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Amiodarone to Prevent Post-Operative Arrhythmias

This study has been completed.
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00251706
First received: November 8, 2005
Last updated: May 4, 2006
Last verified: November 2005
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Prophylactic Amiodarone for the Prevention of Arrhythmias That Begin Early After Revascularization, Valve Replacement, or Repair - PAPABEAR

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Calgary:

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

Estimated Enrollment: 600
Study Start Date: February 1999
Estimated Study Completion Date: September 2004
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251706

Locations
Canada, Alberta
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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00251706     History of Changes
Other Study ID Numbers: PAPABEAR, CIHR MCT-14764
Study First Received: November 8, 2005
Last Updated: May 4, 2006
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
atrial fibrillation
atrial flutter
amiodarone
 post-operative
coronary artery bypass surgery
valve replacement or repair

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 19, 2013