Clinical trial NCT04738097: Efficacy of Ticagrelor Plus Aspirin in Mild Non-cardioembolic Ischemic Stroke
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Stroke
Transient Ischemic Attack
Keywords: minor stroke
secondary prevention
ticagrelor
aspirin
recurrence
non-cardioembolic
antiplatelet
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: ischemic stroke recurrence
timeFrame: first 3 months after first event
Secondary outcomes:
measure: Major hemorrhagic event
timeFrame: during first 30 days
measure: ischemic stroke recurrence
timeFrame: first 1 month after first event
measure: cardiovascular events
timeFrame: during first 3 months after first event
Other outcomes:
Locations:
city: Sari
country: Iran, Islamic Republic of
facility: Athena Sharifi Razavi
state: Mazandaran
city: Sari
country: Iran, Islamic Republic of
facility: Bou-Ali Sina hospital , Mazandarn University of Medical Science
Study officials:
affiliation: Mazandaran University of Medical science
name: Athena Sharifi-Razavi
role: PRINCIPAL_INVESTIGATOR
References: