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Tenecteplase in wake-up ischemic stroke trial: Protocol for a randomized-controlled trial

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journal contribution
posted on 09.09.2021, 10:20 by Melinda B Roaldsen, Haakon Lindekleiv, Agnethe Eltoft, Mirza Jusufovic, Mary-Helen Soyland, Jesper Petersson, Bent Indredavik, Arnstein Tveiten, Jukka Putaala, Hanne Christensen, Janika Korv, Dalius Jatuzis, Stefan T Engelter, Gian Marco De Marchis, Tom Wilsgaard, David J Werring, Thompson Robinson, Ellisiv B Mathiesen, Eivind Berge
Background: Patients with wake-up ischemic stroke who have evidence of salvageable tissue on advanced imaging can benefit from intravenous thrombolysis. It is not known whether patients who do not fulfil such imaging criteria might benefit from treatment, but studies indicate that treatment based on non-contrast CT criteria may be safe. Tenecteplase has shown promising results in patients with acute ischemic stroke. The aim of the Tenecteplase in Wake-up Ischemic Stroke Trial (TWIST) is to compare the effect of thrombolytic treatment with tenecteplase and standard care versus standard care alone in patients with wake-up ischemic stroke selected by non-contrast CT. Methods/design: TWIST is an international, investigator-initiated, multi-centre, prospective, randomized-controlled, open-label, blinded end-point trial of tenecteplase (n = 300) versus standard care (n = 300) in patients who wake up with an acute ischemic stroke and can be treated within 4.5 h upon awakening. Seventy-seven centres in 10 countries (Denmark, Estonia, Finland, Latvia, Lithuania, New Zealand, Norway, Sweden, Switzerland, and the United Kingdom) participate. The primary outcome is the modified Rankin Scale on the ordinal scale (0–6) at three months. Discussion: TWIST aims to determine the effect and safety of thrombolytic treatment with tenecteplase in patients with wake-up ischemic stroke selected by non-contrast CT. Trial registration: ClinicalTrials.gov NCT03181360. EudraCT Number 2014-000096-80.

History

Author affiliation

Department of Cardiovascular Sciences, University of Leicester

Version

VoR (Version of Record)

Published in

International Journal of Stroke

Publisher

SAGE Publications

issn

1747-4930

eissn

1747-4949

Acceptance date

19/11/2020

Copyright date

2020

Available date

09/09/2021

Notes

Corregendum Roaldsen MB, Lindekleiv H, Eltoft A et al. Tenecteplase in wake-up ischemic stroke trial: Protocol for a randomized-controlled trial. Int J Stroke. Epub ahead of print 14 January 2021. DOI: 10.1177/1747493020984073. In this article, Professor Eivind Berge’s name was incorrectly listed as “Eivind Bergenr” in the initial OnlineFirst version. The online and print versions have been updated to reflect the correct name, “Eivind Berge.”

Spatial coverage

United States

Language

English