Background Edaravone dexborneol is believed to be a novel cytoprotective drug, demonstrating a synergistic combination of antioxidative and anti-inflammatory properties in animal models. The Treatment of Acute Ischaemic Stroke with Edaravone Dexborneol (TASTE) trial demonstrated its superior efficacy over edaravone alone for acute ischaemic stroke (AIS) patients. However, its efficacy in individuals undergoing endovascular therapy (EVT) remains uncertain. Aim To clarify the rationale and design of the TASTE II (TASTE-2) trial. Design The TASTE-2 is a multicentre, double-blind, randomised, placebo-controlled trial designed to evaluate the efficacy and safety of edaravone dexborneol in patients with AIS and large-vessel occlusion in the anterior circulation. The eligible participants, presenting with a National Institute of Health Stroke Scale score between 6 and 25 (range 0–42, with larger values suggesting severe neurological dysfunction) and an Alberta Stroke Program Early Computed Tomography Score ranging from 6 to 10 (range 0–10, with smaller values suggesting larger infarction) within the initial 24 hours after symptom onset, will be randomly allocated to either the edaravone dexborneol group or the placebo group in equal proportions prior to thrombectomy. The treatment will be continuously administered for a duration of 10–14 days. A follow-up period of 90 days will be implemented for all participants. Study outcomes The primary efficacy outcome is defined as achieving favourable functional independence, measured by a modified Rankin Scale of 0–2 at 90 days. The primary safety outcome focuses on the incidence of serious adverse events. Discussion The TASTE-2 trial will provide evidence to determine whether the administration of edaravone dexborneol in AIS patients undergoing EVT could yield significant improvements in neurological function. Data are available on reasonable request.

中文翻译：

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用依达拉奉右冰片 II 治疗急性缺血性中风 (TASTE-2) 的基本原理和设计：一项多中心随机对照试验

背景 依达拉奉右冰片被认为是一种新型细胞保护药物，在动物模型中证明了抗氧化和抗炎特性的协同组合。用依达拉奉右冰片治疗急性缺血性中风 (TASTE) 试验表明，对于急性缺血性中风 (AIS) 患者，其疗效优于单独使用依达拉奉。然而，其对接受血管内治疗（EVT）的个体的疗效仍不确定。目的 阐明 TASTE II (TASTE-2) 试验的基本原理和设计。设计 TASTE-2 是一项多中心、双盲、随机、安慰剂对照试验，旨在评估依达拉奉右冰片对 AIS 和前循环大血管闭塞患者的疗效和安全性。符合资格的参与者，美国国立卫生研究院卒中量表评分为 6 至 25 分（范围为 0-42，数值较大表明严重神经功能障碍），艾伯塔省卒中计划早期计算机断层扫描评分为 6 至 10 分（范围为 0-42）。症状出现后最初 24 小时内（数值越小表明梗死面积越小），在血栓切除术之前将按相同比例随机分配到依达拉奉右冰片组或安慰剂组。治疗将持续进行 10-14 天。将对所有参与者实施 90 天的随访期。研究结果 主要疗效结果定义为实现良好的功能独立性，通过 90 天时的改良 Rankin 量表 0-2 进行测量。主要安全结果侧重于严重不良事件的发生率。讨论 TASTE-2 试验将提供证据来确定接受 EVT 的 AIS 患者服用依达拉奉右冰片是否可以显着改善神经功能。可根据合理要求提供数据。