Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke
Status:
Recruiting
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
Summary
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.