Clinical Research Directory

Early Low-dose ASpirin Use After Intravenous Thrombolysis for Acute Ischemic Cerebral Infarction（ELASTIC）

Sponsor: Beijing Chao Yang Hospital

Summary

Intravenous thrombolysis is the most effective method for the very early treatment of acute cerebral infarction. In order to prevent symptomatic intracranial hemorrhage (SICH), domestic and foreign guidelines recommend starting antiplatelet therapy 24 hours after thrombolysis, but this recommendation is not based on prospective clinical studies. Several studies have shown that 14-34% of recanalization arteries will be re-occluded in a short period of time after thrombolysis. Re-occlusion is mainly caused by platelet accumulation and is closely related to disease deterioration and poor prognosis. On the other hand, the average incidence of SICH is 2.4%, and the proportion of fatal SICH is only 0.28%. Therefore, the impact of re-occlusion on poor prognosis is much greater than that of SICH. This study adopts a prospective randomized controlled open design, and patients with acute cerebral infarction who receive intravenous thrombolysis are randomly divided into two groups: the treatment group starts aspirin 100mg antiplatelet therapy 2 hours after thrombolysis; The control group was given aspirin antiplatelet therapy 24 hours after thrombolysis as usual. The main evaluation indicator was the proportion of good prognosis (mRS score 0\~2 points) at 3 months; the safety evaluation indicators were the incidence of SICH and the case fatality rate of patients at 3 months. Through this study, we intend to evaluate whether early use of aspirin after thrombolysis can improve the prognosis. This study will provide direct clinical evidence for the pros and cons of early initiation of antiplatelet therapy after thrombolysis in patients with cerebral infarction.

Official title: Safety and Efficacy of Treatment With Early Low-dose ASpirin Use After Intravenous Thrombolysis for Acute Ischemic Cerebral Infarction (ELASTIC): A Randomized, Open-label, Blinded Endpoint, Clinical Trial

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