Status:
COMPLETED
Amiodarone to Prevent Post-Operative Arrhythmias
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Heart and Stroke Foundation of Canada
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
Phase:
PHASE3
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-ope...
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 th...
Eligibility Criteria
Inclusion
- non-emergent coronary artery bypass surgery or valve replacement or repair
- informed consent
Exclusion
- 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
Key Trial Info
Start Date :
February 1 1999
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00251706
Start Date
February 1 1999
End Date
September 1 2004
Last Update
May 5 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Libin Cardiovascular Institute / University of Calgary
Calgary, Alberta, Canada, T2N 2T9