急性缺血性脑血管事件中的替奈普酶再灌注疗法 III (TRACE III) 的原理和设计:一项随机、III 期、开放标签对照试验。

IF 4.4 1区 医学 Q1 CLINICAL NEUROLOGY Stroke and Vascular Neurology Pub Date : 2024-02-27 DOI:10.1136/svn-2023-002310
Yunyun Xiong, Bruce C V Campbell, Marc Fisher, Lee H Schwamm, Mark Parsons, Hao Li, Yuesong Pan, Xia Meng, Xingquan Zhao, Yongjun Wang
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引用次数: 0

摘要

背景和目的:重组人TNK组织型纤溶酶原激活剂(rhTNK-tPA)治疗4.5小时内缺血性脑卒中的疗效并不比阿替普酶差。我们的研究旨在探讨 rhTNK-tPA 对前循环大血管闭塞(LVO)导致的缺血性中风患者超过 4.5 小时的疗效和安全性:急性缺血性脑血管事件中的替尼肽酶再灌注疗法-III(TRACE III)是一项多中心、前瞻性、随机、开放标签、盲终点、对照临床试验。研究对象为自最后一次已知脑卒中(包括唤醒脑卒中和无目击脑卒中)起 4.5-24 小时内因前循环 LVO(颈内动脉、大脑中动脉 M1 和 M2 段)导致缺血性脑卒中且组织(缺血核心容积)可挽救的患者:主要疗效指标为 90 天时改良 Rankin 量表(mRS)评分≤1。次要疗效指标包括:90 天时的 mRS 排序分布、72 小时时与初始缺损相比下降≥8 分或美国国立卫生研究院卒中量表(NIHSS)评分≤1 分所定义的主要神经功能改善、90 天时的 mRS 评分≤2 分、24 小时时 Tmax >6 秒的改善率以及 7 天时 NIHSS 评分与基线相比的变化。安全性结果为36小时内无症状性脑内出血和90天时的死亡率:讨论:TRACE III将为rhTNK-tPA治疗因前循环LVO导致缺血性脑卒中超过4.5小时的患者的有效性和安全性提供证据:试验注册号:NCT05141305。
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Rationale and design of Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events III (TRACE III): a randomised, phase III, open-label, controlled trial.

Background and purpose: Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) was not inferior to alteplase for ischaemic stroke within 4.5 hours. Our study aimed to investigate the efficacy and safety of rhTNK-tPA in patients who had an ischaemic stroke due to large vessel occlusion (LVO) of anterior circulation beyond 4.5 hours.

Methods and design: Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-III (TRACE III) is a multicentre, prospective, randomised, open-label, blind endpoint, controlled clinical trial. Patients who had an ischaemic stroke due to anterior circulation LVO (internal carotid artery, middle cerebral artery M1 and M2 segments) within 4.5-24 hours from last known well (including wake-up stroke and no witness stroke) and with salvageable tissue (ischaemic core volume <70 mL, mismatch ratio ≥1.8 and mismatch volume ≥15 mL) based on CT perfusion or MRI perfusion-weighted imaging (PWI) were included and randomised to rhTNK-tPA 0.25 mg/kg (single bolus) to a maximum of 25 mg or standard medical therapy. Specially, we will exclude patients who are intended for direct thrombectomy. All will be followed up for 90 days.

Study outcomes: Primary efficacy outcome is modified Rankin Scale (mRS) score ≤1 at 90 days. Secondary efficacy outcomes include ordinal distribution of mRS at 90 days, major neurological improvement defined by a decrease ≥8 points compared with the initial deficit or a score ≤1 on the National Institutes of Health Stroke Scale (NIHSS) at 72 hours, mRS score ≤2 at 90 days, the rate of improvement on Tmax >6 s at 24 hours and NIHSS score change from baseline at 7 days. Safety outcomes are symptomatic intracerebral haemorrhage within 36 hours and mortality at 90 days.

Discussion: TRACE III will provide evidence for the efficacy and safety of rhTNK-tPA in patients who had an ischaemic strokes due to anterior circulation LVO beyond 4.5 hours.

Trial registration number: NCT05141305.

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来源期刊
Stroke and Vascular Neurology
Stroke and Vascular Neurology Medicine-Cardiology and Cardiovascular Medicine
CiteScore
11.20
自引率
1.70%
发文量
63
审稿时长
15 weeks
期刊介绍: Stroke and Vascular Neurology (SVN) is the official journal of the Chinese Stroke Association. Supported by a team of renowned Editors, and fully Open Access, the journal encourages debate on controversial techniques, issues on health policy and social medicine.
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