Tenecteplase Plus Butyphthalide for Stroke Within 4.5-6 Hours of Onset (EXIT-BT): a Phase 2 Study.

IF 3.8 2区 医学 Q1 CLINICAL NEUROLOGY Translational Stroke Research Pub Date : 2024-01-19 DOI:10.1007/s12975-024-01231-2
Hui-Sheng Chen, Ming-Rui Chen, Yu Cui, Xin-Yu Shen, Hong Zhang, Jiang Lu, Li-Wei Zhao, Ying-Jie Duan, Jing Li, Ya-Mei Wang, Lian-Qiu Min, Li-Hong Zhao, Li-Shu Wan, Zai-Hui Zhang, Thanh N Nguyen
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Abstract

To date, the benefit of intravenous thrombolysis is confined to within 4.5 h of onset for acute ischemic stroke (AIS) without advanced neuroimaging selection. The current trial aimed to investigate the safety and efficacy of intravenous tenecteplase (TNK) plus Dl-3-n-Butylphthalide (NBP) in AIS within 4.5 to 6 h of onset. In this randomized, multicenter trial, eligible AIS patients were randomly assigned to receive intravenous TNK (0.25 mg/kg) plus NBP or NBP within 4.5 to 6 h of onset. The primary endpoint was symptomatic intracranial hemorrhage (sICH). Secondary endpoints included excellent functional outcome defined as a modified Rankin Scale score of 0 to 1 at 90 days. 100 patients diagnosed by non-contrast CT (NCCT) were enrolled, including 50 in TNK group and 50 in control group. sICH occurred in 2.0% (1/50) in TNK group and 0.0% (0/49) in control group with no difference (unadjusted P = 0.998). The proportion of excellent functional outcome was 77.6% (38/49) in TNK group and 69.4% (34/49) in control group with non-significance (absolute difference 8.2%, P = 0.36). A significant decrease in NIHSS score at 24 h (P = 0.004) and more early neurological improvement (20.4% vs 4.1%; P = 0.026) was observed in TNK vs control group, but there was no difference in other secondary outcomes. This phase 2 study suggests that intravenous TNK with adjuvant NBP seems safe, feasible and may improve early neurological function in AIS patients within 4.5 to 6 h of symptom onset selected using NCCT.Clinical Trials Registration: This trial was registered with ClinicalTrials.gov (NCT05189509).

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特奈普酶加丁酞治疗发病 4.5-6 小时内的中风(EXIT-BT):一项 2 期研究。
迄今为止,静脉溶栓治疗仅限于急性缺血性卒中(AIS)发病后 4.5 小时内且未进行高级神经影像学选择的患者。本试验旨在研究静脉注射替奈普酶(TNK)加Dl-3-正丁基苯酞(NBP)对发病 4.5 至 6 小时内的 AIS 的安全性和有效性。在这项随机多中心试验中,符合条件的AIS患者被随机分配接受静脉注射TNK(0.25 mg/kg)加NBP或发病后4.5至6小时内接受NBP。主要终点是症状性颅内出血(sICH)。次要终点包括良好的功能预后,即 90 天后改良兰金量表评分为 0 至 1 分。经非对比 CT(NCCT)确诊的 100 例患者中,TNK 组 50 例,对照组 50 例。TNK 组发生症状性颅内出血的比例为 2.0%(1/50),对照组为 0.0%(0/49),无差异(未调整 P = 0.998)。TNK组的功能预后优良率为77.6%(38/49),对照组为69.4%(34/49),差异无学意义(绝对差异为8.2%,P=0.36)。TNK组与对照组相比,24小时后NIHSS评分明显下降(P = 0.004),早期神经功能改善更明显(20.4% vs 4.1%;P = 0.026),但其他次要结果无差异。这项2期研究表明,静脉注射TNK并辅助NBP似乎是安全、可行的,并可在使用NCCT筛选出的症状发作后4.5至6小时内改善AIS患者的早期神经功能:本试验已在 ClinicalTrials.gov (NCT05189509) 注册。
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来源期刊
Translational Stroke Research
Translational Stroke Research CLINICAL NEUROLOGY-NEUROSCIENCES
CiteScore
13.80
自引率
4.30%
发文量
130
审稿时长
6-12 weeks
期刊介绍: Translational Stroke Research covers basic, translational, and clinical studies. The Journal emphasizes novel approaches to help both to understand clinical phenomenon through basic science tools, and to translate basic science discoveries into the development of new strategies for the prevention, assessment, treatment, and enhancement of central nervous system repair after stroke and other forms of neurotrauma. Translational Stroke Research focuses on translational research and is relevant to both basic scientists and physicians, including but not restricted to neuroscientists, vascular biologists, neurologists, neuroimagers, and neurosurgeons.
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