Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198614
Status:
COMPLETED
Last Update Posted:
2007-03-01
First Post:
2005-09-13
Brief Title:
Carvedilol Versus Metoprolol for the Prevention of Atrial Fibrillation After Off-Pump Coronary Bypass Surgery
Sponsor:
Ministry of Health Labour and Welfare Japan
Organization:
Ministry of Health Labour and Welfare Japan
Study Overview
Official Title:
A Comparison of the Effectiveness of Carvedilol Versus Metoprolol for Atrial Fibrillation Appearing After Off-Pump Coronary Bypass Surgery in the Carvedilol or Metoprolol Post-Revascularization Atrial Fibrillation Controlled Trial COMPACT
Status:
COMPLETED
Status Verified Date:
2007-02
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:
Postoperative new-onset atrial fibrillation AF is the most common complication stemming from coronary artery bypass graft surgery and is associated with increased early and late mortality risk Standard guidelines recommend β blockers for the prevention of AF however no prospective study has compared the relative efficacy of β-blocking agents We hypothesize that carvedilol a non-selective adrenergic blocker with both anti-inflammatory and antioxidant properties is more effective than metoprolol a conventional β1-selective antagonist in suppressing new-onset AF following off-pump coronary bypass surgery We have designed the Carvedilol or Metoprolol Post-Revascularization Atrial Fibrillation Controlled Trial COMPACT to test our hypothesis in a multi-center open-label and randomized controlled trial
Detailed Description:
Occurring in 20 to 50 of patients postoperative new-onset atrial fibrillation AF is the most common complication of coronary artery bypass graft CABG surgery Reports have indicated that the occurrence of postoperative AF is associated with a prolonged stay in the hospital readmission to the intensive care unit stroke and consequently increased overall costs Moreover recent results from both retrospective and prospective observational studies suggest that its associated early and late mortality risk is high During the past decade off-pump coronary bypass OPCAB surgery has gained widespread acceptance as an alternative to conventional on-pump CABG surgery as avoiding cardiopulmonary bypass and myocardial ischemia-reperfusion is thought to significantly reduce postoperative systemic complications Nevertheless recent studies have revealed that OPCAB surgery does not reduce the incidence of postoperative AF possibly because the consistent inflammatory differences between on-pump CABG and OPCAB surgery are present only at the beginning of the postoperative course or partially because general surgical trauma may play a greater role It has thus been anticipated that as with on-pump CABG surgery OPCAB surgery has high AF-related mortality and morbidity risks and the prevention of new-onset AF following OPCAB surgery should significantly reduce the risk of these outcomes To date most reviews reflect a growing consensus in favor of the prophylactic administration of β blockers In addition the American College of CardiologyAmerican Heart Association guidelines for CABG surgery recommend β blockers for the prevention of AF To the best of our knowledge however no prospective study has evaluated the merits of a specific β-blocking agent or concluded that each of these agents is equally efficacious
Carvedilol a non-selective beta adrenergic blocking agent approved for use in heart failure cases has a number of ancillary activities including anti-inflammatory and antioxidant properties Although the exact pathophysiology of new-onset AF following OPCAB surgery has not yet been elucidated recent reports suggest that markers of inflammation and oxidative injury are elevated in patients with non-surgical AF In addition clinical studies indicate that unlike the β1-selective agent metoprolol carvedilol has incremental benefits for AF management in heart failure patients The anti-inflammatory and antioxidant properties of carvedilol have generated interest in its use as a prophylaxis for postoperative AF
These considerations led to the organization of COMPACT a multi-center randomized controlled trial of 650 patients designed to test the hypothesis that carvedilol is more effective than metoprolol a conventional β1-selective antagonist in suppressing new-onset AF following OPCAB surgery
Carvedilol a non-selective beta adrenergic blocking agent approved for use in heart failure cases has a number of ancillary activities including anti-inflammatory and antioxidant properties Although the exact pathophysiology of new-onset AF following OPCAB surgery has not yet been elucidated recent reports suggest that markers of inflammation and oxidative injury are elevated in patients with non-surgical AF In addition clinical studies indicate that unlike the β1-selective agent metoprolol carvedilol has incremental benefits for AF management in heart failure patients The anti-inflammatory and antioxidant properties of carvedilol have generated interest in its use as a prophylaxis for postoperative AF
These considerations led to the organization of COMPACT a multi-center randomized controlled trial of 650 patients designed to test the hypothesis that carvedilol is more effective than metoprolol a conventional β1-selective antagonist in suppressing new-onset AF following OPCAB surgery
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