NCT00287209

Brief Summary

The purpose of this study is to determine whether postoperatively oral treatment with high dosis amiodarone for five days after intravenously admitted bolusinfusion will minimize the risk for development of atrial fibrillation after coronary artery bypass grafting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_4 atrial-fibrillation

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, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
Last Updated

February 6, 2006

Status Verified

February 1, 2006

First QC Date

February 3, 2006

Last Update Submit

February 3, 2006

Conditions

Atrial FibrillationCoronary Artery Bypass Grafting

Keywords

RASCABG 1 - studyPostoperative atrial fibrillationRandomized, controlled trialAmiodarone

Outcome Measures

Primary Outcomes (5)

  • - Time to symptomatic atrial fibrillation, cerebral apoplexy/ transitory cerebral infarction (TCI), acute myocardial infarction (AMI), or death.

  • - Time to symptomatic or asymptomatic atrial fibrillation, cerebral apoplexy/TCI, AMI or death;

  • - Time to symptomatic or asymptomatic atrial fibrillation

  • - Time to symptomatic atrial fibrillation

  • All measured at postoperative day 7 and 30.

Secondary Outcomes (3)

  • - Length of stay at Skejby Sygehus.

  • - Length of stay at Skejby Sygehus and local hospital.

  • - Length of stay at the intensive care unit (ICU) and intermediary unit, Skejby Sygehus

Interventions

AmiodaroneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • enlistment for an elective CABG
  • age more than 18 years
  • willingness to be randomised
  • provision of informed consent

You may not qualify if:

  • enlistment for other types of heart surgery
  • earlier heart surgery
  • resting heart rate below 40 bpm.
  • AV-blockage of any degree
  • preoperative atrial fibrillation or flutter
  • former known atrial fibrillation or flutter lasting more than one month
  • hepatic dysfunction (ALAT \> twice the upper normal limit)
  • hyperthyroidism
  • pregnancy
  • breastfeeding
  • known adverse reactions to amiodarone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiothoracic and Vascular Surgery & Institute of Clinical Medicine, Skejby Sygehus, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Vibeke E Hjortdal, Professor

    Department of Cardiothoracic and Vascular Surgery & Institute of Clinical Medicine, Skejby Sygehus, Aarhus University Hospital, DK-8200 Aarhus N, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2006

First Posted

February 6, 2006

Study Start

January 1, 2004

Study Completion

August 1, 2005

Last Updated

February 6, 2006

Record last verified: 2006-02

Locations

DK(1)