Extending the Time Window for Tenecteplase by Effective Reperfusion in Patients with Large Vessel Occlusion
Summary
Patients presenting to the emergency department with an acute ischemic stroke due to a large vessel occlusion eligible for thrombectomy and target mismatch on computed tomography perfusion imaging within 24 hours of onset will be assessed determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomised using a central computerised allocation process to either standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg) or tenecteplase before undergoing intra-arterial clot retrieval. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.
Timeline
- Start
- 2020-08-01
- Primary completion
- 2024-07-28
- Completion
- 2025-01-06
Outcome
Missed primary endpoint
Stopped (Enrollment): “Loss of equipoise in the 0-4.5h population which comprised the majority of ETERNAL-LVO trial recruitment due to publication of other trials demonstrating efficacy of tenecteplase vs alteplase in the 0-4.5h time window.”
paper No difference in the primary outcome was observed between the tenecteplase (n=44, 37%) and standard care (n=52, 43%; adjusted risk ratio, 0.90 [95% CI, 0.66-1.21]; P=0.48). PMID 40927857 ↗
Publications
- Yogendrakumar V, Campbell BCV, Churilov L, Garcia-Esperon C, Choi PMC, Cordato DJ, Dhimal N, Olenko L, Guha P, Sharma G, Chen C, McDonald A, Thijs V, Mamun A, Dos Santos A, Balabanski AH, Kleinig TJ, Butcher KS, Devlin MJ, O'Rourke F, Donnan GA, Davis SM, Levi CR, Ma H, Parsons MW; ETERNAL-LVO Investigators. Efficacy of Tenecteplase in Large Vessel Occlusion Stroke Within 24 Hours of Symptom Onset: The ETERNAL-LVO Randomized Controlled Trial. Stroke. 2025 Dec;56(12):3332-3341. doi: 10.1161/STROKEAHA.125.052511. Epub 2025 Sep 10.
- Yogendrakumar V, Campbell BC, Churilov L, Garcia-Esperon C, Choi PM, Cordato DJ, Guha P, Sharma G, Chen C, McDonald A, Thijs V, Mamun A, Dos Santos A, Balabanski AH, Kleinig TJ, Butcher KS, Devlin MJ, O'Rourke F, Donnan GA, Davis SM, Levi CR, Ma H, Parsons MW. 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. Int J Stroke. 2025 Mar;20(3):367-372. doi: 10.1177/17474930241308660. Epub 2024 Dec 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenecteplase | Protein / enzyme biologic | 0.25 mg/kg | Intravenous |
| Comparator | Alteplase | Protein / enzyme biologic | 0.9 mg/kg | Intravenous |