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

Publication

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

Journal Paper/Review - May 19, 2022

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

Citation

Eltoft A, Wilsgaard T, Roaldsen M, Søyland M, Lundström E, Petersson J, Indredavik B, Putaala J, Christensen H, Kõrv J, Jatužis D, Engelter S, De Marchis G, Werring D, Robinson T, Tveiten A, Mathiesen E. Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST). Trials 2022; 23:421.

Type

Journal Paper/Review (English)

Journal

Trials 2022; 23

Publication Date

May 19, 2022

Issn Electronic

1745-6215

Pages

421

Brief description/objective

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.