Rationale and design of Treatment of Acute Ischaemic Stroke with Edaravone Dexborneol II (TASTE-2): a multicentre randomised controlled trial

作者：Chunjuan Wang, Hongqiu Gu, Qiang Dong, Anding Xu, Ning Wang, Yi Yang, Feng Wang, Yongjun Wang · 发表于：Stroke and Vascular Neurology · 年份：2024 · DOI：10.1136/svn-2023-002938 · 被引用次数：14 · 研究领域：Acute Ischemic Stroke Management、Neuroinflammation and Neurodegeneration Mechanisms、Intracerebral and Subarachnoid Hemorrhage Research

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 achievi...