Status:
COMPLETED
Carvedilol Versus Metoprolol for the Prevention of Atrial Fibrillation After Off-Pump Coronary Bypass Surgery
Lead Sponsor:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Coronary Disease
Atrial Fibrillation
Eligibility:
All Genders
20-89 years
Phase:
NA
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. Sta...
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 oc...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adult male or female patients are required to meet the following criteria:
- Aged 20 to 89 years
- Underwent isolated off-pump coronary artery bypass graft surgery
- Written informed consent
- Exclusion criteria:
- Patients with the following conditions will be excluded from the study:
- Pre- and intraoperative use of mechanical circulatory support devices, except an intra-aortic balloon pump
- Concomitant operations, such as aneurysmectomy or carotid endarterectomy
- Surgical approaches other than a median full sternotomy
- Acute myocardial infarction ≦3 days before enrollment in the trial
- Contraindication against treatment with β blockers
- Presence of preoperative chronic AF or flutter
- History of paroxysmal AF
- Presence of antidysrhythmic medication other than β blockers, calcium channel blockers, or digitalis
- A resting heart rate of less than 50 beats/min in the absence of medical therapy known to slow the sinus rate
- Endocrine disorders, such as pheochromocytoma, active hyperthyroidism, and untreated hypothyroidism
- Pregnant women and females with childbearing potential unless utilizing adequate contraception
- Preoperative need for a temporary or permanent pacemaker
- Non-interpretable electrocardiogram for P wave assessment
- Undergoing treatment for asthma or other chronic obstructive pulmonary disease
- Second- or third-degree atrioventricular block
- Sick sinus syndrome
- Uncontrolled heart failure
- Unstable insulin-dependent diabetes mellitus
- Steroid therapy requirement
- History of autoimmune diseases
- Active infectious diseases, including myocarditis or pericarditis
- Any other serious disease that could potentially complicate the management and follow-up protocols
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00198614
Start Date
January 1 2005
Last Update
March 1 2007
Active Locations (1)
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1
National Cardiovascular Center
Suita, Osaka, Japan, 565-8565