Coronary DiseaseNCT00198614
Carvedilol Versus Metoprolol for the Prevention of Atrial Fibrillation After Off-Pump Coronary Bypass Surgery
A study testing Carvedilol versus Metoprolol in people with Coronary Disease and Atrial Fibrillation, run by Ministry of Health, Labour and Welfare, Japan at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 89 years
- Conditions the study is for
- Coronary Disease, Atrial Fibrillation
- What is being tested?
- Carvedilol versus Metoprolol
- How many people
- 650 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2005to not given
- Phase
- Interventional
- 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 20 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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 Cardiology/American 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.
- Conditions
- Coronary Disease, Atrial Fibrillation
- Being tested
- Carvedilol versus Metoprolol
- Keywords
- Adrenergic beta-Antagonists, Carvedilol, Metoprolol, Coronary Artery Bypass, Atrial Fibrillation
- Medical subject headings
- Coronary Disease, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carvedilol versus MetoprololDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the incidence of new-onset AF during the first seven days after surgery; AF is defined as an episode of atrial fibrillation or flutter lasting for >30 seconds as detected on the continuous cardiac monitor.
Secondary outcomes (7)
the incidence, duration, and recurrence of new-onset AF after surgery and before hospital discharge
the frequency of external or internal electrical cardioversion after surgery and before hospital discharge
the incidence of AF rhythm at hospital discharge
premature discontinuation of assigned drug administration
in-hospital mortality for any cause after surgery
in-hospital morbidity after surgery
resource use after surgery until hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Labour and Welfare, Japan
- Sponsor type
- Other government
- Investigators
- Masakazu Kuro, M.D., Ph.D., Principal investigator, Department of Anesthesiology, National Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198614
- Sponsor's protocol ID
- 16C-9
- Status last verified
- Feb 2007
- First submitted
- 13 Sep 2005
- Last updated
- 1 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00198614
- Acronym / sponsor ID
- 16C-9
- Conditions
- Coronary Disease, Atrial Fibrillation
- Keywords
- Adrenergic beta-Antagonists, Carvedilol, Metoprolol, Coronary Artery Bypass, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants
- Lead sponsor
- Ministry of Health, Labour and Welfare, JapanOther government
- Study start
- Jan 2005
- First posted
- 20 Sep 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.
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 Cardiology/American 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 20 to 89 years
- Underwent isolated off-pump coronary artery bypass graft surgery
- Written informed consent
Key exclusion criteria (23 listed)
- 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
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 |
|---|---|---|
| Carvedilol versus Metoprolol | Drug | – |
Primary outcome
The primary endpoint is the incidence of new-onset AF during the first seven days after surgery; AF is defined as an episode of atrial fibrillation or flutter lasting for >30 seconds as detected on the continuous cardiac monitor.
7 secondary outcomes
the incidence, duration, and recurrence of new-onset AF after surgery and before hospital discharge
the frequency of external or internal electrical cardioversion after surgery and before hospital discharge
the incidence of AF rhythm at hospital discharge
premature discontinuation of assigned drug administration
in-hospital mortality for any cause after surgery
in-hospital morbidity after surgery
resource use after surgery until hospital discharge.
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 1 Mar 2007.
Related trials for Coronary Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Masakazu Kuro, M.D., Ph.D. principal investigator
Department of Anesthesiology, National Cardiovascular Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carvedilol versus Metoprolol in people with Coronary Disease and Atrial Fibrillation, run by Ministry of Health, Labour and Welfare, Japan at 1 site in Japan.
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 4 inclusion and 23 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 1 Mar 2007. 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 Japan. 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.
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?
The primary endpoint is the incidence of new-onset AF during the first seven days after surgery; AF is defined as an episode of atrial fibrillation or flutter lasting for >30 seconds as detected on the continuous cardiac monitor.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2007.