Tenecteplase in wake-up ischemic stroke trial: Protocol for a randomized-controlled trial
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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.
Original language | English |
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Journal | International Journal of Stroke |
Volume | 16 |
Issue number | 8 |
Pages (from-to) | 990-994 |
ISSN | 1747-4930 |
DOIs | |
Publication status | Published - 2021 |
Bibliographical note
Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: David Werring reports grant from British Heart Foundation and personal fees from Bayer, Portola and Alnylam. Thompson Robinson reports grant from British Heart Foundation. Ellisiv B Mathiesen reports grants from the Norwegian Clinical Therapy Research in the Specialist Health Services Research Programme and from the Northern Norway Regional Health Authority. Janika K?rv reports personal fees and non-financial support from Boehringer Ingelheim and from Pfizer. Jukka Putaala reports personal fees from Boehringer-Ingelheim, Portola, Herantis Pharma and Terve Media, personal fees, and research collaboration from Medixine, Bittium, Nokia Technologies and BcB Medical, speakers honorary, advisory board, and research grant from BMS-Pfizer, Bayer and Abbott/St. Jude Medical, research collaboration, and stock ownership from Vital Signum, and grants from Business Finland and Amgen. Stefan Engelter reports advisory board compensation from Boehringer Ingelheim and Bayer, and grants from Daiichy-Sankyo.
Publisher Copyright:
© 2021 World Stroke Organization.
- acute ischemic stroke, intravenous thrombolysis, Tenecteplase, TWIST, wake-up stroke
Research areas
ID: 301818010