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

Tracking Information
First Received Date ^ICMJE	April 2, 2008
Last Updated Date	April 4, 2008
Start Date ^ICMJE	March 2007
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 4, 2008)	incidence of atrial fibrillation post CABG [ Time Frame: 7 days post CABG ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00654290 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 4, 2008)	bradycardia, mortality, hypotension, morbidity [ Time Frame: 7 days post CABG ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft
Official Title ^ICMJE	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
Brief Summary	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
Detailed Description	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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Atrial Fibrillation
Intervention ^ICMJE	Drug: Amiodarone + Propranolol Drug: Amiodarone Drug: Propranolol
Study Arms / Comparison Groups	Experimental: Propranolol from 7 days pre-operation to 5 days post CABG Active Comparator: Amiodarone treated 7 days pre-operation to 5 days post CABG Active Comparator: Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG
Publications *	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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	240
Completion Date	February 2008
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patient who are going to have elective CABG Signing informed consent Exclusion Criteria: EF<35% Bradycardia<60 per min Hypotension< 100 mmhg
Gender	Both
Ages	45 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Iran, Islamic Republic of

Administrative Information
NCT ID ^ICMJE	NCT00654290
Responsible Party	shiraz university of medical sciences/Dr kojuri, National Institute of Health
Study ID Numbers ^ICMJE	55318, NIH of IRAN
Study Sponsor ^ICMJE	Shiraz University of Medical Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Shiraz University of Medical Sciences
Verification Date	April 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP