Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST)
dc.contributor.author | Eltoft, Agnethe | |
dc.contributor.author | Wilsgaard, Tom | |
dc.contributor.author | Roaldsen, Melinda Berg | |
dc.contributor.author | Søyland, Mary-Helen | |
dc.contributor.author | Lundström, Erik | |
dc.contributor.author | Petersson, Jesper | |
dc.contributor.author | Indredavik, Bent | |
dc.contributor.author | Putaala, Jukka | |
dc.contributor.author | Christensen, Hanne | |
dc.contributor.author | Kõrv, Janika | |
dc.contributor.author | Jatužis, Dalius | |
dc.contributor.author | Engelter, Stefan T. | |
dc.contributor.author | De Marchis, Gian Marco | |
dc.contributor.author | Werring, David J. | |
dc.contributor.author | Robinson, Thompson | |
dc.contributor.author | Tveiten, Arnstein | |
dc.contributor.author | Mathiesen, Ellisiv B. | |
dc.date.accessioned | 2022-11-10T09:24:19Z | |
dc.date.available | 2022-11-10T09:24:19Z | |
dc.date.issued | 2022-05-19 | |
dc.description.abstract | 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.<p> <p>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. <p>Discussion: Publication of the statistical analysis plan serves to reduce potential trial reporting bias and clearly out‑ lines the pre-specifed analyses. <p>Trial registration: ClinicalTrials.gov NCT03181360. EudraCT Number 2014-000096-80. WHO ICRTP registry number ISRCTN10601890. | en_US |
dc.identifier.citation | Eltoft, Wilsgaard, Roaldsen, Søyland, Lundström, Petersson, Indredavik, Putaala, Christensen, Kõrv, Jatužis, Engelter, De Marchis, Werring, Robinson, Tveiten, Mathiesen. Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST). Trials. 2022;23(1) | en_US |
dc.identifier.cristinID | FRIDAID 2045816 | |
dc.identifier.doi | 10.1186/s13063-022-06301-0 | |
dc.identifier.issn | 1745-6215 | |
dc.identifier.uri | https://hdl.handle.net/10037/27320 | |
dc.language.iso | eng | en_US |
dc.publisher | BMC | en_US |
dc.relation.journal | Trials | |
dc.rights.accessRights | openAccess | en_US |
dc.rights.holder | Copyright 2022 The Author(s) | en_US |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | en_US |
dc.rights | Attribution 4.0 International (CC BY 4.0) | en_US |
dc.title | Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST) | en_US |
dc.type.version | publishedVersion | en_US |
dc.type | Journal article | en_US |
dc.type | Tidsskriftartikkel | en_US |
dc.type | Peer reviewed | en_US |