Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft
2 other identifiers
interventional
240
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Mar 2007
Shorter than P25 for not_applicable atrial-fibrillation
1 active site
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
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 2, 2008
CompletedFirst Posted
Study publicly available on registry
April 7, 2008
CompletedApril 7, 2008
April 1, 2008
10 months
April 2, 2008
April 4, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of atrial fibrillation post CABG
7 days post CABG
Secondary Outcomes (1)
bradycardia, mortality, hypotension, morbidity
7 days post CABG
Study Arms (3)
P
EXPERIMENTALPropranolol from 7 days pre-operation to 5 days post CABG
A
ACTIVE COMPARATORAmiodarone treated 7 days pre-operation to 5 days post CABG
AP
ACTIVE COMPARATORAmiodarone and Propranolol 7 days pre-operation to 5 days post CABG
Interventions
Eligibility Criteria
You may qualify if:
- Patient who are going to have elective CABG
- Signing informed consent
You may not qualify if:
- EF\<35%
- Bradycardia\<60 per min
- Hypotension\< 100 mmhg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shiraz University of Medical Sciences/Cardiac Surgery and Cardiology Ward/Namazi and Shahid Faghihi Hospital
Shiraz, Fars, 71345, Iran
Related Publications (1)
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. doi: 10.1111/j.1755-5922.2009.00100.x.
PMID: 19903189DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 2, 2008
First Posted
April 7, 2008
Study Start
March 1, 2007
Primary Completion
January 1, 2008
Study Completion
February 1, 2008
Last Updated
April 7, 2008
Record last verified: 2008-04