Amiodarone to Prevent Post-Operative Arrhythmias

Sponsor

University of Calgary (Other)

Overall Status

Completed

CT.gov ID

NCT00251706

Collaborator

Heart and Stroke Foundation of Canada (Other), Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

600

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: amiodarone	Phase 3

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 1999

Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

withdrawal of full-dose blinded therapy []
non-fatal post-operative complications []
hospital mortality []

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Libin Cardiovascular Institute / University of Calgary	Calgary	Alberta	Canada	T2N 2T9

Sponsors and Collaborators

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

Investigators

Principal Investigator: L. Brent Mitchell, MD, University of Calgary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00251706

Other Study ID Numbers:

PAPABEAR
CIHR MCT-14764

First Posted:

Nov 10, 2005

Last Update Posted:

May 5, 2006

Last Verified:

Nov 1, 2005

Keywords provided by , ,

coronary artery bypass surgery

valve replacement or repair

Additional relevant MeSH terms:

Atrial Fibrillation

Amiodarone

Study Results

No Results Posted as of May 5, 2006