Title Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST) /
Authors Eltoft, Agnethe ; Wilsgaard, Tom ; Roaldsen, Melinda B ; Soyland, Mary-Helen ; Lundstrom, Erik ; Petersson, Jesper ; Indredavik, Bent ; Putaala, Jukka ; Christensen, Hanne ; Korv, Janika ; Jatužis, Dalius ; Engelter, Stefan T ; De Marchis, Gian Marco ; Werring, David J ; Robinson, Thompson ; Tveiten, Arnstein ; Mathiesen, Ellisiv B
DOI 10.1186/s13063-022-06301-0
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Is Part of Trials.. London : BMC. 2022, vol. 23, no. 1, art. no. 421, p. 1-7.. eISSN 1745-6215
Keywords [eng] ischemic stroke ; thrombolysis ; wake-up stroke ; tenecteplase ; TWIST ; acute stroke therapy
Abstract [eng] 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 fndings. 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 (CON‑ SORT) statement and provides clear and open reporting. Discussion: Publication of the statistical analysis plan serves to reduce potential trial reporting bias and clearly out‑ lines the pre-specifed analyses. Trial registration: ClinicalTrials.gov NCT03181360. EudraCT Number 2014-000096-80. WHO ICRTP registry number ISRCTN10601890. Keywords: Ischemic.
Published London : BMC
Type Journal article
Language English
Publication date 2022
CC license CC license description