Evidence map›Paper›PMID 35590386›Full record

Trial reportTrials2022

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 and 7 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03181360 (Tenecteplase in Wake-up Ischaemic Stroke Trial), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03181360 phase3unknown statusnot on this map

Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST). A Randomised-controlled Trial of Thrombolytic Treatment With Tenecteplase for Acute Ischaemic Stroke Upon Awakening

TypeinterventionalSponsorUniversity Hospital of North NorwayRan2017 to 2022Enrolled600ConditionsIschemic Stroke, Stroke, AcuteArmsTenecteplase, Control
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 13 institutions in 8 countries.

Agnethe EltoftDepartment of Neurology, University Hospital of North Norway, Tromsø, Norway. agnethe.eltoft@unn.no.ORCID http://orcid.org/0000-0001-9808-879X
Tom WilsgaardDepartment of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.
Melinda B RoaldsenDepartment of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, Norway.
Mary-Helen SøylandDepartment of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, Norway.
Erik LundströmDepartment of Neuroscience, Neurology, Uppsala University, Uppsala, Sweden.
Jesper PeterssonDepartment of Neurology, Skåne University Hospital, Malmö, Sweden.
Bent IndredavikDepartment of Medicine, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
Jukka PutaalaDepartment of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Hanne ChristensenDepartment of Neurology, Bispebjerg Hospital and University of Copenhagen, Copenhagen, Denmark.
Janika KõrvDepartment of Neurology and Neurosurgery, University of Tartu and Tartu University Hospital, Tartu, Estonia.
Dalius JatužisDepartment of Neurology and Neurosurgery, Center for Neurology, Vilnius University, Vilnius, Lithuania.
Stefan T EngelterDepartment of Neurology, University Hospital of Basel and University of Basel, Basel, Switzerland.
Gian Marco De MarchisDepartment of Neurology, University Hospital of Basel and University of Basel, Basel, Switzerland.
David J WerringStroke Research Centre, UCL Queen Square Institute of Neurology, London, UK.
Thompson RobinsonCollege of Life Sciences and NIHR Biomedical Research Centre, University of Leicester, Leicester, UK.
Arnstein TveitenDepartment of Neurology, Sorlandet Hospital Kristiansand, Kristiansand, Norway.
Ellisiv B MathiesenDepartment of Neurology, University Hospital of North Norway, Tromsø, Norway.ORCID http://orcid.org/0000-0001-8887-6100
University Hospital of North Norway · NOSørlandet Sykehus · NOUniversity of Basel · CHNational Hospital for Neurology and Neurosurgery · GBNorwegian University of Science and Technology · NOSkåne University Hospital · SETartu University Hospital · EEUiT The Arctic University of Norway · NOUniversity of Copenhagen · DKUniversity of Helsinki · FIUniversity of Leicester · GBUppsala University · SEVilnius University · LT

Funding

British Heart Foundation CS/17/5/32826
6 · The paper itself

Abstract

backgroundPatients 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.

objectiveTo publish the detailed statistical analysis plan for TWIST prior to unblinding.

methodsThe 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 registrationClinicalTrials.gov NCT03181360 . EudraCT Number 2014-000096-80 . WHO ICRTP registry number ISRCTN10601890 .

Indexed as

Brain IschemiaIschemic StrokeStrokeFibrinolytic AgentsHumansTenecteplaseThrombolytic TherapyTissue Plasminogen ActivatorTreatment OutcomeFibrinolytic AgentsTenecteplaseTissue Plasminogen ActivatorAcute stroke therapyIschemic strokeTenecteplaseThrombolysisTWISTWake-up stroke

Identifiers

PMID35590386
PMCPMC9118782
OpenAlexW4280588953

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.