Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00654290
First received: April 2, 2008
Last updated: April 4, 2008
Last verified: April 2008

April 2, 2008
April 4, 2008
March 2007
January 2008   (final data collection date for primary outcome measure)
incidence of atrial fibrillation post CABG [ Time Frame: 7 days post CABG ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00654290 on ClinicalTrials.gov Archive Site
bradycardia, mortality, hypotension, morbidity [ Time Frame: 7 days post CABG ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft
Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft, A Prospective Double-Blind Randomized Study

Atrial fibrillation is the most common arrhythmia post coronary bypass surgery, currently B-blockers are the class I indication to prevent AF post CABG. We decide to evaluate use of propranolol and amiodarone separately and together to find a better prophylaxis for AF peri-CABG

In this double blind randomized study 240 consecutive patients underwent elective coronary artery bypass grafting, being randomized prospectively into three groups, propranolol (p) (n=80), amiodarone (A) (n=80) and amiodarone with propranolol (AP) (n=80).

All groups received their medications from 7 days preoperatively and continued their medications for 5 days post CABG.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Atrial Fibrillation
  • Drug: Amiodarone + Propranolol
    Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG
  • Drug: Amiodarone
    Amiodarone treated 7 days pre-operation to 5 days post CABG
  • Drug: Propranolol
    Propranolol from 7 days pre-operation to 5 days post CABG
  • Experimental: P
    Propranolol from 7 days pre-operation to 5 days post CABG
    Intervention: Drug: Propranolol
  • Active Comparator: A
    Amiodarone treated 7 days pre-operation to 5 days post CABG
    Intervention: Drug: Amiodarone
  • Active Comparator: AP
    Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG
    Intervention: Drug: Amiodarone + Propranolol
Kojuri J, Mahmoodi Y, Jannati M, Shafa M, Ghazinoor M, Sharifkazemi MB. Ability of amiodarone and propranolol alone or in combination to prevent post-coronary bypass atrial fibrillation. Cardiovasc Ther. 2009 Winter;27(4):253-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
February 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient who are going to have elective CABG
  • Signing informed consent

Exclusion Criteria:

  • EF<35%
  • Bradycardia<60 per min
  • Hypotension< 100 mmhg
Both
45 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00654290
55318, NIH of IRAN
Yes
shiraz university of medical sciences/Dr kojuri, National Institute of Health
Shiraz University of Medical Sciences
Not Provided
Not Provided
Shiraz University of Medical Sciences
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP