■尚未研究动脉内替普酶在血管内治疗(EVT)后成功再灌注的急性基底动脉闭塞(BAO)患者中的潜在益处。
■探讨动脉内替普酶对急性BAO患者EVT后再灌注成功的疗效和安全性。
■最多需要228名患者以80%的功率根据双侧0.05的显著性水平来检验优越性假设,按中心分层。
■我们将进行前瞻性,随机化,适应性富集,开放标签,盲点,多中心试验。在EVT[改良的脑梗死溶栓(mTICI)2b-3]后成功再通的合格BAO患者将以1:1的比例随机分为实验组和对照组。实验组患者将接受动脉内替奈普酶(0.2-0.3mg/min,持续20-30分钟),而对照组患者将根据各中心的常规做法接受常规治疗。两组患者都将接受基于标准指南的药物治疗。
■主要疗效终点是有利的功能结局,定义为随机化后90天的改良Rankin量表0-3。主要安全终点是有症状的脑出血,定义为随机分组后48小时内颅内出血引起的美国国立卫生研究院卒中量表评分增加4。主要结局的亚组分析将按年龄进行,性别,基线NIHSS评分,基线pc-方面,静脉溶栓,从估计症状发作到治疗的时间,mTICI,血糖,和中风的病因。
■这项研究的结果将提供证据,证明在成功的EVT再灌注后动脉内替普酶的辅助使用是否与急性BAO患者更好的预后相关。
The potential benefit of
intraarterial tenecteplase in acute basilar artery occlusion (BAO) patients with successful reperfusion following endovascular treatment (EVT) has not been studied.
To explore the efficacy and safety of
intraarterial tenecteplase in acute BAO patients with successful reperfusion after EVT.
A maximum of 228 patients are required to test the superiority hypothesis with 80% power according to a two-side 0.05 level of significance, stratified by center.
We will conduct a prospective, randomized, adaptive-enrichment, open-label, blinded-end point, multicenter trial. Eligible BAO patients with successful recanalization after EVT [modified Thrombolysis in Cerebral Infarction (mTICI) 2b-3] will be randomly assigned into the experimental and control group with a 1:1 ratio. Patients in the experimental group will receive
intraarterial tenecteplase (0.2-0.3 mg/min for 20-30 min), while patients in the control group will receive routine treatment according to the usual practice of each center. Patients in both groups will receive standard guideline-based medical treatment.
The primary efficacy endpoint is a favorable functional outcome, defined as the modified Rankin Scale 0-3 at 90 days after randomization. The primary safety endpoint is symptomatic intracerebral hemorrhage, defined as National Institutes of Health Stroke Scale score increase ⩾4 caused by intracranial hemorrhage within 48 h after randomization. Subgroup analysis of the primary outcome will be performed by age, gender, baseline NIHSS score, baseline pc-ASPECTS, intravenous thrombolysis, time from estimated symptom onset to treatment, mTICI, blood glucose, and stroke etiology.
The results of this study will provide evidence of whether adjunct use of
intraarterial tenecteplase after successful reperfusion with EVT is associated with better outcomes for acute BAO patients.