Atrial FibrillationPhase 3NCT00251706
Amiodarone to Prevent Post-Operative Arrhythmias
A Phase 3 study testing amiodarone in people with Atrial Fibrillation, run by University of Calgary at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- amiodarone
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- Feb 1999to Sep 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- non-emergent coronary artery bypass surgery or valve replacement or repair
- informed consent
Who cannot join
- 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
Show all 11Show fewer
- sinus bradycardia (less than 50 bpm) while awake
- advanced conduction system disease
- prolonged QT interval
- clinical hypo- or hyperthyroidism
- women of child bearing potential
Trial locations and contacts
1 site in 1 country.
Canada1 site
Libin Cardiovascular Institute / University of Calgary
Calgary, Alberta, T2N 2T9
About this study
Official title: Prophylactic Amiodarone for the Prevention of Arrhythmias That Begin Early After Revascularization, Valve Replacement, or Repair - PAPABEAR
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- amiodarone
- Keywords
- atrial fibrillation, atrial flutter, amiodarone, post-operative, coronary artery bypass surgery, valve replacement or repair
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amiodaroneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (3)
withdrawal of full-dose blinded therapy
non-fatal post-operative complications
hospital mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startFeb 1999
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- L. Brent Mitchell, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251706
- Sponsor's protocol ID
- PAPABEAR
- Other IDs
- CIHR MCT-14764
- Status last verified
- Nov 2005
- First submitted
- 8 Nov 2005
- Last updated
- 5 May 2006
- Results posted
- No
Publications
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 Replacement, or Repair: PAPABEAR: a randomized controlled trial. JAMA. 2005 Dec 28;294(24):3093-100. doi: 10.1001/jama.294.24.3093.
PubMed 16380589
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Amiodarone for the Prevention of Arrhythmias That Begin Early After Revascularization, Valve Replacement, or Repair - PAPABEAR
- ClinicalTrials.gov ID
- NCT00251706
- Acronym / sponsor ID
- PAPABEAR
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, atrial flutter, amiodarone, post-operative, coronary artery bypass surgery, valve replacement or repair
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Feb 1999
- Study completion
- Sep 2004
- First posted
- 10 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- non-emergent coronary artery bypass surgery or valve replacement or repair
- informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amiodarone | Drug | – |
Primary outcome
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
3 secondary outcomes
withdrawal of full-dose blinded therapy
non-fatal post-operative complications
hospital mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2006.
- Results publication: PubMed 16380589Mitchell 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 Replacement, or Repair: PAPABEAR: a randomized controlled trial. JAMA. 2005 Dec 28;294(24):3093-100. doi: 10.1001/jama.294.24.3093.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L. Brent Mitchell, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amiodarone in people with Atrial Fibrillation, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
more than 5 minutes of post-operative atrial tachyarrhythmia. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00251706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2006.