The aim of this study was the comparison between Amiodarone and Metoprolol in the treatment of atrial fibrillation after coronary artery bypass grafting. The study was a double blind randomized clinical trial. We enrolled patients who were candidate for coronary artery bypass grafting and developed new onset atrial fibrillation after surgery in Amir-al-Momenin hospital in Arak province, Iran. These patients were divided randomly to Amiodarone (A) and Metoprolol (M) groups by random numbers table. Each group consisted of 73 cases. We prescribed 300 milligram Amiodarone state and 1 milligram per kilogram Amiodarone in the first 6 hours and then 0.5 milligram per kilogram Amiodarone for the next 18 hours in Amiodarone group. We also prescribed 1-3 milligram per kilogram per hours Metoprolol for the first 24 hours after surgery in Metoprolol group. We continued drug administration for 24 hours in both groups. We recorded atrial fibrillation frequency by ECG in both groups. Inclusion criteria: patients undergoing coronary artery bypass graft; being at the age of 45-80 years; absence of coronary artery surgery history; absence of atrial fibrillation history; not being anti Arrhythmia consumer. Exclusion criteria: patients who need defibrillation treatment; need surgery other than coronary artery bypass graft; patients who need urgency coronary artery bypass grafting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010920258N26
Registration date:2017-02-23, 1395/12/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-23, 1395/12/05
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Arak University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Amiodarone versus Metoprolol in treating atrial fibrillation after coronary artery bypass grafting
Public title
Treatment atrial fibrillation after coronary artery bypass grafting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing coronary artery bypass graft; being at the age of 45-80 years; absence of coronary artery surgery history; absence of atrial fibrillation history; not being anti Arrhythmia consumer. Exclusion criteria: patients who need defibrillation treatment; need surgery other than coronary artery bypass graft; patients who need urgency coronary artery bypass grafting.
Age
From 45 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomize by table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2015-12-21, 1394/09/30
Ethics committee reference number
IR.ARAKMU.REC.1394.239
Health conditions studied
1
Description of health condition studied
atrial fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter
Primary outcomes
1
Description
Atrial fibrillation
Timepoint
After surgery
Method of measurement
ECG
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: We prescribed 300 milligram Amiodarone state and 1 milligram per kilogram Amiodarone in the first 6 hours and then 0.5 milligram per kilogram Amiodarone for the next 18 hours in Amiodarone group.
Category
Treatment - Drugs
2
Description
Intervention group 2: We prescribed 1-3 milligram per kilogram per hours Metoprolol for the first 24 hours after surgery in Metoprolol group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr Alireza Kamali
Street address
Amiralmomenin hospital, Sardasht, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences