Acute ischemic stroke (AIS) is one of common diseases with significant morbidity, mortality and disability. A wide array of studies confirms that intravenous thrombolytic therapy with alteplase can effectively improve the functional prognosis in acute ischemic stroke. Thus all guidelines recommended the intravenous thrombolytic therapy with alteplase for acute ischemic stroke within 4.5 hours from stroke onset. Minor stroke is usually defined as NIHSS score ≤ 3 or 5,although it accounts for 1/2-2/3 of AIS, the evidence of thrombolysis is insufficient. A study from Canada shows that 28.5% of patients with minor stroke who have not receive rt-pa thrombolytic therapy are unable to walk independently when discharged. Based on such a consideration,the PRISMS study further compares the efficacy and safety of thrombolytic therapy with antithrombotic therapy in patients with minor stroke. Unfortunately, the study has been early terminated due to the sponsorship reason in 2018, with only 313 cases enrolled. The preliminary results shows that there is no significant difference of the 90-day neurological function between the two groups, while the safety of the treatment group with alteplase has a higher rate of symptomatic intracranial hemorrhage. The patient receiving thrombolysis can not be given antithrombolytic therapy within 24 hours even if the patient's condition has worsened, is clinically more puzzling. The CHANCE study in 2013 shows that the efficacy of aspirin with clopidogrel is superior to aspirin alone with minor stroke (NIHSS \< 3) or TIA(ABCD2 \< 4). The POINT study in 2018 further confirmed the efficacy and safety of intensive antithrombotic therapy within 12 hours of onset with minor stroke. Based on the above discussion, this study aims to explore the efficacy and safety of aspirin with clopidogrel vs alteplase in the treatment of acute minor stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
760
100mg qd
75mg(after first dose of 300mg)qd
Iv at 0.9 milligrams per kilogram (mg/kg)
Lin Tao
Shenyang, China
Proportion of mRS (0-1)
Time frame: 90±7 days
Proportion of mRS (0-2)
Time frame: 90±7 days
change in NIH Stroke Scale score compared with baseline
Time frame: 24 hours
incidence of early neurological improvement
more than 2 NIH Stroke Scale score decrease compared with baseline
Time frame: 24 hours
Incidence of early neurological deterioration
more than 2 NIH Stroke Scale score increase (not result of cerebral hemorrhage) compared with baseline
Time frame: 7 days
occurrence of stroke or other vascular events
Time frame: 90±7 days
proportion of death of any cause
Time frame: 90±7 days
occurrence of symptomatic intracranial hemorrhage
more than 4 NIHSS score increase caused by intracranial hemorrhage
Time frame: 90±7 days
proportion of any bleeding events
Time frame: 90±7 days
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