The aim of this study is to evaluate the efficacy of allopurinol in preventing contrast induced nephropathy. Inclusion criteria is admission for elective PCI and exclusion criteria is serum creatinin>3mg/dL or eGFR<60ml/min; sever hepatic failure; concomitant use of 6mercaptopurin or azathioprine or warfarin. The study population is all patients admitted for elective PCI in Tehran Heart Center and the sample size is 200. 24 hours before PCI, blood samples are drawn to measure serum creatinin, uric acid, and serum cystatin C. After that patients are grouped in two groups-placebo and intervention. Patients in the intervention group receive two doses of 600mg allopurinol, one 24 hours and one immediately before the procedure. The control group will receive the placebo at these times. 24 hours after the procedure, another blood sample will be drawn to measure serum creatinin, uric acid, and serum cystatin C. The rate of contrast induced nephropathy will be compared between the two groups using aforementioned biomarkers. Also, adverse drug reactions will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120525372N1
Registration date:2017-06-06, 1396/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-06, 1396/03/16
Registrant information
Name
Zahra Alimohammad Ghelichkhan
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8840 0871
Email address
z-ghelichkhan@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
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 allopurinol in preventing contrast induced nephropathy among patients undergoing elective PCI
Public title
Effect of allopurinol in preventing kidney damage due to coronary angiography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients undergoing elective PCI
Exclusion criteria: Patients who are candidates for CABG or primary PCI; Patients with gout or prior use of allopurinol; Serum creatinin >3mg/dL or eGFR<60ml/min; Advanced hepatic failure; Patients who are using azathioprine, 6MP, or warfarin; Patients who have not filled/signed consent form, or the ones who had shown adverse reaction to the drug in prior use
Age
From 18 years old
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
149384-28024-159-01-94
Health conditions studied
1
Description of health condition studied
contrast induced nephropathy
ICD-10 code
Y57.5
ICD-10 code description
X-ray contrast media
Primary outcomes
1
Description
serum cystatin C
Timepoint
24 hours after PCI
Method of measurement
blood sample
2
Description
serum creatinin
Timepoint
24 hours after PCI
Method of measurement
blood sample
Secondary outcomes
1
Description
serum uric acid
Timepoint
24 hours before and after PCI
Method of measurement
blood sample
Intervention groups
1
Description
allopurinol, 600 mg PO, 24 hours before PCI
Category
Treatment - Drugs
2
Description
placebo, 24 hours before PCI
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Zahra Alimohammad Ghelich Khan
Street address
Clinical Pharmacy Dept., School of Phramacy, Tehran University of Medical Sciences
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yunesian
Street address
North Kargar-Ave
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
Full name of responsible person
Azita Hajhossein Talasaz
Position
Clinical Pharmacist
Other areas of specialty/work
Street address
Tehran, Tehran Heart Center
City
Tehran
Postal code
Phone
+98 21 8802 9610
Fax
Email
ahhtalasaz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azita Hajhossein Talasaz
Position
PhD
Other areas of specialty/work
Street address
clinical pharmacy department,school of pharmacy,Tehran university of medical sciences
City
tehran
Postal code
Phone
+98 21 8802 9256
Fax
Email
ahhtalasaz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Zahra Alimohammad Ghelich Khan
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 8840 0871
Fax
Email
z.gkhan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)