Amiodarone to Prevent Post-Operative Arrhythmias
Prophylactic Amiodarone for the Prevention of Arrhythmias That Begin Early After Revascularization, Valve Replacement, or Repair - PAPABEAR
2 other identifiers
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 atrial-fibrillation
Started Feb 1999
Longer than P75 for phase_3 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 8, 2005
CompletedFirst Posted
Study publicly available on registry
November 10, 2005
CompletedMay 5, 2006
November 1, 2005
November 8, 2005
May 4, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (3)
withdrawal of full-dose blinded therapy
non-fatal post-operative complications
hospital mortality
Interventions
Eligibility Criteria
You may qualify if:
- non-emergent coronary artery bypass surgery or valve replacement or repair
- informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Heart and Stroke Foundation of Canadacollaborator
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
Study Sites (1)
Libin Cardiovascular Institute / University of Calgary
Calgary, Alberta, T2N 2T9, Canada
Related Publications (1)
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. doi: 10.1001/jama.294.24.3093.
PMID: 16380589RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
L. Brent Mitchell, MD
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 8, 2005
First Posted
November 10, 2005
Study Start
February 1, 1999
Study Completion
September 1, 2004
Last Updated
May 5, 2006
Record last verified: 2005-11