Efficacy of Ticagrelor Plus Aspirin in Mild Non-cardioembolic Ischemic Stroke

Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738097
• Other study ID #: 4164
• Status: Completed
• Phase: Phase 3
• Start date: August 8, 2021
• Est. completion date: October 15, 2023

Study information

• Verified date: October 2023
• Source: Mazandaran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 15, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Stroke
• Transient Ischemic Attack

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Athena Sharifi Razavi	Sari	Mazandaran
Iran, Islamic Republic of	Bou-Ali Sina hospital , Mazandarn University of Medical Science	Sari

Sponsors (1)

Lead Sponsor	Collaborator
Mazandaran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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

External Links

•   published study protocol article