One of the most prevalent complications of coronary artery bypass surgery (CABG) is atrial fibrillation (AF). The present study will be carried out to define the incidence of AF after CABG and the effect of perioperative use of statins on it. A total of 150 patients will be selected from patients undergoing isolated CABG surgery in two teaching hospitals of Shiraz University of Medical Sciences. Patients who have mixed cardiac operations including valve replacement and history of atrial fibrillation will be excluded. The study will be a randomized double-blind placebo-controlled trial. Patients will be randomized to receive atorvastatin 20 mg/d or placebo. The drug will be given 3 days before surgery and 5 days thereafter. In both groups, the incidence of AF after CABG will be assessed by ECG monitoring and compared using appropriate statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711131630N1
Registration date:2013-02-23, 1391/12/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-23, 1391/12/05
Registrant information
Name
Hossein Mirkhani
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1230 7591
Email address
mirkhanh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Shiraz University of Medical Sciences
Expected recruitment start date
2012-04-07, 1391/01/19
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of atorvastatin on the incidence of atrial fibrillation in patients undergoing coronary artery bypass graft surgery
Public title
Effect of atorvastatin on cardiac arrhythmias after open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergoing isolated coronary artery bypass graft surgery. Exclusion criteria: 1. History of atrial fibrillation; 2. Renal failure with plasma creatinine greater than 2 mg/dl; 3. Malignant or inflammatory diseases; 4. Routine use of atorvastatin; 5. Mixed cardiac operations including valve replacement; 6. Using antiarrhythmic drugs except beta-blockers; 7. Active hepatic-biliary diseases; 8. Increase in serum transaminases with undetermined cause; 9. Patients re-operated because of bleeding or other complications of surgery; 10. Glucocorticoids use.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Blvd. central building of Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2011-10-06, 1390/07/14
Ethics committee reference number
CT-90-2692
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 after Coronary Artery Bypass Graft surgery
Timepoint
During 5 days after operation
Method of measurement
ECG monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Patients in case group will receive atorvastatin 20 mg, once daily 3 days before surgery, and 6 hours after extubation up to the day 5 after surgery. In the case of assisted respiration by ventilator, the drug will be administered through NG tube. All patients will receive beta blockers before surgery. During surgery, patient will be cooled to the 32 C, anesthesized with similar anesthetic agents and operated by an individual surgeon. All patients will be observed for the incidence of atrial fibrillation till discharge from hospital.
Category
Prevention
2
Description
Patients in control group will receive placebo, once daily 3 days before surgery, and 6 hours after extubation up to the day 5 after surgery. In the case of assisted respiration by ventilator, the drug will be administered through NG tube. All patients will receive beta blockers before surgery. During surgery, patient will be cooled to the 32 C, anesthesized with similar anesthetic agents and operated by an individual surgeon. All patients will be observed for the incidence of atrial fibrillation till discharge from hospital.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Teaching Hospital
Full name of responsible person
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Zand Blvd.- central building of Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Hossein Mirkhani
Position
Associate professor of pharmacology
Other areas of specialty/work
Street address
School of Medicine, Zand Blvd.
City
Shiraz
Postal code
Phone
+98 71 1230 7591
Fax
Email
mirkhanh@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hossein Mirkhani
Position
Ph. D. in Pharmacology
Other areas of specialty/work
Street address
School of Medicine, Zand Blvd.
City
Shiraz
Postal code
Phone
+98 71 1230 7591
Fax
Email
mirkhanh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hossein Mirkhani
Position
Associate professor of pharmacology
Other areas of specialty/work
Street address
School of Medicine, Zand Blvd.
City
Shiraz
Postal code
Phone
+98 71 1230 7591
Fax
Email
mirkhanh@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)