This is a randomized, controlled, parallel, outcome assessor blind, feasibility study.
The aim of study is assess the efficacy of ticagrelor de-escalation in reduce of
non-disabling non-cardioembolic ischemic stroke or high risk TIA recurrence during first
12 months after primary event. 100 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 ischemic stroke regiment including ASA 325 mg stat and ticagrelor 180 mg stat,
then ASA 80 mg and ticagrelor 90 mg BID for 1 month. Then single antiplatelet therapy
with ASA will be continue. 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 1 month. And,
Ticagrelor 60 mg BID plus ASA 80 mg daily until the end of month 3. Then single
antiplatelet therapy with ASA will be continue. Four fallow up visit plan by a
neurologist or neurology resident on month 1, 3, 6 and 12.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 12
months after first event documented by new lesion on brain CT or MRI. Secondary outcome
is major hemorrhagic events, stroke recurrence during first 3 months and any
cardiovascular event during first 12 month.