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| Sponsors and Collaborators: |
University of Calgary Heart and Stroke Foundation of Ontario Wyeth |
|---|---|
| Information provided by: | University of Calgary |
| ClinicalTrials.gov Identifier: | NCT00251706 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: amiodarone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Prophylactic Amiodarone for the Prevention of Arrhythmias That Begin Early After Revascularization, Valve Replacement, or Repair - PAPABEAR |
| Estimated Enrollment: | 600 |
| Study Start Date: | February 1999 |
| Estimated Study Completion Date: | September 2004 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Alberta | |
| Libin Cardiovascular Institute / University of Calgary | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Principal Investigator: | L. Brent Mitchell, MD | University of Calgary |
More Information
| Study ID Numbers: | PAPABEAR, CIHR MCT-14764 |
| Study First Received: | November 8, 2005 |
| Last Updated: | May 4, 2006 |
| ClinicalTrials.gov Identifier: | NCT00251706 History of Changes |
| Health Authority: | Canada: Health Canada |
|
atrial fibrillation atrial flutter amiodarone |
post-operative coronary artery bypass surgery valve replacement or repair |
|
Vasodilator Agents Heart Diseases Cardiovascular Agents Anti-Arrhythmia Agents |
Atrial Fibrillation Amiodarone Atrial Flutter Arrhythmias, Cardiac |
|
Vasodilator Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Cardiovascular Agents Amiodarone Pharmacologic Actions |
Pathologic Processes Therapeutic Uses Cardiovascular Diseases Atrial Fibrillation Anti-Arrhythmia Agents Arrhythmias, Cardiac |
