Preventive effect of pretreatment with Intravenous nicorandil VS atorvastatin on contrast-Induced nephropathy in patients with normal renal function undergoing coronary angiography
Preventive effect of pretreatment with Intravenous nicorandil VS atorvastatin on contrast-Induced nephropathy in patients with normal renal function undergoing coronary angiography
Design
En In this interventional study, 128 pationts who are candidates for coronary angiography will be selected and divided into two groups using block randomization method (n=64 in each group). Proper counseling will be done and a written informed consent will be obtained before starting the treatment regimen.
Settings and conduct
En This study will be conducted in the form of double blind in Emam khomeini Hospital of Ardebil, Iran. Patients and clinical evaluators will be unaware of the type of medication they are receiving. The desired variables will be compared in patients undergoing coronary angiography with Nicurandyl and atorvastatin.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Coronary angiography, normal renal function . Exclusion criteria: Sensitivity to contrast agent.
Intervention groups
First intervention group: Atorvastatin 80 mg will be used for 3 days before and two days after angiography ( Tolidaru Co, Iran). Second intervention group: 10 mg of Nicorandil will be taken daily before 30 minutes to 2 days after angiography ( Bluepharma Co, Portugal).
Main outcome variables
Nephropathy due to contrast subjects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150808023559N22
Registration date:2020-05-20, 1399/02/31
Registration timing:prospective
Last update:2020-05-20, 1399/02/31
Update count:0
Registration date
2020-05-20, 1399/02/31
Registrant information
Name
Somaieh Matin
Name of organization / entity
Ardabil University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3011
Email address
s.matin@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preventive effect of pretreatment with Intravenous nicorandil VS atorvastatin on contrast-Induced nephropathy in patients with normal renal function undergoing coronary angiography
Public title
Effect of pretreatment nicorandil VS atorvastatin on contrast-Induced nephropathy in patients with normal renal function
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Coronary angiography
Normal renal function
Exclusion criteria:
Sensitivity to contrast agent
Age
From 18 years old to 75 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned randomly by blocking in one of the two specified groups and after selecting the envelope for each patient, before starting the treatment regimen envelope will be opened and based on the protocol, one of two methods will be selected.
Blinding (investigator's opinion)
Double blinded
Blinding description
Packages containing the drugs are given to patients in code A and B, and neither patients nor outcome assessors will know the contents of the package.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medicine Sciences, Daneshgah street, Ardabil
City
ARDABIL
Province
Ardabil
Postal code
5615783134
Approval date
2020-03-29, 1399/01/10
Ethics committee reference number
Ir.arums.rec.1399.013
Health conditions studied
1
Description of health condition studied
Nephropathy
ICD-10 code
N14.1
ICD-10 code description
Nephropathy induced by other drugs, medicaments and biological substances
Primary outcomes
1
Description
Nephropathy due to contrast subjects
Timepoint
24 and 48 hours after angiography
Method of measurement
Measurement of serum creatinine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Atorvastatin 80 mg will be used for 3 days before and two days after angiography
Category
Diagnosis
2
Description
Control group: 10 mg of Nicorandil will be taken daily before 30 minutes to 2 days after angiography