Department of Neurological Intervention, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
BMJ Open. 2021 May 25;11(5):e045559. doi: 10.1136/bmjopen-2020-045559.
As a neuroprotective medication, butylphthalide (NBP) may help protect against cerebral ischaemic injury. However, evidence on whether NBP influences the outcomes of patients who had acute ischaemic stroke who are receiving revascularisation treatment is limited. This study aims to evaluate whether additional NBP therapy can improve the functional outcome of patients who receive intravenous recombinant tissue plasminogen activator and/or endovascular treatment (EVT).
The study will be a randomised, double-blind, placebo-controlled, multiple-centre, parallel group trial. The sample size is estimated at 1200 patients. Eligible patients will be randomised at a 1:1 ratio to receive either NBP or placebo daily for 90 days, which will include 14 days of injections and 76 days of capsules. The first use of NBP/placebo will be started within 6 hours of onset of ischaemic stroke. The primary outcome is the functional outcome as assessed by the 90-day modified Rankin Scale, adjusted for baseline scores on the National Institutes of Health Stroke Scale. The primary safety outcome is the percentage of serious adverse events during the 90 days of treatment. This trial will determine whether NBP medication benefits patients who had acute ischaemic stroke who receive intravenous thrombolysis or EVT.
The protocol was written according to the general ethical guidelines of the Declaration of Helsinki and approved by the Institutional Review Board/Ethics Committee of Beijing Tiantan Hospital, Capital Medical University with approval number KY 2018-003-02. Ethics committees of all participating sites have approved the study . Results of the study will be published in peer-reviewed scientific journals and shared in scientific presentations.
NCT03539445.
丁基苯酞（NBP）作为一种神经保护药物，可能有助于预防脑缺血损伤。然而，关于 NBP 是否会影响接受血管再通治疗的急性缺血性脑卒中患者结局的证据有限。本研究旨在评估额外的 NBP 治疗是否能改善接受静脉重组组织型纤溶酶原激活剂和/或血管内治疗（EVT）的患者的功能结局。
该研究将是一项随机、双盲、安慰剂对照、多中心、平行组试验。样本量估计为 1200 例患者。符合条件的患者将以 1:1 的比例随机分为 NBP 组或安慰剂组，每天接受治疗 90 天，其中包括 14 天的注射和 76 天的胶囊。NBP/安慰剂的首次使用将在缺血性脑卒中发病后 6 小时内开始。主要结局是 90 天改良 Rankin 量表评估的功能结局，调整基线国立卫生研究院卒中量表评分。主要安全性结局是治疗 90 天内严重不良事件的百分比。本试验将确定 NBP 药物是否使接受静脉溶栓或 EVT 的急性缺血性脑卒中患者获益。
方案根据《赫尔辛基宣言》的一般伦理准则编写，并得到首都医科大学附属北京天坛医院机构审查委员会/伦理委员会的批准，批准号为 KY 2018-003-02。所有参与地点的伦理委员会均批准了该研究。研究结果将发表在同行评议的科学期刊上，并在科学报告中分享。
NCT03539445。
