Evidence map›Paper›PMID 37608533›Full record

ArticleJournal of stroke2023

Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5-24 Hours of Onset (ROSE-TNK): A Phase 2, Randomized, Multicenter Study.

Lu Wang, Ying-Jie Dai, Yu Cui, Hong Zhang, Chang-Hao Jiang, Ying-Jie Duan, Yong Zhao, Ye-Fang Feng, Shi-Mei Geng, Zai-Hui Zhang and 8 more

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In one paragraph

Article in Journal of stroke, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 9 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  9. Efficacy and Safety of Intravenous Thrombolytics in Ischemic Stroke Beyond the 4.5-Hour Time Window: A Systematic Review and Meta-Analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
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  14. Thrombolytic agents, more options, more challenges.Stroke and vascular neurology · 2026
    Article
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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

18 authors.

Lu WangDepartment of Neurology, General Hospital of Northern Theater Command, Shenyang, China.
Ying-Jie DaiDepartment of Neurology, General Hospital of Northern Theater Command, Shenyang, China.
Yu CuiDepartment of Neurology, General Hospital of Northern Theater Command, Shenyang, China.
Hong ZhangDepartment of Neurology, Liaoning Health Industry Group Fukuang General Hospital, Fushun, China.
Chang-Hao JiangDepartment of Neurology, Lvshunkou Traditional Chinese Medicine Hospital, Dalian, China.
Ying-Jie DuanDepartment of Neurology, Liaoning Health Industry Group Fuxinkuang General Hospital, Fuxin, China.
Yong ZhaoDepartment of Neurology, Haicheng Traditional Chinese Medicine Hospital, Haicheng, China.
Ye-Fang FengDepartment of Neurology, Huludao Second People's Hospital, Huludao, China.
Shi-Mei GengDepartment of Neurology, Beipiao Central Hospital, Beipiao, China.
Zai-Hui ZhangDepartment of Neurology, Xiuyan County Central People's Hospital, Anshan, China.
Jiang LuDepartment of Neurology, Linghai Dalinghe Hospital, Jinzhou, China.
Ping ZhangDepartment of Neurology, Fuxin Central Hospital, Fuxin, China.
Li-Wei ZhaoDepartment of Neurology, Anshan Changda Hospital, Anshan, China.
Hang ZhaoDepartment of Neurology, General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group, Benxi, China.
Yu-Tong MaDepartment of Neurology, Beipiao Central Hospital, Beipiao, China.
Cheng-Guang SongDepartment of Neurology, Benxi Central Hospital, Benxi, China.
Yi ZhangDepartment of Neurology, Tieling County Central Hospital, Tieling, China Background.
Hui-Sheng ChenDepartment of Neurology, General Hospital of Northern Theater Command, Shenyang, China.

Funding

Science and Technology Project Plan of Liao Ning Province 2019JH2/10300027
6 · The paper itself

Abstract

background and purposeIntravenous tenecteplase (TNK) efficacy has not been well demonstrated in acute ischemic stroke (AIS) beyond 4.5 hours after onset. This study aimed to determine the effect of intravenous TNK for AIS within 4.5 to 24 hours of onset.

methodsIn this pilot trial, eligible AIS patients with diffusion-weighted imaging (DWI)-fluid attenuated inversion recovery (FLAIR) mismatch were randomly allocated to intravenous TNK (0.25 mg/kg) or standard care within 4.5-24 hours of onset. The primary endpoint was excellent functional outcome at 90 days (modified Rankin Scale [mRS] score of 0-1). The primary safety endpoint was symptomatic intracranial hemorrhage (sICH).

resultsOf the randomly assigned 80 patients, the primary endpoint occurred in 52.5% (21/40) of TNK group and 50.0% (20/40) of control group, with no significant difference (unadjusted odds ratio, 1.11; 95% confidence interval 0.46-2.66; P=0.82). More early neurological improvement occurred in TNK group than in control group (11 vs. 3, P=0.03), but no significant differences were found in other secondary endpoints, such as mRS 0-2 at 90 days, shift analysis of mRS at 90 days, and change in National Institutes of Health Stroke Scale score at 24 hours and 7 days. There were no cases of sICH in this trial; however, asymptomatic intracranial hemorrhage occurred in 3 of the 40 patients (7.5%) in the TNK group.

conclusionThis phase 2, randomized, multicenter study suggests that intravenous TNK within 4.5-24 hours of onset may be safe and feasible in AIS patients with a DWI-FLAIR mismatch.

Indexed as

Acute ischemic strokeClinical trialNeuroimaging selectionTenecteplaseThrombolysis

Identifiers

PMID37608533
PMCPMC10574303

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Registered trials

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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.