Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251706
Status:
COMPLETED
Last Update Posted:
2006-05-05
First Post:
2005-11-08
Brief Title:
Amiodarone to Prevent Post-Operative Arrhythmias
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Prophylactic Amiodarone for the Prevention of Arrhythmias That Begin Early After Revascularization Valve Replacement or Repair - PAPABEAR
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Six hundred and one patients who were about to undergo non-emergent open-heart surgery were randomized to receive oral amiodarone 10 mgkgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIHR MCT-14764 | None | None | None |