Wang Chunjuan, Gu Hong-Qiu, Dong Qiang, Xu Anding, Wang Ning, Yang Yi, Wang Feng, Wang Yongjun
China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Stroke Vasc Neurol. 2024 Dec 30;9(6):730-737. doi: 10.1136/svn-2023-002938.
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.
To clarify the rationale and design of the TASTE II (TASTE-2) trial.
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.
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.
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.
依达拉奉右莰醇被认为是一种新型细胞保护药物，在动物模型中显示出抗氧化和抗炎特性的协同组合。依达拉奉右莰醇治疗急性缺血性卒中（TASTE）试验表明，对于急性缺血性卒中（AIS）患者，其疗效优于单独使用依达拉奉。然而，其在接受血管内治疗（EVT）的个体中的疗效仍不确定。
阐明TASTE II（TASTE - 2）试验的基本原理和设计。
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莰醇在AIS且前循环大血管闭塞患者中的疗效和安全性。符合条件的参与者在症状发作后的最初24小时内，美国国立卫生研究院卒中量表评分在6至25分之间（范围为0 - 42分，分数越高表明神经功能障碍越严重），阿尔伯塔卒中项目早期计算机断层扫描评分在6至10分之间（范围为0 - 10分，分数越低表明梗死面积越大），将在血栓切除术之前以相等比例随机分配到依达拉奉右莰醇组或安慰剂组。治疗将持续给药10 - 14天。所有参与者将进行90天的随访。
主要疗效结果定义为在90天时通过改良Rankin量表评分为0 - 2分实现良好的功能独立性。主要安全结果关注严重不良事件的发生率。
TASTE - 2试验将提供证据，以确定在接受EVT的AIS患者中给予依达拉奉右莰醇是否能显著改善神经功能。
