Status:

COMPLETED

Reduction of Atrial Fibrillation Study in Patients Undergoing Coronary Artery Bypass Grafting. (RASCABG 1 Study)

Lead Sponsor:

University of Aarhus

Conditions:

Atrial Fibrillation

Coronary Artery Bypass Grafting

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 developm...

Detailed Description

New-onset atrial fibrillation (AF) after coronary bypass grafting (CABG) is common, with an incidence ranging from 5%-65%. Although postoperative atrial tachyarrhythmia is often regarded as a tempora...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

January 1 2004

Trial Type :

INTERVENTIONAL

End Date :

August 1 2005

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT00287209

Start Date

January 1 2004

End Date

August 1 2005

Last Update

February 6 2006

Active Locations (1)

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

Aarhus N, Denmark, 8200