A Phase 3 interventional study of amiodarone in Atrial Fibrillation, sponsored by University of Calgary. Completed at 1 site in Canada. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2006-05-05.
Sponsored by University of Calgary · Phase 3, Interventional, and Prevention
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 600 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
withdrawal of full-dose blinded therapy
non-fatal post-operative complications
hospital mortality
This study is completed, as verified in Nov 2005. You cannot join it, but the record below documents what was studied.
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University of Calgary