Amiodarone to Prevent Post-Operative Arrhythmias

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251706
• Other study ID #: PAPABEAR
• Secondary ID: CIHR MCT-14764
• Status: Completed
• Phase: Phase 3
• First received: November 8, 2005
• Last updated: May 4, 2006
• Start date: February 1999
• Est. completion date: September 2004

Study information

• Verified date: November 2005
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• amiodarone

Locations

Country	Name	City	State
Canada	Libin Cardiovascular Institute / University of Calgary	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Heart and Stroke Foundation of Canada, Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Canada, 

References & 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 Replacemen — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	more than 5 minutes of post-operative atrial tachyarrhythmia
Primary	ventricular response rate of atrial tachyarrhythmias
Primary	burden of post-operate atrial tachyarrhythmias
Primary	length of hospital stay
Secondary	withdrawal of full-dose blinded therapy
Secondary	non-fatal post-operative complications
Secondary	hospital mortality