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Amiodarone to Prevent Post-Operative Arrhythmias

Prophylactic Amiodarone for the Prevention of Arrhythmias That Begin Early After Revascularization, Valve Replacement, or Repair - PAPABEAR

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00251706
Enrollment
600
Registered
2005-11-10
Start date
1999-02-28
Completion date
2004-09-30
Last updated
2006-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, atrial flutter, amiodarone, post-operative, coronary artery bypass surgery, valve replacement or repair

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.

Interventions

DRUGamiodarone

Sponsors

Heart and Stroke Foundation of Canada
CollaboratorOTHER
Wyeth is now a wholly owned subsidiary of Pfizer
CollaboratorINDUSTRY
University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
non-fatal post-operative complications
hospital mortality
withdrawal of full-dose blinded therapy

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026