Investigation the effect of oral nicorandil on arrhythmia rate in patients undergoing angioplasty
Design
Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 100 patients with myocardial infarction
Settings and conduct
This study will be conducted with the aim of investigation the effect of nicorandil on arrhythmia rate in 100 patients with myocardial infarction. After inclusion in the study, using block randomization method with blocks of ten, the patients will be assigned into two groups; intervention group receiving 20 mg oral nicorandil twice a day since admission till discharge and control group receiving nicorandil placebo twice a day since admission till discharge. In each group arrhythmia rate will be evaluated by taking electrocardiogram and its evaluation by cardiologist and will be compared together.
Participants/Inclusion and exclusion criteria
Inclusion criterion: having a definite diagnosis of myocardial infarction.
Exclusion criteria: cardiogenic shock; previous use of nicorandil; undergoing cardiopulmonary resuscitation
Intervention groups
Intervention group: Receiving 20 mg nicorandil orally twice a day since admission till discharge
Control group: Receiving nicorandil placebo twice a day since admission till discharge
Main outcome variables
Arrhythmia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181104041555N1
Registration date:2018-12-13, 1397/09/22
Registration timing:prospective
Last update:2018-12-13, 1397/09/22
Update count:0
Registration date
2018-12-13, 1397/09/22
Registrant information
Name
Hesam Mullazehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
h.mullazehi.med@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of oral nicorandil on arrhythmia rate in patients undergoing angioplasty
Public title
The effect of nicorandil on arrhythmia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a definite diagnosis of myocardial infarction
Exclusion criteria:
Cardiogenic shock
Previous use of nicorandil
Undergoing cardiopulmonary resuscitation
Age
From 20 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of 10.
The patients will be randomly assigned into 2 groups of 50. Considering the sample size of 100 (50 patients in nicorandil group and 50 patients in placebo group) , 10 blocks with 10 people will be selected; in each block there will be 5 cards of nicorandil group and 5 cards of placebo group. So by selecting each block, 5 people will be assigned into each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient's physician wont be aware of patients assignment into study groups. Drug and placebo will be similar in shape and size; so the patients are blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Approval date
2018-02-07, 1396/11/18
Ethics committee reference number
IR.ZAUMS.REC.1396.356
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Arrhythmia
Timepoint
After angiography for 48 hours
Method of measurement
By evaluating the electrocardiogram by cardiologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving 20 mg nicorandil orally twice a day since admission till discharge
Category
Treatment - Drugs
2
Description
Control group: Receiving nicorandil placebo twice a day since admission till discharge
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital
Full name of responsible person
Hesam Mullazehi
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
h.mullazehi.med@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
Dr.Taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Hesam Mullazehi
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Fax
Email
h.mullazehi.med@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hesam Mullazehi
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Fax
Email
h.mullazehi.med@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hesam Mullazehi
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Fax
Email
h.mullazehi.med@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available