Department of Neurology, General Hospital of Northern Theater Command, Shenyang, China.
Int J Stroke. 2023 Jun;18(5):615-619. doi: 10.1177/17474930221118900. Epub 2022 Aug 24.
Early neurological deterioration (END) occurs in about 10% of patients after intravenous thrombolysis (IVT) and is related to poor outcome. In theory, early antiplatelet following IVT could reduce END by preventing re-occlusion and stroke progression, but current guidelines recommend starting antiplatelet treatment at 24 h after IVT due to concerns about hemorrhagic transformation. Given higher risk of hemorrhagic transformation in severe stroke, we hypothesized that minor stroke patients following IVT can safely benefit from early antiplatelet treatment.
To explore the efficacy and safety of early antiplatelet in minor stroke patients after IVT.
A maximum of 1022 patients are required to test the superiority hypothesis with 80% power according to a two-side 0.05 level of significance, stratified by age, gender, history of stroke or transient ischemic attack, history of hypertension, history of diabetes mellitus, systolic blood pressure at admission, time from IVT to treatment, thrombolysis drug, stroke territory, and stroke etiology.
Early antiplatelet for minor stroke following thrombolysis is a prospective, double-blinded, multicenter, randomized and placebo-controlled trial. Minor stroke patients within 6 h following IVT are randomly assigned into experimental group and control group with the ratio of 1:1. The experimental group is orally administered with 300 mg clopidogrel and 100 mg aspirin, and control group with placebo. Subsequently, both groups received guideline-based antithrombotic treatment from 24 h after IVT to 90 days.
The primary efficacy endpoint is excellent functional outcome, defined as the modified Rankin Scale 0-1 at 90 days after randomization, while primary safety endpoint is symptomatic intracerebral hemorrhage, defined as National Institutes of Health Stroke Scale score increase ⩾ 4 caused by intracranial hemorrhage within 36 h after randomization.
The results of EAST will provide us powerful early antiplatelet evidence for minor stroke population following intravenous thrombolysis in clinical practice.
约 10%接受静脉溶栓（IVT）的患者会出现早期神经功能恶化（END），且与预后不良相关。理论上，IVT 后早期抗血小板治疗可通过预防再闭塞和卒中进展来减少 END，但目前的指南建议在 IVT 后 24 小时开始抗血小板治疗，因为担心出血转化。鉴于严重卒中患者出血转化风险较高，我们假设 IVT 后轻度卒中患者可安全地从早期抗血小板治疗中获益。
探索 IVT 后轻度卒中患者早期抗血小板治疗的疗效和安全性。
根据双侧 0.05 水平的显著性和 80%的效能，最多需要 1022 例患者来检验优势假设，按年龄、性别、卒中或短暂性脑缺血发作史、高血压史、糖尿病史、入院时收缩压、IVT 至治疗时间、溶栓药物、卒中部位和卒中病因进行分层。
早期抗血小板治疗轻度卒中溶栓后是一项前瞻性、双盲、多中心、随机、安慰剂对照试验。IVT 后 6 小时内的轻度卒中患者被随机分为实验组和对照组，比例为 1:1。实验组给予氯吡格雷 300mg 和阿司匹林 100mg 口服，对照组给予安慰剂。随后，两组均在 IVT 后 24 小时至 90 天接受基于指南的抗血栓治疗。
主要疗效终点为 90 天改良 Rankin 量表评分 0-1，主要安全性终点为随机分组后 36 小时内由颅内出血引起的 NIHSS 评分增加⩾4 的症状性颅内出血。
EAST 的结果将为 IVT 后轻度卒中患者的临床实践中提供强有力的早期抗血小板治疗证据。
