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

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

doi:10.1186/s13063-022-06301-0

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

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

Neurologisk Afd. N

3 Citationer (Scopus)

Abstract

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

Originalsprog	Engelsk
Artikelnummer	421
Tidsskrift	Trials
Vol/bind	23
Udgave nummer	1
Sider (fra-til)	421
ISSN	1745-6215
DOI	https://doi.org/10.1186/s13063-022-06301-0
Status	Udgivet - 19 maj 2022

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Eltoft, A., Wilsgaard, T., Roaldsen, M. B., Søyland, M.-H., Lundström, E., Petersson, J., Indredavik, B., Putaala, J., Christensen, H., Kõrv, J., Jatužis, D., Engelter, S. T., De Marchis, G. M., Werring, D. J., Robinson, T., Tveiten, A., & Mathiesen, E. B. (2022). Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST). Trials, 23(1), 421. Artikel 421. https://doi.org/10.1186/s13063-022-06301-0

Eltoft, A, Wilsgaard, T, Roaldsen, MB, Søyland, M-H, Lundström, E, Petersson, J, Indredavik, B, Putaala, J, Christensen, H, Kõrv, J, Jatužis, D, Engelter, ST, De Marchis, GM, Werring, DJ, Robinson, T, Tveiten, A & Mathiesen, EB 2022, 'Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST)', Trials, bind 23, nr. 1, 421, s. 421. https://doi.org/10.1186/s13063-022-06301-0

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

abstract = "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: ClinicalTrials.gov NCT03181360 . EudraCT Number 2014-000096-80 . WHO ICRTP registry number ISRCTN10601890 .",

keywords = "Brain Ischemia/diagnostic imaging, Fibrinolytic Agents/adverse effects, Humans, Ischemic Stroke, Stroke/diagnostic imaging, Tenecteplase/adverse effects, Thrombolytic Therapy, Tissue Plasminogen Activator/adverse effects, Treatment Outcome",

author = "Agnethe Eltoft and Tom Wilsgaard and Roaldsen, {Melinda B} and Mary-Helen S{\o}yland and Erik Lundstr{\"o}m and Jesper Petersson and Bent Indredavik and Jukka Putaala and Hanne Christensen and Janika K{\~o}rv and Dalius Jatu{\v z}is and Engelter, {Stefan T} and {De Marchis}, {Gian Marco} and Werring, {David J} and Thompson Robinson and Arnstein Tveiten and Mathiesen, {Ellisiv B}",

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day = "19",

doi = "10.1186/s13063-022-06301-0",

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TY - JOUR

T1 - Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST)

AU - Eltoft, Agnethe

AU - Wilsgaard, Tom

AU - Roaldsen, Melinda B

AU - Søyland, Mary-Helen

AU - Lundström, Erik

AU - Petersson, Jesper

AU - Indredavik, Bent

AU - Putaala, Jukka

AU - Christensen, Hanne

AU - Kõrv, Janika

AU - Jatužis, Dalius

AU - Engelter, Stefan T

AU - De Marchis, Gian Marco

AU - Werring, David J

AU - Robinson, Thompson

AU - Tveiten, Arnstein

AU - Mathiesen, Ellisiv B

PY - 2022/5/19

Y1 - 2022/5/19

N2 - 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: ClinicalTrials.gov NCT03181360 . EudraCT Number 2014-000096-80 . WHO ICRTP registry number ISRCTN10601890 .

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

KW - Brain Ischemia/diagnostic imaging

KW - Fibrinolytic Agents/adverse effects

KW - Humans

KW - Ischemic Stroke

KW - Stroke/diagnostic imaging

KW - Tenecteplase/adverse effects

KW - Thrombolytic Therapy

KW - Tissue Plasminogen Activator/adverse effects

KW - Treatment Outcome

UR - http://www.scopus.com/inward/record.url?scp=85130387363&partnerID=8YFLogxK

U2 - 10.1186/s13063-022-06301-0

DO - 10.1186/s13063-022-06301-0

M3 - Journal article

C2 - 35590386

SN - 1745-6215

VL - 23

SP - 421

JO - Trials

JF - Trials

IS - 1

M1 - 421

ER -

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

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