TACAMINIS: Efficacy of Ticagrelor Plus Aspirin in Minor Non-cardioembolic Ischemic Stroke

Sponsor

Mazandaran University of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04738097

Collaborator

(none)

Enrollment

Locations

Arms

15.8

Anticipated Duration (Months)

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke Transient Ischemic Attack	Drug: Ticagrelor 90mg Drug: Clopidogrel 75 mg	Phase 3

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,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 diatesis 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 cardiovacular event is efficacy end point. Major bleeding according to STICH 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Ticagrelor Plus Aspirin vs Clopidogrel Plus Aspirin in MInor Non-cardioembolic Ischemic Stroke: A Randomized, Active Comparator Arm, Outcome Assessor Blind, Conrolled, Feasibility Study

Actual Study Start Date :

Aug 8, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention 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.	Drug: Ticagrelor 90mg 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. Other Names: Ticer
Active Comparator: control control 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.	Drug: Clopidogrel 75 mg 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. Other Names: Osvix

Arm

Intervention/Treatment

Experimental: intervention

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.

Drug: Ticagrelor 90mg

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.

Other Names:

Ticer

Active Comparator: control

control 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.

Drug: Clopidogrel 75 mg

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.

Other Names:

Osvix

Outcome Measures

Primary Outcome Measures

ischemic stroke recurrence [first 3 months after first event]
recording new event based on new lesion on brain CT scan or MRI

Secondary Outcome Measures

Major hemorrhagic event [during first 30 days]
Major bleeds were defined according to the International Society of Thrombosis and Hemostasis (ISTH)
ischemic stroke recurrence [first 1 month after first event]
recording new event based on new lesion on brain CT scan or MRI
cardiovascular events [during first 3 months after first event]
any proven cardiovascular event

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Athena Sharifi Razavi	Sari	Mazandaran	Iran, Islamic Republic of	4818777111
2	Bou-Ali Sina hospital , Mazandarn University of Medical Science	Sari		Iran, Islamic Republic of