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. 2023 Sep;25(3):371-377.
doi: 10.5853/jos.2023.00668. Epub 2023 Aug 24.

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

Lu Wang  1 , Ying-Jie Dai  1 , Yu Cui  1 , Hong Zhang  2 , Chang-Hao Jiang  3 , Ying-Jie Duan  4 , Yong Zhao  5 , Ye-Fang Feng  6 , Shi-Mei Geng  7 , Zai-Hui Zhang  8 , Jiang Lu  9 , Ping Zhang  10 , Li-Wei Zhao  11 , Hang Zhao  12 , Yu-Tong Ma  7 , Cheng-Guang Song  13 , Yi Zhang  14 , Hui-Sheng Chen  1
Affiliations

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

Lu Wang et al. J Stroke. 2023 Sep.

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.

Keywords: Acute ischemic stroke; Clinical trial; Neuroimaging selection; Tenecteplase; Thrombolysis.

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Conflict of interest statement

Conflicts of interest

The authors have no financial conflicts of interest.

Figures

Figure 1.
Figure 1.
The trial flowchart. DWI, diffusion-weighted imaging; FLAIR, fluid attenuated inversion recovery; MRI, magnetic resonance imaging.
Figure 2.
Figure 2.
Distribution of modified Rankin Scale scores at 90 days by treatment groups in the intention-to-treat population. TNK, tenecteplase.
See this image and copyright information in PMC

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