In this study we aim to divide patients candidate for CABG at Tehran Heart Center in two randomized groups:
patients of group 1 will recieved 80 mg atorvastatin daily
patients of group 2 will recieved 40 mg atorvastatin daily
(Atorvastatin will begin since 5 days before surgeries.)
we will compare 8 and 24 hours post-CABG CKMB and high sensitive cTnT and other short-term outcomes (AF incidence rates, ICU addmission hours, CVA/TIA, and etc) between the two groups.
Intervention (atorvastatin use) duration: 5 days
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112231024N1
Registration date:2017-05-06, 1396/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-06, 1396/02/16
Registrant information
Name
Arash Shekari
Name of organization / entity
Tehran Heart Center / Tehran University of Medical Scienes
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9600
Email address
a-shekari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Heart Center
Expected recruitment start date
2017-05-01, 1396/02/11
Expected recruitment end date
2017-06-01, 1396/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
High dose atorvastatin effects on cardiac biomarkers (24 hours after CABG): 80 mg vs 40 mg
Public title
High dose atorvastatin effects on cardiac biomarkers (24 hours after CABG)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: admission for CABG in Tehran Heart Center.
Exclusion criteria: other heart surgeries; COPD; emergent surgeries; liver insufficiency; renal dysfunction ( Cr > 1.5); MI (myocardial infarction) since recent 6 weeks; age > 75 years old.
Age
To 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
118
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
Tehran Heart Center ethics committe
Street address
Tehran Heart Center, north kargar street, jalal al ahmad cross, Tehran, Iran
City
Tehran
Postal code
Approval date
2017-04-30, 1396/02/10
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.2174
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
CKMB and high sensitive cTnT 24 hours after CABG
Timepoint
24 hours before and 8 and 24 hours after CABG
Method of measurement
CKMB and high sensitive cTnT (ELIZA)
Secondary outcomes
empty
Intervention groups
1
Description
patients of group 1 will recieved 80 mg atorvastatin daily for 5 days
Category
Treatment - Drugs
2
Description
patients of group 2 will recieve 40 mg atorvastatin daily for 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
arash shekari
Street address
Tehran Heart Center, North Kargar street, Jalal al Ahmad cross
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research (Dr masud Yunesian)
Street address
Vice Chancellor for Research, 6th floor, Tehran University of Medical Sciences, Qods street, Keshavarz Avenue
City
tehran
Grant name
طرح به عنوان پایان نامه برای اخذ دکترای تخصصی قلب و عروق تصویب شده است
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran Heart Center
Full name of responsible person
Arash Shekari
Position
MD, resident of cardiology
Other areas of specialty/work
Street address
Tehran Heart Center, North Kargar street, Jalal al Ahmad cross
City
Tehran
Postal code
Phone
+98 21 8802 9600
Fax
Email
a-shekari@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Arash Shekari
Position
MD, resident of cardiology
Other areas of specialty/work
Street address
Tehran Heart Center, North Kargar street, Jalal al Ahmad cross
City
Tehran
Postal code
Phone
+98 21 8802 9600
Fax
Email
a-shekari@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Arash Shekari
Position
MD, resident of cardiology
Other areas of specialty/work
Street address
Tehran Heart Center, North Kargar street, Jalal al Ahmad cross
City
Tehran
Postal code
Phone
+98 21 8802 9600
Fax
Email
a-shekari@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)