This study has been planned to compare the effectiveness of these two drugs in hospitalized patients after CABG ,to find out the optimal treatment for atrial fibrillation.All candidates for heart surgery ( on pump CABG); who fill out the consent form to participate in research, will be included. And all patients with a history of sensitivity to propafenone; 'EF <30%; cardiogenic shock; bradycardia; marked hypotension; sick sinus; electrolyte imbalance will be excluded.Patients will be devided into tow groups.In the first group propafenone and in the second group amiodarone will be administered.Drug administration will be done at the early detection of postoperative atrial fibrillation by the ICU nurse and will be confirmed by the ICU spacialist.Also the type of atrial fibrillation and its association with other symptoms such as hypotension will be approved.The investigator will not involve in the intervention and the patients are not aware of the treatment they are receiving .So the study is double blind.At the onset of AF, patients in first group will receive propafenone (600mg PO stat and 150mg Q8h ×10 days ).And patients in second group will receive amiodarone (300mg stat and 600mg iv infusion in 12-24 hours)..In case of reasonable results in administration of any of these drugs,it can be hoped that by Using proper and appropriate dose ,atrial fibrillation occurrence in patients candidate for open heart surgery ,especially coronary artery bypass surgery will be controlled quickly and more accurately.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809092795N1
Registration date:2011-04-16, 1390/01/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-16, 1390/01/27
Registrant information
Name
Mohammad Hassan Nemati
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 1085
Email address
nemati_mhs@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Shiraz University of Medical Sciences
Expected recruitment start date
2010-02-20, 1388/12/01
Expected recruitment end date
2010-07-23, 1389/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Amiodarone versus propafenone to treat atrial fibrillation after coronary artery bypass graft surgery
Public title
Amiodarone versus propafenone to treat atrial fibrillation after coronary artery bypass graft surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:All candidates for heart surgery ( on pump CABG); who fill out the consent form to participate in research.
Exclusion criteria :All patients with a history of sensitivity to propafenone; 'EF <30%; cardiogenic shock; bradycardia; marked hypotension; sick sinus; electrolyte imbalance.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Shiraz University of Medical Sciences
Street address
Zand st., Faculty of Medicine
City
Shiraz
Postal code
Approval date
2011-01-02, 1389/10/12
Ethics committee reference number
CT-89-5352
Health conditions studied
1
Description of health condition studied
Atrial fibrillation in hospitalized patients after CABG
ICD-10 code
I97.8
ICD-10 code description
Other postprocedural disorders of circulatory system, not elsewhere classified
Primary outcomes
1
Description
Treatment of atrial fibrillation after heart surgery
Timepoint
Early detection of postoperative AF will be done by the ICU nurse and will be confirmed by ICU specialist.
Method of measurement
Monitoring and ECG use.
Secondary outcomes
empty
Intervention groups
1
Description
.At the onset of AF, patients in first group will receive propafenone (600mg PO stat and 150mg Q8h ×10 days ).
Category
Treatment - Drugs
2
Description
At the onset of AF, patients in second group will receive amiodarone (300mg stat and 600mg iv infusion in 12-24 hours).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ordibehesht Hospital
Full name of responsible person
Doctor Mohammad Hassan Nemati
Street address
Ordibehesht Hospital, Chamran street ,Shiraz
City
Shiraz
2
Recruitment center
Name of recruitment center
Shiraz Central Hospital
Full name of responsible person
Doctor Mohammad Hassan Nemati
Street address
Shiraz Central Hospital , Chamran street ,Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholamreza Hatam
Street address
Zand street , Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Mohammad Hassan Nemati
Position
Assistant Professor, Department of Cardiac Surgery
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences ,Zand street
City
Shiraz
Postal code
Phone
+98 71 1235 1090
Fax
Email
nemati_mhs@sums.ac.ir ; Nemati_mhs@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hassan Nemati
Position
Assistant Professor, Department of Cardiac Surgery
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences ,Zand street
City
Shiraz
Postal code
Phone
+98 71 1235 1090
Fax
Email
nemati_mhs@sums.ac.ir; adibvira@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)