The aim of this randomized clinical trial study is evaluation of high dose allopurinol effect on cardiac biomarkers (CKMB, CTnT) and Malondialdehyde (oxidative stress marker) before and after elective PCI. All patients with coronary heart disease (based on coronary angiography) who are referred for elective PCI enrolled; and patients who are candidates for CABG or Primary PCI, Glomerular filtration rate less than 60 ml / min or serum creatinine more than 3 mg / dl, history of gout, taking allopurinol, severe liver disease, or concomitant use of azathioprine, 6 - mercaptopurine or warfarin will excluded. All patients after filing consent will be divided into two groups: 100 patients receiving allopurinol (intervention group) and 100 patients receiving placebo (control group). One day before and the day of PCI, allopurinol 600 mg orally will be given to intervention group and placebo to other group. Levels of cardiac biomarkers after PCI will also be assessed. Then, level of cardiac biomarkers in before and after PCI in both groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210018698N1
Registration date:2012-11-03, 1391/08/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-03, 1391/08/13
Registrant information
Name
Azita Hajhossein Talasaz
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66954709
Email address
atalasaz@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Heart Center. Tehran University of Medical Sciences.
Expected recruitment start date
2012-10-13, 1391/07/22
Expected recruitment end date
2014-09-01, 1393/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of high dose allopurinol on cardiac biomarkers (CTnT, CKMB) in patients undergoing elective percutaneous coronary intervention
Public title
Effect of allopurinol on cardiac biomarkers in patients undergoing elective percutaneous coronary intervention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients who are candidates for elective PCI.
Exclusion criteria: patients who are candidates for CABG or Primary PCI; Glomerular filtration rate less than 60 ml / min or serum creatinine more than 3 mg / dl; history of gout; taking allopurinol; severe liver disease; concomitant use of azathioprine, 6 - mercaptopurine or warfarin.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Heart Center Hospital
Street address
Tehran, Kargar-e- shomali st.
City
Tehran
Postal code
1411713138
Approval date
2012-08-16, 1391/05/26
Ethics committee reference number
319/م ت
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
CTnT
Timepoint
before of intervention, one day after intervention
Method of measurement
ng/ml
2
Description
CKMB
Timepoint
before of intervention, one day after intervention
Method of measurement
ng/ml
Secondary outcomes
empty
Intervention groups
1
Description
Allopurinol 600 mg orally will be given to intervention group in two separated doses: first dose will be given one day before PCI and second dose given in the day of PCI.
Category
Treatment - Drugs
2
Description
Placebo orally will be given to control group in two separated doses: first dose will be given one day before PCI and second dose given in the day of PCI.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center Hospital
Full name of responsible person
Mohammad Javad Alemzadeh-Ansari
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh saaidi
Street address
16 Azar st, Tehran
City
Tehran
Grant name
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 Hospital
Full name of responsible person
Mohammad Javad Alemzadeh-Ansari
Position
Resident of Cardiology
Other areas of specialty/work
Street address
North Kargar-Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 8802 9600
Fax
Email
mj.aansari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Hamid Reza Pourhoseini
Position
Associate Professor
Other areas of specialty/work
Street address
North Kargar-Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 8802 9600
Fax
Email
hrph2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Heart Center Hospital, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Javad Alemzadeh-Ansari
Position
Resident of Cardiology
Other areas of specialty/work
Street address
North Kargar-Ave, Tehran
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9731
Email
mj.aansari@gmail.com
Web page address
http://thc.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)