Evaluation of efficacy of Nicorandil on incidence of contrast-induced nephropathy in patients with GFR < 60% and undergoing coronary angiography and percutaneous coronary intervention- A randomized clinical trial
Evaluation of efficacy of Nicorandil for prevention of contrast-induced nephropathy in patients undergoing coronary angiography and percutaneous coronary intervention
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial for 264 patients.
The website http://www.randomization.com/ will be used for randomization.
Settings and conduct
This study will be conducted on patients who are candidates for CAG or PCI in Heshmat Rasht Hospital
The study will be single blind and only the patients will be unaware of the treatment method of the other group.
Participants/Inclusion and exclusion criteria
Patients with GFR less than 60 who are not on dialysis and are candidates for non-emergenct CAG or non-primary PCI and have 24 hours of drug therapy with nicorandil will be included in the study.
And patients who have received metformin, ARB, ACEI, nicorandil, nitrocantine, sildenafil and other phosphodiesterase 5 (PDE5) inhibitor family drugs in the last 24 hours and have urinary tract infection will not be included in the study.
Intervention groups
In the control group, patients will be hydrated with 0.45% saline serum in the form of 50 cc per hour from 24 hours before the procedure to 24 hours after, and they will be given N-acetylcysteine 1200 mg orally every 12 hours. It will be given from 24 hours before to 24 hours after the procedure.
In the intervention group, patients will be hydrated with 0.45% saline serum in the form of 50 cc per hour from 24 hours before the procedure to 24 hours after, and they will be given 1200 mg N-acetylcysteine tablets orally every 12 hour from 24 hours before to 24 hours after the procedure. Also, in the intervention group, patients will receive Nicorandil 10 mg tablets every 12 hours from 24 hours before to 24 hours after the procedure.
Main outcome variables
Creatinine level- BUN level- urinary output
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230110057096N1
Registration date:2023-02-10, 1401/11/21
Registration timing:registered_while_recruiting
Last update:2023-02-10, 1401/11/21
Update count:0
Registration date
2023-02-10, 1401/11/21
Registrant information
Name
Arsalan Salari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
gums.icrc@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of Nicorandil on incidence of contrast-induced nephropathy in patients with GFR < 60% and undergoing coronary angiography and percutaneous coronary intervention- A randomized clinical trial
Public title
Effect of Nicorandil on contrast-induced nephropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with GFR<60 ml/min that do not undergo dialysis
Patients who are a candidate for non-emergent CAG or non-primary PCI and have 24-hour time for treatment with Nicorandil
Exclusion criteria:
Consuming Metformin, ACEI, ARB, Nicorandil, Nitrocontin, Sildenafil and other phosphodiesterase 5 inhibitors in the last 24 hours
having urinary tract infection(UTI)
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
264
Randomization (investigator's opinion)
Randomized
Randomization description
The method of sampling and randomization of this clinical trial study will be the blocked randomization method. In this way, each person will be randomly placed in the intervention and control group using blocks of 4 randomly in a ratio of 1:1. Letters A and B will be assigned to each group.
The website http://www.randomization.com/ will be used for randomization. The list of codes obtained from this website will be provided to the researchers of the project, and every patient who meets the conditions for entering the study will be entered into the study according to the assigned code A, B respectively.
For concealment in this research, simple random allocation concealment method will be used on the study participants. In this way, each patient will be assigned a code. In this method, each of the generated random codes will be written on a card. Then they will be placed inside sealed opaque envelopes in random order. In order to maintain the random sequence, the outer surface of the envelopes will be numbered in the same order. Finally, the lid of the letter envelopes will be glued and will be placed in a box respectively. At the time of sampling, based on the order of entry of qualified participants into the study, one of the envelopes will be revealed in the order of opening and the assigned group of that participant.
Blinding (investigator's opinion)
Single blinded
Blinding description
Our study will be one-sided blind. Due to ethical issues, we cannot hide the type of treatment from the patients, so the patients are aware of the type of treatment they will receive (being in the intervention or control group). But to avoid bias in the results, the outcome evaluator (data analyst) does not know which groups the patients belong to. The groups can be specified by coding so that the analyst does not understand.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in research of Guilan University of Medical Sciences
Street address
Vice President of Research and Technology of Guilan University of Medical Sciences, in front of 17sharivar Hospital,Shahid Siadati Ave., Namjoo Blvd., Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2022-12-21, 1401/09/30
Ethics committee reference number
IR.GUMS.REC.1401.504
Health conditions studied
1
Description of health condition studied
contrast-induced nephropathy
ICD-10 code
ICD 10- N1
ICD-10 code description
Nephropathy induced by other drugs, medicaments and biological substances
Primary outcomes
1
Description
creatinine level
Timepoint
Measuring level of creatinine on the days 0-3-5
Method of measurement
Creatinine measurement will be done with the help of a quantitative detection kit for creatinine in serum, plasma or urine with the photometric method of Pars Azmoun company and with the callimetric method without removing proteins based on the JAFFE method.
2
Description
BUN level
Timepoint
Measuring level of BUN on the days 0-3-5
Method of measurement
BUN will be measured with the help of Urea UV quantitative detection kit in serum, plasma and urine with the photometric method of Pars Azmoun company and with the enzyme method based on the Urease-GLDH method.
3
Description
urinary output
Timepoint
Measuring urinary output on the days 0-3-5
Method of measurement
The amount of urinary output is calculated by measuring the volume of a person's urine
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In the control group standardad treatment is used and we do not use placebo. as standard treatment tab NAC 1200 mg/po/BD is given to the patients. we also hydrate the patients with half saline 50cc/h from 24 hours before to 24 hours after the procedure . we use NAC from SanaMed pharmaceutical co.
Category
Prevention
2
Description
Intervention group: in the intervention group as standard treatment tab NAC 1200 mg/po/BD is given to the patients. we also hydrate the patients with half saline 50cc/h from 24 hours before to 24 hours after the procedure . also tab Nicorandil 10 mg/po/BD is given to the patients from 24 hours before to 24 hours after the procedure. we use NAC from SanaMed pharmaceutical co. and Nicorandil from rivopharm
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmat Hospital
Full name of responsible person
Arsalan Salari
Street address
Next to the management and planning organization of Gilan province, 15 khordad st, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 9064
Email
Gums.icrc@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
MohammadReza Naghi pour
Street address
Vice President of Research and Technology of Guilan University of Medical Sciences, in front of 17sharivar Hospital,Shahid Siadati Ave., Namjoo Blvd., Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 6395
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Arsalan Salari
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Next to the management and planning organization of Gilan province, 15 Khordad st., Rasht
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 9064
Email
gums.icrc@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Arsalan Salari
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Next to the management and planning organization of Gilan province, 15 Khordad st., Rasht
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 9064
Email
gums.icrc@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Arsalan Salari
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Next to the management and planning organization of Gilan province, 15 Khordad st., Rasht
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 9064
Email
gums.icrc@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After the start of the project, documentation will be sent by the project manager
When the data will become available and for how long
1 week
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
by SPSS
From where data/document is obtainable
Project Manager
What processes are involved for a request to access data/document
The project manager will email and send the documentation through SPSS within a week.