TY - JOUR
T1 - Tenecteplase in wake-up ischemic stroke trial
T2 - Protocol for a randomized-controlled trial
AU - Roaldsen, Melinda B
AU - Lindekleiv, Haakon
AU - Eltoft, Agnethe
AU - Jusufovic, Mirza
AU - Søyland, Mary-Helen
AU - Petersson, Jesper
AU - Indredavik, Bent
AU - Tveiten, Arnstein
AU - Putaala, Jukka
AU - Christensen, Hanne
AU - Kõrv, Janika
AU - Jatužis, Dalius
AU - Engelter, Stefan T
AU - Marco De Marchis, Gian
AU - Wilsgaard, Tom
AU - Werring, David J
AU - Robinson, Thompson
AU - Mathiesen, Ellisiv B
AU - Berge, Eivind
PY - 2021/10
Y1 - 2021/10
N2 - 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.
AB - 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.
KW - Brain Ischemia/drug therapy
KW - Fibrinolytic Agents/therapeutic use
KW - Humans
KW - Ischemic Stroke/drug therapy
KW - Prospective Studies
KW - Randomized Controlled Trials as Topic
KW - Tenecteplase/therapeutic use
KW - Tissue Plasminogen Activator/therapeutic use
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85100170815&partnerID=8YFLogxK
U2 - 10.1177/1747493020984073
DO - 10.1177/1747493020984073
M3 - Journal article
C2 - 33446083
SN - 1747-4930
VL - 16
SP - 990
EP - 994
JO - International journal of stroke : official journal of the International Stroke Society
JF - International journal of stroke : official journal of the International Stroke Society
IS - 8
ER -