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KMID : 1142120230250030371
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Journal of Stroke
2023 Volume.25 No. 3 p.371 ~ p.377
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Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5-24 Hours of Onset (ROSE-TNK): A Phase 2, Randomized, Multicenter Study
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Jang Dong-Cheol
Ying-Jie Dai
Yu Cui
Hong Zhang
Chang-Hao Jiang
Ying-Jie Duan
Yong Zhao
Ye-Fang Feng
Shi-Mei Geng
Zai-Hui Zhang
Jiang Lu
Ping Zhang
Li-Wei Zhao
Hang Zhao
Yu-Tong Ma
Cheng-Guang Song
Yi Zhang
Hui-Sheng Chen
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Abstract
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Background and Purpose : Intravenous 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.
Methods : In 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).
Results : Of 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.
Conclusion : This 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.
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KEYWORD
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Tenecteplase, Thrombolysis, Acute ischemic stroke, Neuroimaging selection, Clinical trial
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