Protocol summary

Study aim
To assess the efficacy of ticagrelor plus aspirin in comparison with clopidogrel plus aspirin in reduce of minor non-cardioembolic ischemic stroke or high risk TIA recurrence during first 3 months
Design
A randomized, controlled, active comparator arm, outcome assessor blind, parallel group design on 90 ischemic stroke patients with block randomization method
Settings and conduct
This is a randomized, controlled active comparator arm, outcome assessor blind on 90 patient with diagnosis of ischemic stroke admitted in Bou-Ali Sina Hospital, Sari, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria: age>40, signing inform consent, recent ischemic stroke within 24 h, diagnosed by brain CT or MRI mild stroke with NIHSS =<8,high risk TIA with ABCD >4, no cardioembolic source such as low E/F, MS, AF ,... no specific etiology such as dissection, vasculitis, ... no carotid stenosis > 50 % in side of involvement Exclusion criteria:history of hypersensitivity to consumptive drug any indication for anticoagulant therapy acute phase treatment with intravenous thrombolysis or thrombectomy any contraindication for consumptive drug history of intracranial hemorrhage history of GI bleeding during past 6 m candidate for endarterectomy history of coagulopathy active hemorrhagic diatesis during randomization
Intervention groups
comparator gruop will be treat with ASA 325 mg stat and clopidogrel 300 mg stat, then ASA 80 mg and clopidogrel 75 mg daily for 21 days. intervention group will be treat with ASA 325 mg stat and ticagrelor 180 mg stat, then ASA 80 mg daily and ticagrelor 90 mg BID for 21 days. Then all groups will be treat with ASA 80 mg daily after day 21.
Main outcome variables
ischemic stroke recurrence during first 3 months and major bleeding event

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200112046094N2
Registration date: 2021-08-01, 1400/05/10
Registration timing: prospective

Last update: 2021-08-01, 1400/05/10
Update count: 0
Registration date
2021-08-01, 1400/05/10
Registrant information
Name
َAthena Sharifi-Razavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 3014
Email address
athena.sharifi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-07, 1400/05/16
Expected recruitment end date
2022-08-07, 1401/05/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ticagrelor plus Aspirin vs Clopidogrel plus Aspirin in MInor Non-cardioembolic Ischemic Stroke (TACAMINIS)
Public title
Ticagrelor in minor ischemic stroke
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
signing inform consent recent ischemic stroke within 24 h, diagnosed by brain CT or MRI mild stroke with NIHSS =<8 high risk TIA with ABCD >4 no cardioembolic source such as low E/F, MS, AF ,... no specific etiology such as dissection, vasculitis, ... no carotid stenosis > 50 % in side of involvement
Exclusion criteria:
history of hypersensitivity to consumptive drug any indication for anticoagulant therapy acute phase treatment with intravenous thrombolysis or thrombectomy any contraindication for consumptive drug history of intracranial hemorrhage history of GI bleeding during past 6 m candidate for endarterectomy history of coagulopathy active hemorrhagic diatesis during randomization
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
by using 4 block randomization method and random numbers table with 1:1 fasion
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
this protocol designed as outcome assessor blind. The comparator group is an active group and participants treated with standard drugs.

Secondary Ids

1

Registry name
(www.clinicaltrial.gov)مرکز ثبت کارآزمائي هاي باليني ايالات متحده آمريکا
Secondary trial Id
"NCT04738097 "for clinicaltrials.gov
Registration date
2021-02-04, 1399/11/16

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Deputy of research and technology, Moallem Sq
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
IR.MAZUMS.REC.1400.304

Health conditions studied

1

Description of health condition studied
ischemic stroke
ICD-10 code
ICD-10 code description

2

Description of health condition studied
transient ischemic attack
ICD-10 code
G45
ICD-10 code description
Transient cerebral ischemic attacks and related syndromes

Primary outcomes

1

Description
ischemic stroke recurrence during first 3 months after first event
Timepoint
3 months after first stroke event
Method of measurement
recording new event based on new lesion on brain CT scan or MRI

Secondary outcomes

1

Description
ischemic stroke recurrence during first 1 month
Timepoint
1 month after first evevnt
Method of measurement
recording recurrence based on new lesion on brain CT scan or MRI

2

Description
Major hemorrhagic event
Timepoint
during first 1 month
Method of measurement
Major bleeds were defined according to the International Society of Thrombosis and Hemostasis (ISTH)

3

Description
other cardiovascular events
Timepoint
during first 3 months
Method of measurement
recording proven cardiovascular event such as MI

Intervention groups

1

Description
Intervention group: Patients will be treat with ASA 325 mg stat and ticagrelor 180 mg stat , then ASA 80 mg daily and ticagrelor 90 mg BID for 21 days. Then ASA 80 mg daily will be continue.
Category
Prevention

2

Description
Control group: Patients will be treat with standard minor stroke treatment, ASA 325 mg stat and clopidogrel 300 mg stat , then ASA 80 mg daily and clopidorel 75 mg daily for 21 days. Then ASA 80 mg daily will be continue.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Bou-Ali Sina Hospital
Full name of responsible person
Athena Sharifi-Razavi
Street address
Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3014
Email
athena.sharifi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeidi
Street address
Deputy of research and technology, Moallem Sq
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
pajoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
َAthena Sharifi-Razavi
Position
َAssistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Bou Ali Sina hospital,Pasdaran Blvd.
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3014
Fax
Email
athena.sharifi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
َAthena Sharifi-Razavi
Position
َAssistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Bou Ali Sina hospital,Pasdaran Blvd.
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3014
Fax
Email
athena.sharifi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
َAthena Sharifi-Razavi
Position
َAssistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Bou Ali Sina hospital,Pasdaran Blvd.
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3014
Fax
Email
athena.sharifi@yahoo.com

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
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