Carvedilol Versus Metoprolol for the Prevention of Atrial Fibrillation After Off-Pump Coronary Bypass Surgery

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ministry of Health, Labour and Welfare, Japan
• Treatments: Carvedilol; Metoprolol

Criteria

Inclusion criteria:

Adult male or female patients are required to meet the following criteria:

1. Aged 20 to 89 years

2. Underwent isolated off-pump coronary artery bypass graft surgery

3. Written informed consent

Exclusion criteria:

Patients with the following conditions will be excluded from the study:

1. Pre- and intraoperative use of mechanical circulatory support devices, except an intra-aortic balloon pump

2. Concomitant operations, such as aneurysmectomy or carotid endarterectomy

3. Surgical approaches other than a median full sternotomy

4. Acute myocardial infarction ≦3 days before enrollment in the trial

5. Contraindication against treatment with β blockers

6. Presence of preoperative chronic AF or flutter

7. History of paroxysmal AF

8. Presence of antidysrhythmic medication other than β blockers, calcium channel blockers, or digitalis

9. A resting heart rate of less than 50 beats/min in the absence of medical therapy known to slow the sinus rate

10. Endocrine disorders, such as pheochromocytoma, active hyperthyroidism, and untreated hypothyroidism

11. Pregnant women and females with childbearing potential unless utilizing adequate contraception

12. Preoperative need for a temporary or permanent pacemaker

13. Non-interpretable electrocardiogram for P wave assessment

14. Undergoing treatment for asthma or other chronic obstructive pulmonary disease

15. Second- or third-degree atrioventricular block

16. Sick sinus syndrome

17. Uncontrolled heart failure

18. Unstable insulin-dependent diabetes mellitus

19. Steroid therapy requirement

20. History of autoimmune diseases

21. Active infectious diseases, including myocarditis or pericarditis

22. Any other serious disease that could potentially complicate the management and follow-up protocols