Early antiplatelet treatment for minor stroke following thrombolysis: the EAST trial
Dawei Chen, Yu Cui, Xiaoqiu Li, Xinhong Wang, Changhao Jiang, Jing Li, Zhi-Mei Yuan, Liwei Zhao, Nan Kong, Hai-Ning Mi, Jiang Lu, Hong Zhang, Youjun Liu, Er-Qiang Wang, Yan Yan, Cheng-Guang Song, Yi Zhang, Shuyao Wang, Hongguo Dai, Yi Yang, Shi-Mei Geng, Rong Yin, Duolao Wang, Thanh N. Nguyen
Abstract
BACKGROUND AND AIMS: Antiplatelet treatment is recommended to start 24 h after intravenous thrombolysis due to concerns about haemorrhagic transformation. This study aimed to investigate the potential benefit of early antiplatelet after intravenous thrombolysis in minor stroke. METHODS: A multicentre, double-blind, randomized trial was conducted in China between 7 August 2022 and 1 August 2024, to evaluate the efficacy and safety of early antiplatelet in acute ischaemic stroke patients presenting with mild neurological deficits, as indicated by a National Institutes of Health Stroke Scale (NIHSS) score of 0-5, who received intravenous thrombolysis. Patients were randomly assigned to receive either clopidogrel and aspirin or placebo within 6 h after intravenous thrombolysis. The primary endpoint was an excellent functional outcome at 90 days, indicated by a modified Rankin Scale (mRS) score of 0-1. Statistical analysis was based on a modified intention-to-treat population. Symptomatic intracranial haemorrhage, any intracranial haemorrhage, and major systemic bleeding were safety endpoints. RESULTS: The primary endpoint was not met in this study. Of the randomly assigned 1022 patients, 995 patients were included in the modified intention-to-treat analysis (503 with early antiplatelet treatment and 492 with placebo). The primary endpoint occurred in 89.7% (451/503) of patients receiving early antiplatelet vs 89.6% (441/492) of those receiving placebo with no significant difference (odds ratio 1.00, 95% confidence interval .67-1.51, P = .99). Similar safety profiles were found between the two groups. CONCLUSIONS: Among Chinese patients with acute minor ischaemic stroke who received intravenous thrombolysis, early antiplatelet treatment with clopidogrel plus aspirin was safe but did not improve already excellent functional outcome (mRS 0-1) at 90 days.