Efficacy of Ticagrelor Plus Aspirin in Mild Non-cardioembolic Ischemic Stroke (TACAMINIS)
Primary Purpose
Ischemic Stroke, Transient Ischemic Attack
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ticagrelor 90mg
Clopidogrel 75 mg
Sponsored by
About this trial
This is an interventional prevention trial for Ischemic Stroke focused on measuring minor stroke, secondary prevention, ticagrelor, aspirin, recurrence, non-cardioembolic, antiplatelet
Eligibility Criteria
Inclusion Criteria:
- signing inform consent,
- recent ischemic stroke within 24 h,
- diagnosed by brain CT or MRI mild stroke (non lacunar) 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
Sites / Locations
- Athena Sharifi Razavi
- Bou-Ali Sina hospital , Mazandarn University of Medical Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intervention
control
Arm Description
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.
control group 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.
Outcomes
Primary Outcome Measures
ischemic stroke recurrence
recording new event based on new lesion on brain CT scan or MRI
Secondary Outcome Measures
Major hemorrhagic event
Major bleeds were defined according to the International Society of Thrombosis and Hemostasis (ISTH)
ischemic stroke recurrence
recording new event based on new lesion on brain CT scan or MRI
cardiovascular events
any proven cardiovascular event
Full Information
NCT ID
NCT04738097
First Posted
January 31, 2021
Last Updated
October 18, 2023
Sponsor
Mazandaran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04738097
Brief Title
Efficacy of Ticagrelor Plus Aspirin in Mild Non-cardioembolic Ischemic Stroke
Acronym
TACAMINIS
Official Title
Ticagrelor Plus Aspirin vs Clopidogrel Plus Aspirin in Mild Non-cardioembolic Ischemic Stroke: A Randomized, Active Comparator Arm, Outcome Assessor Blind, Controlled, Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 8, 2021 (Actual)
Primary Completion Date
October 10, 2023 (Actual)
Study Completion Date
October 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mazandaran University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized, controlled, active comparator arm, outcome assessor blind, parallel group design on 90 patient with diagnosis of ischemic stroke admitted in Bou-Ali Sina Hospital, Sari,Iran.The aim of study is assess the efficacy of ticagrelor plus aspirin in reduce of minor non-cardioembolic ischemic stroke or high risk TIA recurrence during first 3 months.
Detailed Description
This is a randomized, controlled, parallel, active comparator arm, outcome assessor blind, feasibility study. The aim of study is assess the efficacy of ticagrelor plus aspirin in reduce of minor non-cardioembolic ischemic stroke or high risk TIA recurrence during first 3 months after primary event. 90 patient with diagnosis of ischemic stroke admitted in Bou-Ali Sina Hospital, Sari, Iran will be randomized to intervention or control group by using 4 block randomization method. Inclusion criteria is : age>40, signing inform consent, recent ischemic stroke within 24 h, diagnosed by brain CT or MRI mild stroke with NIHSS =<8 and no evidence of large infarct in brain imaging.,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 is :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 diathesis during randomization. Patients in control group will be treat with standard minor ischemic stroke regiment including 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. Three fallow up visit plan by a neurologist or neurology resident on month 1 and 3.Clinical data including NIHSS score, MRS score and other data will record on case report form. Stroke recurrence or cardiovsacular event is efficacy end point. Major bleeding according to STIH criteria is study safety end point. Primary outcome is ischemic stroke recurrence during first 3 months after first event documented by new lesion on brain CT or MRI. Secondary outcome is major hemorrhagic events, stroke recurrence during first 30 days and any cardiovascular event during first 3 month.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Transient Ischemic Attack
Keywords
minor stroke, secondary prevention, ticagrelor, aspirin, recurrence, non-cardioembolic, antiplatelet
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
Active Comparator
Arm Description
control group 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 Type
Drug
Intervention Name(s)
Ticagrelor 90mg
Other Intervention Name(s)
Ticer
Intervention Description
ASA 325 mg stat and ticagrelor 180 mg stat, then ASA 80 mg daily and ticagrelor 90 mg BID for 21 days.Treatment will be continue with ASA 80 until 3 months.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel 75 mg
Other Intervention Name(s)
Osvix
Intervention Description
ASA 325 mg stat and clopidogrel 300 mg stat, then ASA 80 mg and clopidogrel 75 mg daily for 21 days.Treatment will be continue with ASA 80 until 3 months.
Primary Outcome Measure Information:
Title
ischemic stroke recurrence
Description
recording new event based on new lesion on brain CT scan or MRI
Time Frame
first 3 months after first event
Secondary Outcome Measure Information:
Title
Major hemorrhagic event
Description
Major bleeds were defined according to the International Society of Thrombosis and Hemostasis (ISTH)
Time Frame
during first 30 days
Title
ischemic stroke recurrence
Description
recording new event based on new lesion on brain CT scan or MRI
Time Frame
first 1 month after first event
Title
cardiovascular events
Description
any proven cardiovascular event
Time Frame
during first 3 months after first event
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
signing inform consent,
recent ischemic stroke within 24 h,
diagnosed by brain CT or MRI mild stroke with NIHSS =<8 and no evidence of large infarct in brain imaging
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 diathesis during randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athena Sharifi-Razavi
Organizational Affiliation
Mazandaran University of Medical science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Athena Sharifi Razavi
City
Sari
State/Province
Mazandaran
ZIP/Postal Code
4818777111
Country
Iran, Islamic Republic of
Facility Name
Bou-Ali Sina hospital , Mazandarn University of Medical Science
City
Sari
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared by request to principal investigator for scientifical reseasons
IPD Sharing Time Frame
6 months after publishing study results
IPD Sharing Access Criteria
requested by a scientifically person, who plan for similar protocol study
Links:
URL
https://www.neurology-asia.org/articles/neuroasia-2023-28(3)-535.pdf
Description
published study protocol article
Learn more about this trial
Efficacy of Ticagrelor Plus Aspirin in Mild Non-cardioembolic Ischemic Stroke
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