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

Trials. 2022 May 19;23(1):421. doi: 10.1186/s13063-022-06301-0.


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: NCT03181360 . EudraCT Number 2014-000096-80 . WHO ICRTP registry number ISRCTN10601890 .

Keywords: Acute stroke therapy; Ischemic stroke; TWIST; Tenecteplase; Thrombolysis; Wake-up stroke.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Brain Ischemia* / diagnostic imaging
  • Brain Ischemia* / drug therapy
  • Fibrinolytic Agents / adverse effects
  • Humans
  • Ischemic Stroke*
  • Stroke* / diagnostic imaging
  • Stroke* / drug therapy
  • Tenecteplase / adverse effects
  • Thrombolytic Therapy
  • Tissue Plasminogen Activator / adverse effects
  • Treatment Outcome


  • Fibrinolytic Agents
  • Tissue Plasminogen Activator
  • Tenecteplase

Associated data