Treatment effect of aspirin with and without Clopidogrel on prevention of transient ischemic attack or acute minor stroke in patients with transient ischemic attack: a randomized clinical trial
To assess the treatment effect of aspirin with and without Clopidogrel on prevention of transient ischemic attack or acute minor stroke in patients with transient ischemic attack
Design
This is a randomized clinical trial, phase II, in which 54 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with transient ischemic attack who will refer to Sina Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
age between18 to 80 years old; transient ischemic attack; severity of stroke score less than 15.
Exclusion criteria:
gastric disorders; cardiac arrhythmia; sensitivity of aspirin; candidate for carotid introversion.
Intervention groups
Intervention group: Aspirin tablet 81 mg/day for 3 months plus Clopidogrel tablet 75 mg/day for 3 months
Control group: Aspirin tablet 81 mg/day for 3 months
Main outcome variables
Primary outcome:
transient ischemic attack; acute minor stroke
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N232
Registration date:2018-08-27, 1397/06/05
Registration timing:registered_while_recruiting
Last update:2018-08-27, 1397/06/05
Update count:0
Registration date
2018-08-27, 1397/06/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment effect of aspirin with and without Clopidogrel on prevention of transient ischemic attack or acute minor stroke in patients with transient ischemic attack: a randomized clinical trial
Public title
Treatment effect of aspirin with and without Clopidogrel on prevention of transient ischemic attack or acute minor stroke in patients with transient ischemic attack
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 80 years;
Transient ischemic attack;
Severity of stroke score less than 15
Exclusion criteria:
Gastric disorders;
Cardiac arrhythmia;
Sensitivity of aspirin;
Candidate for Carotid introversion
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.UMSHA.REC.1397.301
Health conditions studied
1
Description of health condition studied
Transient ischemic attack
ICD-10 code
G45.9
ICD-10 code description
Transient cerebral ischemic attack, unspecified
Primary outcomes
1
Description
Transient ischemic attack
Timepoint
3 months after intervention
Method of measurement
With physical examination and history taking
2
Description
Acute minor stroke
Timepoint
3 months after intervention
Method of measurement
With physical examination and history taking
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aspirin tablet 81 mg/day for 3 months plus Clopidogrel tablet 75 mg/day for 3 months
Category
Treatment - Drugs
2
Description
Control group: Aspirin tablet 81 mg/day for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Fatemeh Ghasemian
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
dr.sahel.72@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Ghasemian
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
dr.sahel.72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Khazaei
Position
Neurologist
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
khazaeimojtaba@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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
Undecided - It is not yet known if there will be a plan to make this available
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