NCT00198614

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

March 1, 2007

Status Verified

February 1, 2007

First QC Date

September 13, 2005

Last Update Submit

February 28, 2007

Conditions

Coronary DiseaseAtrial Fibrillation

Keywords

Adrenergic beta-AntagonistsCarvedilolMetoprololCoronary Artery BypassAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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

  • +2 more secondary outcomes

Interventions

Carvedilol versus MetoprololDRUG

Eligibility Criteria

Age20 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Location

MeSH Terms

Conditions

Coronary DiseaseAtrial Fibrillation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Masakazu Kuro, M.D., Ph.D.

    Department of Anesthesiology, National Cardiovascular Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

January 1, 2005

Last Updated

March 1, 2007

Record last verified: 2007-02

Locations

JP(1)