J Stroke.  2023 Sep;25(3):371-377. 10.5853/jos.2023.00668.

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

• Wang L
• Dai YJ
• Cui Y
• Zhang H
• Jiang CH
• Duan YJ
• Zhao Y
• Feng YF
• Geng SM
• Zhang ZH
• Lu J
• Zhang P
• Zhao LW
• Zhao H
• Ma YT
• Song CG
• Zhang Y
• Chen HS

• KMID: 2546438
• DOI: http://doi.org/10.5853/jos.2023.00668

Abstract

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.

Keyword

Tenecteplase; Thrombolysis; Acute ischemic stroke; Neuroimaging selection; Clinical trial

Figure

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  Figure 1. The trial flowchart. DWI, diffusion-weighted imaging; FLAIR, fluid attenuated inversion recovery; MRI, magnetic resonance imaging.

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  Figure 2. Distribution of modified Rankin Scale scores at 90 days by treatment groups in the intention-to-treat population. TNK, tenecteplase.

Reference

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