Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST)

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  • Agnethe Eltoft
  • Tom Wilsgaard
  • Melinda B. Roaldsen
  • Mary Helen Søyland
  • Erik Lundström
  • Jesper Petersson
  • Bent Indredavik
  • Jukka Putaala
  • Christensen, Hanne Krarup
  • Janika Kõrv
  • Dalius Jatužis
  • Stefan T. Engelter
  • Gian Marco De Marchis
  • David J. Werring
  • Thompson Robinson
  • Arnstein Tveiten
  • Ellisiv B. Mathiesen

Background: Patients with wake-up ischemic stroke are frequently excluded from thrombolytic treatment due to unknown symptom onset time and limited availability of advanced imaging modalities. The Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST) is a randomized controlled trial of intravenous tenecteplase 0.25 mg/kg and standard care versus standard care alone (no thrombolysis) in patients who wake up with acute ischemic stroke and can be treated within 4.5 h of wakening based on non-contrast CT findings. Objective: To publish the detailed statistical analysis plan for TWIST prior to unblinding. Methods: The TWIST statistical analysis plan is consistent with the Consolidating Standard of Reporting Trials (CONSORT) statement and provides clear and open reporting. Discussion: Publication of the statistical analysis plan serves to reduce potential trial reporting bias and clearly outlines the pre-specified analyses. Trial registration: ClinicalTrials.govNCT03181360. EudraCT Number 2014-000096-80. WHO ICRTP registry number ISRCTN10601890.

OriginalsprogEngelsk
Artikelnummer421
TidsskriftTrials
Vol/bind23
Udgave nummer1
Antal sider7
ISSN1745-6215
DOI
StatusUdgivet - 2022

Bibliografisk note

Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: DW reports grant from British Heart Foundation and personal fees from Bayer, Portola and Alnylam. TR reports grant from British Heart Foundation, and is a National Institute for Health Research (NIHR) Senior Investigator. EBM reports grants from the Norwegian Clinical Therapy Research in the Specialist Health Services Research Programme and from the Northern Norway Regional Health Authority. JK reports personal fees and non-financial support from Boehringer Ingelheim, Sevier and Pfizer. JPu reports personal fees from Boehringer Ingelheim, Portola, Herantis Pharma and Terve Media, personal fees, 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. SE reports advisory board compensation from Boehringer Ingelheim and Bayer, and grants from Daiichy-Sankyo. Open Access funding provided by UiT The Arctic University of Norway.

Publisher Copyright:
© 2022, The Author(s).

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