Extending the time window for tenecteplase by effective reperfusion of penumbral tissue in patients with large vessel occlusion: Rationale and design of a multicenter, prospective, randomized, open-label, blinded-endpoint, controlled phase 3 trial
Date
2024
Authors
Yogendrakumar, V.
Campbell, B.C.
Churilov, L.
Garcia-Esperon, C.
Choi, P.M.C.
Cordato, D.J.
Guha, P.
Sharma, G.
Chen, C.
Mcdonald, A.
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Journal article
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International Journal of Stroke, 2024; 20(3):367-372
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Vignan Yogendrakumarhttp, Bruce CV Campbell, Leonid Churilov, Carlos Garcia-Esperon, Philip MC Choi, Dennis J Cordato, Prodipta Guha, Gagan Sharma, Chushuang Chenhttps, Amy McDonald, Vincent Thijs, Abul Mamun, Angela Dos Santos, Anna H Balabanski, Timothy J Kleinig, Ken S Butcher, Michael J Devlin, Fintan O'Rourke, Geoffrey A Donnan, Stephen M Davis, Christopher R Levi, Henry Ma, and Mark W Parsons, on Behalf of the ETERNAL-LVO Investigators
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Abstract
Rationale: The benefit of tenecteplase in the treatment of large vessel occlusion (LVO) patients presenting within 24 h of symptom onset remains unclear. Aim: This study aimed to assess the effectiveness and safety of tenecteplase, compared to standard of care, in patients presenting within the first 24 h of symptom onset with an LVO and target mismatch on perfusion computed tomography (CT). Methods and design: The “Extending the time window for Tenecteplase by Effective Reperfusion of peNumbrAL tissue in patients with Large Vessel Occlusion” (ETERNAL-LVO) trial is a prospective, randomized, open-label, blindedendpoint, phase 3, parallel-group, superiority trial with covariate-adjusted 1:1 randomization, and adaptive sample size re-estimation. Patients with an anterior circulation LVO stroke, who present within 24 h of stroke onset or last known well with a target mismatch on computed tomography perfusion (CTP) or magnetic resonance imaging (MRI), will be randomized to tenecteplase (0.25 mg/kg) or standard of care (alteplase 0.90 mg/kg or conservative management at clinician discretion) prior to undergoing endovascular therapy. Study outcomes: The primary outcome is the proportion of patients with a modified Rankin Scale (mRS) of 0–1 (no disability) or return to baseline mRS at 3 months. Secondary and safety outcomes include the proportion of patients with an mRS of 0–2 at 3 months, an ordinal analysis of the mRS at 3 months, the proportion of patients with symptomatic intracerebral hemorrhage (sICH), the proportion of patients with death due to any cause, and the proportion of patients with mRS 5–6 at 3 months (severe disability or death). Discussion: The ETERNAL-LVO trial will build on the current evidence for tenecteplase in the > 4.5-h window. Specifically, this trial will evaluate tenecteplase in a patient population who have access to endovascular therapy but may incur delays to endovascular therapy commencement or require transfer from a primary to a comprehensive stroke center. Trials registration: ClincialTrials.gov: NCT04454788.
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© 2024 World Stroke Organization. This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).