NCT03181360: TWIST

Tenecteplase in Wake-up Ischaemic Stroke Trial

Status unknown Phase 3 Last updated 14 May 2021

What this trial tests

Phase 3 trial testing Tenecteplase in Ischemic Stroke in 600 participants. Status unknown.

Timeline

12 June 2017

Primary endpoint
31 December 2021

31 December 2022

Quick facts

Lead sponsor	University Hospital of North Norway
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	600
Start date	12 June 2017
Primary completion	31 December 2021
Estimated completion	31 December 2022
Sites	83 locations across Denmark, New Zealand, Finland, Sweden, Estonia, United Kingdom, Norway, Lithuania

Drugs / interventions tested

• Tenecteplase (TENECTEPLASE) — full drug profile →
• Control

Conditions studied

• Ischemic Stroke — all drugs for Ischemic Stroke →
• Stroke, Acute — all drugs for Stroke, Acute →

Sponsor

University Hospital of North Norway

Who can join

18 and older, any sex, with Ischemic Stroke or Stroke, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Stroke is a leading causes of death and disability. At least 20% of strokes occur during sleep, so- called 'wake up stroke'. Thrombolysis with the clot-busting drug alteplase is effective for acute ischaemic stroke, provided that it is given within 4.5 hours of symptom onset. Patients with wake-up stroke are currently ineligible for clot-busting therapy. Previous studies indicate that many wake-up strokes occur just before awakening.

In this study, patients with wake-up stroke will be randomized to thrombolysis with tenecteplase and best standard treatment or to best standard treatment without thrombolysis. Tenecteplase has several potential advantages over alteplase, including very rapid action and that it can be given as a single injection. Prior to thrombolysis, a brain scan must be done to exclude bleeding or significant brain damage as a result from the stroke. We will use a CT scan to inform this decision. CT is used as a routine examination in all stroke patients. Other studies testing clot-busting treatment in wake-up stroke are using alteplase and more complex brain scans, which are not routinely available in the emergency situation in all hospitals.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. European Stroke Organisation (ESO) guidelines on intravenous thrombolysis for acute ischaemic stroke.
   Berge E, Whiteley W, Audebert H, De Marchis GM, et al · · 2021 · cited 816× · PMID 33817340 · DOI 10.1177/2396987321989865
2. Tenecteplase Thrombolysis for Acute Ischemic Stroke.
   Warach SJ, Dula AN, Milling TJ. · · 2020 · cited 150× · PMID 33045929 · DOI 10.1161/strokeaha.120.029749
3. Safety and efficacy of tenecteplase versus alteplase in patients with acute ischaemic stroke (TRACE): a multicentre, randomised, open label, blinded-endpoint (PROBE) controlled phase II study.
   Li S, Pan Y, Wang Z, Liang Z, et al · · 2022 · cited 78× · PMID 34429364 · DOI 10.1136/svn-2021-000978
4. Safety and efficacy of tenecteplase in patients with wake-up stroke assessed by non-contrast CT (TWIST): a multicentre, open-label, randomised controlled trial.
   Roaldsen MB, Eltoft A, Wilsgaard T, Christensen H, et al · · 2023 · cited 77× · PMID 36549308 · DOI 10.1016/s1474-4422(22)00484-7
5. European Stroke Organisation - European Society for Minimally Invasive Neurological Therapy expedited recommendation on indication for intravenous thrombolysis before mechanical thrombectomy in patients with acute ischaemic stroke and anterior circulation large vessel occlusion.
   Turc G, Tsivgoulis G, Audebert HJ, Boogaarts H, et al · · 2022 · cited 75× · PMID 35300256 · DOI 10.1177/23969873221076968
6. Intravenous thrombolytic treatment and endovascular thrombectomy for ischaemic wake-up stroke.
   Roaldsen MB, Lindekleiv H, Mathiesen EB. · · 2021 · cited 19× · PMID 34850380 · DOI 10.1002/14651858.cd010995.pub3
7. Tenecteplase in wake-up ischemic stroke trial: Protocol for a randomized-controlled trial.
   Roaldsen MB, Lindekleiv H, Eltoft A, Jusufovic M, et al · · 2021 · cited 17× · PMID 33446083 · DOI 10.1177/1747493020984073
8. Tenecteplase in Ischemic Stroke: Challenge and Opportunity.
   Li G, Wang C, Wang S, Xiong Y, et al · · 2022 · cited 12× · PMID 35586365 · DOI 10.2147/ndt.s360967