Evidence map›Paper›PMID 34429364›Full record

Trial reportStroke and vascular neurology2022

Safety and efficacy of tenecteplase versus alteplase in patients with acute ischaemic stroke (TRACE): a multicentre, randomised, open label, blinded-endpoint (PROBE) controlled phase II study.

Shuya Li, Yuesong Pan, Ziran Wang, Zhigang Liang, Huisheng Chen, Dong Wang, Yi Sui, Xingquan Zhao, Yilong Wang, WanLiang Du and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Stroke and vascular neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04676659 (Phase II Dose-finding Open Study of Recombinant Human TNK Tissue-type Plasminogen Activator), which is not on this map. Cited by 60 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 13 pooled it
9.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04676659 phase2completednot on this map

Phase II Dose-finding Open Study of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) Injection Administered Within 3 Hours After Onset of Hyperacute Ischemic Stroke

TypeinterventionalSponsorBeijing Tiantan HospitalRan2018 to 2020Enrolled240ConditionsAcute Ischemic StrokeArmsTNK-tPA
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 13 syntheses or guidelines pooled it, 100 citations in OpenAlex.

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  8. The efficacy and safety of intravenous thrombolysis with tenecteplase versus alteplase for acute ischemic stroke: a systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 1 country.

Shuya LiChina National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Beijing, China.ORCID 0000-0002-7263-0365
Yuesong PanChina National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Beijing, China.ORCID 0000-0003-3082-6789
Ziran WangDepartment of Neurology, Linyi People's Hospital, Linyi, China.
Zhigang LiangDepartment of Neurology, Affiliated Yantai Yuhuangding Hospital of Qingdao University Medical College, YanTai, China.
Huisheng ChenDepartment of Neurology, General Hospital of Northern Theatre Command, Shenyang, Liaoning, China.ORCID 0000-0002-8490-9435
Dong WangDepartment of Neurology, Baogang Hospital of Inner Monglia, Inner Monglia, China.
Yi SuiDepartment of Neurology, The First People's Hospital of Shenyang, Shenyang, China.
Xingquan ZhaoNeurology, Beijing Tiantan Hospital, Beijing, China.
Yilong WangNeurology, Beijing Tiantan Hospital, Beijing, China.
WanLiang DuDepartment of Neurology, Beijing Tiantan Hospital, Beijing, China.ORCID 0000-0002-9066-5078
Huaguang ZhengNeurology, Beijing Tiantan Hospital, Beijing, China.ORCID 0000-0001-6400-5474
Yongjun WangChina National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Beijing, China yongjunwang@ncrcnd.org.cn.
Beijing Tian Tan Hospital · CNBaogang Group (China) · CNGeneral Hospital of Shenyang Military Region · CNLinyi People's Hospital · CNNational Clinical Research Center for Digestive Diseases · CNQingdao University · CNShenyang First People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTenecteplase (TNK) possesses several pharmacological characteristics superior to conventional alteplase (rt-PA), with well-established safety and efficacy profile in Caucasians. There exists controversy over the optimal dose of intravenous rt-PA for East Asians with acute ischaemic stroke (AIS). Current study aimed to determine the safety dose range of recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) for patients with AIS in China.

methodsThis multicentre, prospective, randomised, open-label, blinded end-point, phase II study compared three tiers of 0.1, 0.25, 0.32 mg/kg rhTNK-tPA (to a maximum of 40 mg) with standard 0.9 mg/kg rt-PA (to a maximum of 90 mg) in patients who were eligible for intravenous thrombolysis. The safety outcome were symptomatic intracranial haemorrhage (sICH) within 36 hours.

resultsBetween May 2018 and February 2020, 240 patients were randomly assigned to four group, 4 of whom did not receive study treatment. The intention-to-treat analysis included 236 patients. There was no difference in the improvement on National Institutes of Health Stroke Scale at day 14 in the 3 tiers and control group (63.3%, 77.2%, 66.7% vs 62.7%). The number of sICH was 3 of 60 (5.0%) in the 0.1 mg/kg group, none in the 0.25 mg/kg group, 2 of 60 (3.3%) in the 0.32 mg/kg group and 1 (1.7%) of 59 in the rt-PA group. There were no significant between-group differences in severe adverse events.

conclusionsSimilar to the Caucasians, rhTNK-tPA was well tolerated in Chinese patients with AIS at all doses administered within 3 hours of symptom onset. The dose-efficacy profile of rhTNK-tPA needs to be established with future investigations. TRIAL REGISTRATION NUMBER: NCT04676659.

Indexed as

Brain IschemiaIschemic StrokeStrokeFibrinolytic AgentsHumansProspective StudiesTenecteplaseTissue Plasminogen ActivatorTreatment OutcomeUnited StatesFibrinolytic AgentsTenecteplaseTissue Plasminogen Activatorstrokethrombolysis

Identifiers

PMID34429364
PMCPMC8899644
OpenAlexW3194455757

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.