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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Amiodarone + Propranolol
Amiodarone
Propranolol
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, coronary bypass, Amiodarone, Propranolol, Coronary Artery Bypass Graft (CABG)

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • EF<35%
  • Bradycardia<60 per min
  • Hypotension< 100 mmhg

Sites / Locations

  • Shiraz University of Medical Sciences/Cardiac Surgery and Cardiology Ward/Namazi and Shahid Faghihi Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

P

A

AP

Arm Description

Propranolol from 7 days pre-operation to 5 days post CABG

Amiodarone treated 7 days pre-operation to 5 days post CABG

Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG

Outcomes

Primary Outcome Measures

incidence of atrial fibrillation post CABG

Secondary Outcome Measures

bradycardia, mortality, hypotension, morbidity

Full Information

First Posted
April 2, 2008
Last Updated
April 4, 2008
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00654290
Brief Title
Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, coronary bypass, Amiodarone, Propranolol, Coronary Artery Bypass Graft (CABG)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P
Arm Type
Experimental
Arm Description
Propranolol from 7 days pre-operation to 5 days post CABG
Arm Title
A
Arm Type
Active Comparator
Arm Description
Amiodarone treated 7 days pre-operation to 5 days post CABG
Arm Title
AP
Arm Type
Active Comparator
Arm Description
Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG
Intervention Type
Drug
Intervention Name(s)
Amiodarone + Propranolol
Intervention Description
Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG
Intervention Type
Drug
Intervention Name(s)
Amiodarone
Intervention Description
Amiodarone treated 7 days pre-operation to 5 days post CABG
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
Propranolol from 7 days pre-operation to 5 days post CABG
Primary Outcome Measure Information:
Title
incidence of atrial fibrillation post CABG
Time Frame
7 days post CABG
Secondary Outcome Measure Information:
Title
bradycardia, mortality, hypotension, morbidity
Time Frame
7 days post CABG

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient who are going to have elective CABG Signing informed consent Exclusion Criteria: EF<35% Bradycardia<60 per min Hypotension< 100 mmhg
Facility Information:
Facility Name
Shiraz University of Medical Sciences/Cardiac Surgery and Cardiology Ward/Namazi and Shahid Faghihi Hospital
City
Shiraz
State/Province
Fars
ZIP/Postal Code
71345
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19903189
Citation
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.
Results Reference
derived

Learn more about this trial

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

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