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