Comparison of efficacy and side effects between Clopidogrel and Ticagrelor in patients with Acute ischemic stroke.
Design
unblinded randomized controlled clinical trial, phase 2 and 3, Tow arm parallel groups is conducted on 424 patients and simple random assignment method with the help of random numbers table.
Settings and conduct
This randomized controlled clinical trial will be conducted to compare the efficacy of Ticagrelor compared to Clopidogrel among patients with Acute ischemic stroke referred to Golestan Hospital, Ahvaz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of ischemic stroke or TIA based on history and neurological examination and imaging findings by a specialist.
Exclusion criteria:
More than 24 hours have passed since the onset of symptoms
Thrombolytic therapy or thrombectomy
Intracranial hemorrhage
Severe or moderate ischemic stroke (NIHSS>>12)
Intervention groups
Intervention: Aspirin (a loading dose of 300 mg on the first day followed by 80 mg once daily) with Ticagrelor (loading dose 180 mg) administered on day 1 and then 90 mg twice daily until day 30.
Control : Aspirin (a loading dose of 300 mg on the first day, then 80 mg once daily) plus Clopidogrel (300 mg), The loading dose is given on day 1, followed by 75 mg once daily until day 30.
Main outcome variables
Age; Gender; Body mass index; Underlying disease; Smoking; Lack of movement; Acute ischemic stroke; Type of treatment; Systolic/Diastolic blood pressure; Clinical complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012781N6
Registration date:2024-02-16, 1402/11/27
Registration timing:registered_while_recruiting
Last update:2024-02-16, 1402/11/27
Update count:0
Registration date
2024-02-16, 1402/11/27
Registrant information
Name
ِِDavood Kashipazha
Name of organization / entity
Ahvaz JodndiShapour University of Medical Sciencs
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3012
Email address
kashi-d@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-04, 1402/11/15
Expected recruitment end date
2024-08-05, 1403/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of Ticagrelor and Clopidogrel in patients with acute ischemic stroke or transient ischemic attack(TIA)
Public title
Comparing the efficacy of Ticagrelor and Clopidogrel in patients with Acute ischemic attack or Transient ischemic attack(TIA)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosing Ischemic Stroke or TIA based on history and neurological examination and Imaging findings by a Specialist
Exclusion criteria:
More than 24 hours have passed since the onset of symptoms
Thrombolytic therapy or Thrombectomy
Intracranial hemorrhage
Vascular malformations
The presence of contraindications to Aspirin, Clopidogrel or Ticagrelor
Severe or moderate Ischemic Stroke (NIHSS>>12)
Lack of patient consent to enter the study
The presence of acute coronary syndrome at the beginning of hospitalization
cardioembolic Stroke or TIA
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
424
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple random allocation, Individual randomization: unit, Randomization tool including Random numbers table
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
Reserch Ethics Committees of Ahvaz Jundishapur of University of Medical Sciences
Street address
Ahvaz, Golestan region, Farvardin Street, Golestan Hospital, Department of Neurology
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Approval date
2024-01-13, 1402/10/23
Ethics committee reference number
IR.AJUMS.REC.1402.551
Health conditions studied
1
Description of health condition studied
Acute Ischemic Stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Recurrence of stroke
Timepoint
21 days, 3 months, 6 months from the beginning of the study
Method of measurement
Clinical history and in case of recurrence of stroke symptoms, imaging findings.
Secondary outcomes
1
Description
Intracranial hemorrhage, Dyspnea, Mortality
Timepoint
21 days, 3 months, 6 months from the beginning of the study.
Method of measurement
Clinical history and Imaging findings in case of Symptoms related to Intracranial hemorrhage or Dyspnea.
Intervention groups
1
Description
Intervention group: (Ticagrelor/Aspirin): Aspirin (a loading dose of 100-300 mg as one to three tablets of 100 mg on the first day and then 80 mg once a day) together with Ticagrelor (loading dose of 180 mg ) is prescribed as two tablets of 90 mg on day 1 and then 90 mg twice a day until day 30.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Neurology of Golestan hospital
Full name of responsible person
Davood kashipazha
Street address
Farvardin Ave., Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357331118
Phone
+98 61 3320 4531
Email
dakashi47@ gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Esfand Ave., Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
http://vchresearch.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Alwanian
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Ahvaz, Golestan region, Farvardin Street, Golestan Hospital, Department of Neurology
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3320 4531
Email
dr.maryamalwanian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Alwanian
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Ahvaz, Golestan region, Farvardin Street, Golestan Hospital, Department of Neurology
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3320 4531
Email
dr.maryamalwanian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Alwanian
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Ahvaz, Golestan region, Farvardin Street, Golestan Hospital, Department of Neurology
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3320 4531
Email
dr.maryamalwanian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The primary clinical outcome of participants will be shared by the analysis of collected data.
When the data will become available and for how long
6 months after publication of results
To whom data/document is available
available for people who working in academic institutions
Under which criteria data/document could be used
Primary clinical outcome of participants will be shared by tables and charts.
From where data/document is obtainable
Davood kashipazha _ Department of Neurology of Golestan Hospital in Ahvaz. Email: dakashi47@gmail.com
What processes are involved for a request to access data/document
Please your request will be send by email. our response will be send you by email during a month.