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Tenecteplase in wake-up ischemic stroke trial : Protocol for a randomized-controlled trial

Roaldsen, Melinda B. ; Lindekleiv, Haakon ; Eltoft, Agnethe ; Jusufovic, Mirza ; Søyland, Mary Helen ; Petersson, Jesper LU ; Indredavik, Bent ; Tveiten, Arnstein ; Putaala, Jukka and Christensen, Hanne , et al. (2021) In International Journal of Stroke 16(8). p.990-994
Abstract

Background: Patients with wake-up ischemic stroke who have evidence of salvageable tissue on advanced imaging can benefit from intravenous thrombolysis. It is not known whether patients who do not fulfil such imaging criteria might benefit from treatment, but studies indicate that treatment based on non-contrast CT criteria may be safe. Tenecteplase has shown promising results in patients with acute ischemic stroke. The aim of the Tenecteplase in Wake-up Ischemic Stroke Trial (TWIST) is to compare the effect of thrombolytic treatment with tenecteplase and standard care versus standard care alone in patients with wake-up ischemic stroke selected by non-contrast CT. Methods/design: TWIST is an international, investigator-initiated,... (More)

Background: Patients with wake-up ischemic stroke who have evidence of salvageable tissue on advanced imaging can benefit from intravenous thrombolysis. It is not known whether patients who do not fulfil such imaging criteria might benefit from treatment, but studies indicate that treatment based on non-contrast CT criteria may be safe. Tenecteplase has shown promising results in patients with acute ischemic stroke. The aim of the Tenecteplase in Wake-up Ischemic Stroke Trial (TWIST) is to compare the effect of thrombolytic treatment with tenecteplase and standard care versus standard care alone in patients with wake-up ischemic stroke selected by non-contrast CT. Methods/design: TWIST is an international, investigator-initiated, multi-centre, prospective, randomized-controlled, open-label, blinded end-point trial of tenecteplase (n = 300) versus standard care (n = 300) in patients who wake up with an acute ischemic stroke and can be treated within 4.5 h upon awakening. Seventy-seven centres in 10 countries (Denmark, Estonia, Finland, Latvia, Lithuania, New Zealand, Norway, Sweden, Switzerland, and the United Kingdom) participate. The primary outcome is the modified Rankin Scale on the ordinal scale (0–6) at three months. Discussion: TWIST aims to determine the effect and safety of thrombolytic treatment with tenecteplase in patients with wake-up ischemic stroke selected by non-contrast CT. Trial registration: ClinicalTrials.gov NCT03181360. EudraCT Number 2014-000096-80.

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publishing date
type
Contribution to journal
publication status
published
subject
keywords
acute ischemic stroke, intravenous thrombolysis, Tenecteplase, TWIST, wake-up stroke
in
International Journal of Stroke
volume
16
issue
8
pages
990 - 994
publisher
Wiley-Blackwell
external identifiers
  • scopus:85100170815
  • pmid:33446083
ISSN
1747-4930
DOI
10.1177/1747493020984073
language
English
LU publication?
no
id
17c3b997-9df2-4897-a119-fefee691556a
date added to LUP
2021-02-15 12:40:22
date last changed
2024-06-13 06:59:05
@article{17c3b997-9df2-4897-a119-fefee691556a,
  abstract     = {{<p>Background: Patients with wake-up ischemic stroke who have evidence of salvageable tissue on advanced imaging can benefit from intravenous thrombolysis. It is not known whether patients who do not fulfil such imaging criteria might benefit from treatment, but studies indicate that treatment based on non-contrast CT criteria may be safe. Tenecteplase has shown promising results in patients with acute ischemic stroke. The aim of the Tenecteplase in Wake-up Ischemic Stroke Trial (TWIST) is to compare the effect of thrombolytic treatment with tenecteplase and standard care versus standard care alone in patients with wake-up ischemic stroke selected by non-contrast CT. Methods/design: TWIST is an international, investigator-initiated, multi-centre, prospective, randomized-controlled, open-label, blinded end-point trial of tenecteplase (n = 300) versus standard care (n = 300) in patients who wake up with an acute ischemic stroke and can be treated within 4.5 h upon awakening. Seventy-seven centres in 10 countries (Denmark, Estonia, Finland, Latvia, Lithuania, New Zealand, Norway, Sweden, Switzerland, and the United Kingdom) participate. The primary outcome is the modified Rankin Scale on the ordinal scale (0–6) at three months. Discussion: TWIST aims to determine the effect and safety of thrombolytic treatment with tenecteplase in patients with wake-up ischemic stroke selected by non-contrast CT. Trial registration: ClinicalTrials.gov NCT03181360. EudraCT Number 2014-000096-80.</p>}},
  author       = {{Roaldsen, Melinda B. and Lindekleiv, Haakon and Eltoft, Agnethe and Jusufovic, Mirza and Søyland, Mary Helen and Petersson, Jesper and Indredavik, Bent and Tveiten, Arnstein and Putaala, Jukka and Christensen, Hanne and Kõrv, Janika and Jatužis, Dalius and Engelter, Stefan T. and Marco De Marchis, Gian and Wilsgaard, Tom and Werring, David J. and Robinson, Thompson and Mathiesen, Ellisiv B. and Berge, Eivind}},
  issn         = {{1747-4930}},
  keywords     = {{acute ischemic stroke; intravenous thrombolysis; Tenecteplase; TWIST; wake-up stroke}},
  language     = {{eng}},
  month        = {{01}},
  number       = {{8}},
  pages        = {{990--994}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{International Journal of Stroke}},
  title        = {{Tenecteplase in wake-up ischemic stroke trial : Protocol for a randomized-controlled trial}},
  url          = {{http://dx.doi.org/10.1177/1747493020984073}},
  doi          = {{10.1177/1747493020984073}},
  volume       = {{16}},
  year         = {{2021}},
}