Alteplase versus tenecteplase for thrombolysis after ischaemic stroke (ATTEST): a phase 2, randomised, open-label, blinded endpoint study

特奈特普酶 医学 溶栓 半影 临床终点 冲程(发动机) 组织纤溶酶原激活剂 临床试验 纤溶剂 内科学 缺血 心肌梗塞 机械工程 工程类
作者
Xuya Huang,Bharath Kumar Cheripelli,Suzanne M. Lloyd,Dheeraj Kalladka,Fiona Moreton,A Siddiqui,Ian Ford,Keith W. Muir
出处
期刊:Lancet Neurology [Elsevier BV]
卷期号:14 (4): 368-376 被引量:236
标识
DOI:10.1016/s1474-4422(15)70017-7
摘要

In most countries, alteplase given within 4·5 h of onset is the only approved medical treatment for acute ischaemic stroke. The newer thrombolytic drug tenecteplase has been investigated in one randomised trial up to 3 h after stroke and in another trial up to 6 h after stroke in patients selected by advanced neuroimaging. In the Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis (ATTEST), we aimed to assess the efficacy and safety of tenecteplase versus alteplase within 4·5 h of stroke onset in a population not selected on the basis of advanced neuroimaging, and to use imaging biomarkers to inform the design of a definitive phase 3 clinical trial.In this single-centre, phase 2, prospective, randomised, open-label, blinded end-point evaluation study, adults with supratentorial ischaemic stroke eligible for intravenous thrombolysis within 4·5 h of onset were recruited from The Institute of Neurological Sciences, Glasgow, Scotland. Patients were randomly assigned (1:1) to receive tenecteplase 0·25 mg/kg (maximum 25 mg) or alteplase 0·9 mg/kg (maximum 90 mg). Treatment allocation used a mixed randomisation and minimisation algorithm including age and National Institutes of Health Stroke Scale score, generated by an independent statistician. Patients were not informed of treatment allocation; treating clinicians were aware of allocation but those assessing the primary outcome were not. Imaging comprised baseline CT, CT perfusion, and CT angiography; and CT plus CT angiography at 24-48 h. The primary endpoint was percentage of penumbra salvaged (CT perfusion-defined penumbra volume at baseline minus CT infarct volume at 24-48 h). Analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT01472926.Between Jan 1, 2012, and Sept 7, 2013, 355 patients were screened, of whom 157 were eligible for intravenous thrombolysis, and 104 patients were enrolled. 52 were assigned to the alteplase group and 52 to tenecteplase. Of 71 patients (35 assigned tenecteplase and 36 assigned alteplase) contributing to the primary endpoint, no significant differences were noted for percentage of penumbral salvaged (68% [SD 28] for the tenecteplase group vs 68% [23] for the alteplase group; mean difference 1·3% [95% CI -9·6 to 12·1]; p=0·81). Neither incidence of symptomatic intracerebral haemorrhage (by SITS-MOST definition, 1/52 [2%] tenecteplase vs 2/51 [4%] alteplase, p=0·55; by ECASS II definition, 3/52 [6%] vs 4/51 [8%], p=0·59) nor total intracerebral haemorrhage events (8/52 [15%] vs 14/51 [29%], p=0·091) differed significantly. The incidence of serious adverse events did not differ between groups (32 in the tenecteplase group, three considered probably or definitely related to drug treatment; 16 in the alteplase group, five were considered drug-related).Neurological and radiological outcomes did not differ between the tenecteplase and alteplase groups. Evaluation of tenecteplase in larger trials of patients with acute stroke seems warranted.The Stroke Association.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
SiDi发布了新的文献求助10
1秒前
3秒前
3秒前
英俊的铭应助SiDi采纳,获得10
4秒前
4秒前
小旭vip完成签到 ,获得积分10
6秒前
frl发布了新的文献求助10
7秒前
jtyuan发布了新的文献求助10
7秒前
热心市民小红花应助朝颜采纳,获得10
7秒前
FashionBoy应助朝颜采纳,获得10
8秒前
十一发布了新的文献求助10
8秒前
8秒前
qcf完成签到 ,获得积分10
8秒前
8秒前
8秒前
8秒前
万能图书馆应助SaiKeery采纳,获得10
8秒前
2024020847完成签到,获得积分10
9秒前
hob发布了新的文献求助10
11秒前
或无情完成签到 ,获得积分10
11秒前
思源应助hyc采纳,获得10
11秒前
liangye2222发布了新的文献求助10
12秒前
13秒前
小豆芽发布了新的文献求助10
13秒前
14秒前
@@@发布了新的文献求助10
14秒前
15秒前
水流众生发布了新的文献求助10
15秒前
16秒前
重要元容发布了新的文献求助10
17秒前
快乐顽童完成签到,获得积分10
17秒前
十一完成签到,获得积分20
18秒前
18秒前
hob完成签到,获得积分10
19秒前
优雅的沛春完成签到 ,获得积分10
20秒前
三金完成签到,获得积分10
20秒前
司空元正发布了新的文献求助10
20秒前
Lycerdoctor发布了新的文献求助10
20秒前
22秒前
欣欣子完成签到 ,获得积分10
23秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3988975
求助须知:如何正确求助?哪些是违规求助? 3531316
关于积分的说明 11253424
捐赠科研通 3269917
什么是DOI,文献DOI怎么找? 1804830
邀请新用户注册赠送积分活动 882063
科研通“疑难数据库(出版商)”最低求助积分说明 809068