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Updated: Jun 5, 2025
Optimized Management of Endovascular Treatment for Acute Ischemic Stroke
Published on: January 18, 2018
Extending the time window for tenecteplase by effective reperfusion of penumbral tissue in patients with large vessel
Vignan Yogendrakumar1,2,3, Bruce Cv Campbell1,2, Leonid Churilov2
1Department of Neurology, Melbourne Brain Centre, The Royal Melbourne Hospital, The University of Melbourne, Parkville, VIC, Australia.
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, blinded-endpoint, 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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