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AzTrials

Ischemic StrokePhase 3TWISTNCT03181360

Tenecteplase in Wake-up Ischaemic Stroke Trial

A Phase 3 study testing Tenecteplase in people with Ischemic Stroke and Stroke, Acute, run by University Hospital of North Norway at 83 sites in 11 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Ischemic Stroke, Stroke, Acute
What is being tested?
Tenecteplase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
83 sitesin 11 countries
Study dates
12 Jun 2017to 31 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Stroke symptoms on awakening that were not present before sleep
  • Clinical diagnosis of stroke with limb weakness with NIHSS score >=3, or dysphasia
  • Treatment with tenecteplase is possible within 4.5 hours of awakening
  • Written consent from the patient, non-written consent from the patient (witnessed by non-participating health care personnel), or written consent from the nearest family member

Who cannot join

  • Age <18 years
  • NIHSS score >25 or NIHSS consciousness score >2, or seizures during stroke onset
  • Findings on plain CT that indicate that the patient is unlikely to benefit from treatment:
  • Infarction comprising more than >1/3 of the middle cerebral artery territory on plain CT or CT perfusion
  • Intracranial haemorrhage, structural brain lesions which can mimic stroke (e.g cerebral tumour)
  • Active internal bleeding of high risk of bleeding, e.g.:
Show all 16Show fewer
  • Major surgery, trauma or gastrointestinal or urinary tract haemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days
  • Any known defect in coagulation, e.g. current use of vitamin K antagonist with an INR >1.7 or prothrombin time >15 seconds, or use of direct thrombin inhibitors or direct factor Xa inhibitors during the last 24 hours (unless reversal of effect can be achieved by agents such as idarucizumab) or with elevated sensitive laboratory tests (such as activated partial thromboplastin time (aPTT), international normalized ratio (INR), platelet count, ecarin clotting time, thrombin time (TT), or appropriate factor Xa activity assays), or heparins during the last 24 hours or with an elevated aPTT greater than the upper limit of normal
  • Known defect of clotting or platelet function or platelet count below 100,000/mm3 (but patients on antiplatelet agents can be included)
  • Ischaemic stroke or myocardial infarction in previous 3 months, previous intracranial haemorrhage, severe traumatic brain injury or intracranial or intraspinal operation in previous 3 months, or known intracranial neoplasm, arteriovenous malformation or aneurysm
  • Contraindications to tenecteplase, e.g., acute bacterial endocarditis or pericarditis; acute pancreatitis; severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension; active hepatitis; systemic cancer with increased bleeding risk; haemostatic defect including secondary to severe hepatic, renal disease; organ biopsy; prolonged cardiopulmonary resuscitation > 2 min (within 2 weeks)
  • Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg), despite blood pressure lowering treatment
  • Blood glucose <2.7 or >20.0 mmol/L (use of finger-stick measurement devices is acceptable)
  • Pregnancy, positive pregnancy test, childbirth during last 10 days, or breastfeeding. In any woman of childbearing potential, a pregnancy test must be performed and the result assessed before trial entry
  • Other serious or life-threatening disease before the stroke: severe mental or physical disability (e.g. Mini Mental Status score <20, or mRS score ≥3), or life expectancy less than 12 months
  • Patient unavailability for follow-up (e.g. no fixed address)

Trial locations and contacts

83 sites in 11 countries.

Melinda B Roaldsen, MD contact

+47 77627120

melinda.b.roaldsen@uit.no

Agnethe Eltoft, MD, PhD contact

+47 77698906

agnethe.eltoft@unn.no

83 sites in 11 countries

United Kingdom32 sites, 32 recruiting

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

    Mary Joan Macleod, MD, +44 345 456 6000, m.j.macleod@abdn.ac.uk

    Mary Joan Macleod, MD

    Not yet recruiting

  • Arrowe Park

    Birkenhead

    Ruth Davies, ruth.davies@nhs.net

    Ruth Davis, MD

    Recruiting

  • University Hospital Birmingham

    Birmingham

    Mark Willmot, mark.willmot@nhs.net

    Mark Willmot, MD

    Recruiting

  • Royal Bournemoth and Christchurch Hospital

    Bournemouth, BH7 7DW

    Oliver Hopper, MD, +441202 303626, oliver.hopper@rbch.nhs.uk

    Oliver Hopper, MD

    Not yet recruiting

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

    Elizabeth Warburton, MD, +44 1223 245151, elizabeth.warburton@addenbrookes.nhs.uk

    Elizabeth Warburton, MD

    Recruiting

  • Countess of Chester Hospital NHS Foundation Trust

    Chester, CH2 1UL

    Kausik Chatterjee, 44365000 ext. +4412, kausikchatterjee@nhs.net

    Kausik Chatterjee, MD

    Recruiting

  • University Hospitals Coventry & Warwickshire

    Coventry

    Usman Ghani, MD, usman.ghani@uhcw.nhs.uk

    Usman Ghani, MD

    Recruiting

  • Northumbria Specialist Emergency Care Hospital

    Cramlington, Northumberland

    Mark Garside, Mark.Garside@northumbria-healthcare.nhs.uk

    Mark Garside, MD

    Not yet recruiting

  • Royal Derby Hospital

    Derby, DE 22 3 NE

    Timothy England, MD, +441332340131, timothy.england@nhs.net

    Timothy England, MD

    Recruiting

  • Royal Infirmary of Edinburgh Hospital

    Edinburgh, EH16 4SA

    William Whiteley, MD, +44 131 536 1000, william.whiteley@ed.ac.uk

    William Whiteley, MD

    Not yet recruiting

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW

    Martin James, MD, +44 1392 411611, martinjames@nhs.net

    Martin James, MD

    Recruiting

  • Gloucestershire Royal Hospital

    Gloucester

    Dipankar Dutta, dipankar.dutta@glos.nhs.uk

    Dipankar Dutta, MD

    Recruiting

  • Calderdale Royal Infirmary

    Halifax

    Anand Nair, Anand.Nair@cht.nhs.uk

    Anand Nair, MD

    Recruiting

  • Hull University Teaching Hospital

    Hull

    Emma Clarkson, EmmaP.Clarkson@hey.nhs.uk

    Emma Clarkson, MD

    Recruiting

  • Leeds General Infirmary

    Leeds

    Vasileios Papavasileiou, v.papavasileiou@nhs.net

    Vasileios Papavasileiou, MD

    Recruiting

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

    Thompson G Robinson, MD, PhD, tgr2@le.ac.uk

    Lisa Manning, MD, lm313@le.ac.uk

    Recruiting

  • Royal Liverpool University Hospital

    Liverpool

    Aravind Manoj, aravind.manoj@rlbuht.nhs.uk

    Aravind Manoj, MD

    Not yet recruiting

  • University College London

    London, NW1 2BU

    Richard Perry, MD, +44 20 3456 7890, richard.perry@uclh.nhs.uk

    Richard Perry, MD

    Recruiting

  • King´s College Hospital

    London, SE5 9RS

    Lalit Kalra, MD, +44 20 3299 9000, lalit.kalra@nhs.net

    Lalit Kalra, MD

    Recruiting

  • St Georges Hospital

    London, SW17 0QT

    Barry Moynihan, MD, +44 20 8672 1255, Barry.moynihan@stgeorges.nhs.uk

    Barry Moynihan, MD

    Recruiting

  • Charing Cross Hospital

    London, W6 8RF

    Omid Halse, MD, +44 20 3311 1234, Omid.Halse@imperial.nhs.uk

    Omid Halse, MD

    Recruiting

  • Royal London Hospital

    London

    Rachel Evans, rachel.evans60@nhs.net

    Rachel Evans, MD

    Recruiting

  • Luton and Dunstable University Hospital

    Luton

    Sakthivel Sethuraman, sakthivel.sethuraman@ldh.nhs.uk

    Sakthivel Sethuraman, MD

    Recruiting

  • Morriston Hospital

    Morriston, SA6 6NL

    Mushtaq Wani, MD, +44 1792 702222, Mushtaq.Wani@wales.nhs.uk

    Mushtaq Wani, MD

    Recruiting

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

    Anand Dixit, MD, +441912336161, Anand.dixit@nuth.nhs.uk

    Anand Dixit, MD

    Recruiting

  • Nottingham City Hospital

    Nottingham, NG5 1PB

    Philip Bath, MD, +441159691169, Philip.bath@nottingham.ac.uk

    Philip Bath, MD

    Recruiting

  • Salford Royal Hospital

    Salford

    Bharath Cheripelli, bharath.cheripelli@srft.nhs.uk

    Bharath Cheripelli, MD

    Recruiting

  • Southhampton General Hospital

    Southampton

    Richard Marigold, james.marigold@uhs.nhs.uk

    Richard Marigold, MD

    Recruiting

  • Royal Stoke University Hospital

    Stoke-on-Trent

    Girish Muddegowda, girish.muddegowda2@uhnm.nhs.uk

    Girish Muddegowda, MD

    Recruiting

  • Musgrove Park Hospital

    Taunton

    Dumin Karunatilake, MD, dumin.karunatilake@tst.nhs.uk

    Dumin Karunatilake, MD

    Recruiting

  • Pinderfields Hospital

    Wakefield, Mid Yorkshire, WF1 4DG

    Michael Carpenter, MD, 48118110 ext. +4484, michael.carpenter@midyorks.nhs.net

    Michael Carpenter, MD

    Recruiting

  • Yeovil District Hospital

    Yeovil, BA21 4AT

    Khalid Rashed, MD, +44 1935 475122, khalid.rashed@ydh.nhs.uk

    Khalid Rashed, MD

    Recruiting

Other trials in United Kingdom

Norway19 sites, 15 recruiting

  • Ålesund sjukehus Helse Møre og Romsdal

    Ålesund, N-6026

    Yngve M Seljeseth, MD, +47 70105000, Yngve.Muller.Seljeseth@helse-mr.no

    Yngve M Seljeseth, MD

    Recruiting

  • Sørlandet sykehus HF Arendal

    Arendal, 4838

    Terminated

  • Drammen sykehus Vestre Viken HF

    Drammen, N-3004

    Karl-Friedrich Amthor, MD, +47 91503525, karamt@vestreviken.no

    Karl-Friedrich Amthor, MD

    Not yet recruiting

  • Sørlandet Sykehus HF Flekkefjord

    Flekkefjord, N-4400

    Rita Van Lessen, MD, +47 91503738, rita.van.lessen@sshf.no

    Rita Van Lessen, MD

    Recruiting

  • Helse Førde HF

    Førde, N-6807

    Magdalena Stankiewicz, MD, +47 57839000, magdalena.stankiewicz@helse-forde.no

    Magdalena Stankiewicz, MD

    Recruiting

  • Nordlandssykehuset Lofoten Gravdal

    Gravdal, N-8372

    Bettina Heermann, MD, +47 76060100, bettina.heermann@nordlandssykehuset.no

    Bettina Heermann, MD

    Recruiting

  • Helse Finnmark Hammerfest

    Hammerfest, N-9601

    Svein A Størdahl, MD, +47 78421000, svein.are.stordal@finnmarkssykehuset.no

    Svein A Størdahl, MD

    Recruiting

  • University Hospital of North Norway, Harstad

    Harstad, 9480

    Maria Fjellstad, MD, +47 07766, maria.serafia.fjellstad@unn.no

    Maria Fjellstad, MD

    Recruiting

  • Helse Finnmark HF Kirkenes

    Kirkenes, N-9900

    Tonje A Melum, MD, +47 78421000, tonje.anita.melum@finnmarkssykehuset.no

    Tonje A Melum, MD

    Not yet recruiting

  • Sørlandet sykehus Kristiansand HF

    Kristiansand, N-4604

    Arnstein Tveiten, MD, PhD, +47 38074000, arnstein.tveiten@sshf.no

    Mary-Helen Søyland, MD, +47 38074000, mary-helen.soyland@sshf.no

    Recruiting

  • Sykehuset Levanger

    Levanger, N-7601

    Terminated

  • Akershus universitetssykehus (Ahus)

    Lørenskog, N-1478

    Antje Reichenbach, MD, +47 91502900, antje.reichenbach@ahus.no

    Antje Reichenbach, MD

    Recruiting

  • Helgelandssykehuset Mosjøen

    Mosjøen, N-8651

    Withdrawn

  • University Hospital of North Norway, Narvik

    Narvik, N-8504

    Arne Haavik, MD, +47 76968000, arne.haavik@unn.no

    Arne Haavik, MD

    Recruiting

  • Bærum sykehus Vestre Viken HF

    Sandvika, N-1346

    Håkon Ihle-Hansen, MD, 06780 ext. +47, haaihl@vestreviken.no

    Håkon Ihle-Hansen, MD

    Recruiting

  • Sykehuset Telemark Skien

    Skien, N-3710

    Håkon Tobro, MD, +47 35003500, haa.tob@sthf.no

    Håkon Tobro, MD

    Recruiting

  • Stavanger Universitetssjukehus

    Stavanger, N-4068

    Active, not recruiting

  • University Hospital of North Norway, Tromsø

    Tromsø, N-9019

    Einar Bugge, MD, PhD, einar.bugge@unn.no

    Melinda B Roaldsen, MD, +47 77627120, melinda.b.roaldsen@uit.no

    Recruiting

  • St Olavs Hospital

    Trondheim, N-7006

    Gitta Rohweder, MD, +47 81555815, gitta.rohweder@stolav.no

    Bent Indredavik, MD, PhD, +47 81555815, bent.indredavik@ntnu.no

    Recruiting

Other trials in Norway

Sweden11 sites, 10 recruiting

  • Ängelholm Hospital

    Ängelholm, 26281

    Björn Hedström, MD, +4643181000, Bjorn.Hedstrom@skane.se

    Björn Hedström, MD

    Recruiting

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

    Jan-Erik Karlsson, MD, +46 31 342 10 00, jan-erik.karlsson@vgregion.se

    Recruiting

  • Hässleholm Sjukhus

    Hässleholm, 281 25

    Magnus Esbjörnsson, MD, +46 0451 29 60 60, Magnus.Esbjornsson@skane.se

    Recruiting

  • Central Hospital Karlstad

    Karlstad, 65230

    Felix Andler, MD, +4654615000, Felix.Andler@liv.se

    Felix Andler, MD

    Recruiting

  • Skåne University Hospital Lund

    Lund

    Gunnar Andsberg, MD

    Gunnar Andsberg, MD

    Not yet recruiting

  • Skåne University Hospital Malmö

    Malmö, 221 85

    Jesper Petersson, MD, PhD, +46 40331000, jesper.petersson@skane.se

    Recruiting

  • Skaraborg Hospital Skövde

    Skövde, 541 85

    Björn Cederin, MD, +46500431000, bjorn.cederin@vgregion.se

    Björn Cederin, MD

    Recruiting

  • Karolinska sjukhuset

    Solna, 171 76

    Withdrawn

  • Saint Göran Hospital

    Stockholm, 112 81

    Jan Mathé, MD, +46858701000, jan.mathe@capiostgoran.se

    Jan Mathé, MD

    Not yet recruiting

  • Danderyd Hospital

    Stockholm, 18288

    Elisabet Rooth, MD, +46812355000, elisabet.anggardh-rooth@sll.se

    Elisabet Rooth, MD

    Recruiting

  • Akademiska Sjukhuset

    Uppsala, 751 85

    Karl Sjölin, MD, +46 18 611 00 00, karl.sjolin@gmail.com

    Recruiting

Other trials in Sweden

Finland5 sites, 5 recruiting

  • Helsinki University Hospital

    Helsinki

    Jukka Putaala, Md, PhD, jukka.putaala@hus.fi

    Recruiting

  • Siun sote - Joint municipal authority for North Karelia social and health services

    Joensuu

    Sirpa Kaipiainen, MD

    Jussi Sipilä, MD

    Recruiting

  • Pohjois-Kymen sairaala

    Kouvola

    Tero Tapiola, +358 5 352000, tero.tapiola@kouvola.fi

    Recruiting

  • Satakunta Central Hospital

    Pori, Satakunta, 28500

    Juha Puustinen, MD, +358262771, juha.puustinen@satshp.fi

    Juha Puustinen, MD

    Recruiting

  • Central Hospital in Vaasa

    Vaasa, 65130

    Jukka Saarinen, MD, +35863231111, jukka.saarinen@vshp.fi

    Jukka Saarinen, MD

    Recruiting

Other trials in Finland

Lithuania5 sites, 5 recruiting

  • Alytus S. Kudirkos Hospital

    Alytus, 62114

    Juknelis Kestutis, MD, +37031556301, jukneliskestutis@hotmail.com

    Juknelis Kestutis, MD

    Recruiting

  • Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas, 50009

    Daiva Rastenyte, MD, +37037326467, daiva.rastenyte@kaunoklinikos.lt

    Daiva Rastenyte, MD

    Recruiting

  • Klaipeda Seamen's Hospital

    Klaipėda

    Robertas Urbutis, MD, 46 491009 ext. +370, rourb@yahoo.com

    Robertas Urbutis, MD

    Recruiting

  • Republican Vilnius University Hospital

    Vilnius, LT-04130

    Aleksandras Vilionskis, MD, aleksandras.vilionskis@gmail.com

    Recruiting

  • Vilnius University Hospital

    Vilnius, LT-08661

    Dalius Jatuzis, MD, PhD, +370 5 236 5000, dalius.jatuzis@santa.lt

    Recruiting

Other trials in Lithuania

Estonia4 sites, 4 recruiting

  • Pärnu Hospital

    Pärnu, 80010

    Katrin Antsov, MD, +3724494800, katrin.antsov@ph.ee

    Katrin Antsov, MD

    Recruiting

  • East Tallin Central Hospital

    Tallinn, 10138

    Toomas Toomsoo, MD, +3726661900, toomas.toomsoo@itk.ee

    Toomas Toomsoo, MD

    Recruiting

  • West Tallin Central Hospital

    Tallinn, 10617

    Katrin Gross-Paju, MD, +3726261314, katrin.gross-paju@keskhaigla.ee

    Katrin Gross-Paju, MD

    Recruiting

  • Tartu University Clinic

    Tartu, 51014

    Janika Kõrv, +372 731 811, janika.korv@kliinikum.ee

    Recruiting

Other trials in Estonia

Denmark2 sites, 2 recruiting

  • Bispebjerg hospital

    Copenhagen, 2400

    Hanne Christensen, MD, PhD, +45 38 63 50 00, hanne.krarup.christensen@regionh.dk

    Recruiting

  • Odense University Hospital

    Odense

    Karen Ægidius, Karen.Lehrmann.AEgidius@rsyd.dk

    Karen L. Ægidius, MD, PhD

    Recruiting

Other trials in Denmark

Switzerland2 sites, 2 recruiting

  • University Hospital Basel

    Basel, 4031

    Gian M De Marchis, MD, MSc, +41 61 265 25 25, gian.demarchis@usb.ch

    Recruiting

  • Groupement Hospitalier Ouest Lémanique

    Nyon

    Julien Niederhauser, MD, julien.niederhauser@ghol.ch

    Julien Niederhauser, MD

    Recruiting

Other trials in Switzerland

United States1 site, 1 recruiting

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

    Brian Silver, MD, 508-334-5989, Brian.Silver@umassmemorial.org

    Brian Silver, MD

    Not yet recruiting

Other trials in United States

Latvia1 site, 1 recruiting

  • Riga East University Hospital

    Riga

    Aleksejs Višņakovs

    Guntis Karelis, MD

    Not yet recruiting

Other trials in Latvia

New Zealand1 site, 1 recruiting

  • Christchurch Hospital

    Christchurch

    Teddy Wu, MD, PhD, teddy.wu@cdhb.health.nz

    Teddy Wu, MD, PhD

    Recruiting

Other trials in New Zealand

About this study

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

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.

Read the detailed description

Background:

One in five strokes occur during sleep, but patients with "wake-up" stroke are not given thrombolytic therapy because time of stroke onset is unknown. On-going trials are testing alteplase, and use MRI techniques for selection of patients. Tenecteplase has many pharmacological advantages over alteplase: greater fibrin specificity, very rapid action, longer half-life, and single bolus administration. In addition, patient selection based on MRI findings risks excluding many patients that might otherwise benefit. TWIST will test tenecteplase and will not use MRI techniques for selection of patients. Plain CT and CT angiography (if possible) will be performed before randomisation, and CT perfusion will be performed at selected centres, as part of a sub-study.

Study design: TWIST is an international, multi-centre, randomised, open-label, blinded-endpoint trial of tenecteplase for acute ischaemic 'wake-up' stroke.

Study questions:

  1. Can tenecteplase given <4.5 hours of awakening improve functional outcome at 3 months?
  2. Can findings on cerebral plain CT and CT angiography (and CT perfusion, at selected centres) identify patients who benefit from such treatment, compared to other patients?

Patients eligible for treatment who are able to receive tenecteplase within 4.5 hours of waking, will be randomly allocated to treatment with tenecteplase in addition to best standard treatment, versus best standard treatment.

Randomisation and treatment: Central randomisation (over the internet) to tenecteplase 0.25 mg/mg i.v. (maximum dose 25 mg) plus best medical treatment vs. best medical treatment alone.

Imaging: All patients will undergo CT and CT angiography (CTA, if possible) before randomisation and on day 2. CT perfusion (CTP) will be performed at selected centres, as part of a sub-study.

Follow-up and primary effect variable: Centralised follow-up via telephone or mail at 3 months. The primary effect variable is functional outcome (modified Rankin Scale score).

Study size and centers: 600 patients from centers in Norway, Sweden, Denmark, Finland, Estonia, Latvia, Lithuania, United Kingdom, Switzerland and New Zealand.

Being tested
Tenecteplase, Control
Keywords
ischemic stroke, wake-up, thrombolysis, tenecteplase, computed tomography
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TenecteplaseDrug

    Also called Metalyse

    Single dose intravenous injection of recombinant fibrin-specific tissue plasminogen activator (tenecteplase) 0.25 mg (200 IU) per kg body weight up to a maximum of 25 mg (5000 IU), given as a bolus over approx. 10 seconds.

  • ControlOther

    Best standard treatment

Study groups in NCT03181360
Study groupRoleWhat they receive
TenecteplaseActive comparatorTenecteplase + Best standard treatment
Receives: Drug: Tenecteplase
ControlOtherNo tenecteplase + Best standard treatment
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional outcome at 3 months.

    Functional outcome will be assessed by the modified Rankin Scale (mRS), values 0-6

    Measured: 3 months

Secondary outcomes (10)

  1. Symptomatic intracranial haemorrhage during the first 7 days.

    1. Symptoms (neurological deterioration, new headache, new acute hypertension, new nausea or vomiting, or sudden decrease in conscious level).
    2. Intracranial haemorrhage on brain MRI or CT.

    Measured: First 7 days

  2. Asymptomatic intracranial haemorrhage during the first 7 days.

    Intracranial haemorrhage on brain MRI or CT without: neurological deterioration, new headache, new acute hypertension, new nausea or vomiting or sudden decrease in consciousness level.

    Measured: First 7 days

  3. Recurrent ischaemic stroke during the first 7 days

    Neurological deterioration (increase of ≥2 on NIHSS, after exclusion of other causes for neurological deterioration) occurring after 72 hours will be considered as a recurrent stroke. A recurrent stroke will be classified as ischaemic if imaging has excluded haemorrhage.

    Measured: First 7 days

  4. Death from all cause

    Death will be classified according to cause:

    1. Initial stroke
    2. Recurrent stroke
    3. Myocardial infarction
    4. Pneumonia
    5. Other

    Measured: First 7 days

  5. Death from all cause

    Death will be classified according to cause:

    1. Initial stroke
    2. Recurrent stroke
    3. Myocardial infarction
    4. Pneumonia
    5. Other

    Measured: 3 months

  6. Barthel Index score

    Ordinal scale for measuring performance in activities of daily living

    Measured: 3 months

  7. EuroQol Score (EQ-5D)

    Measure of health-related quality of life

    Measured: 3 months

  8. Mini Mental State Examination

    30-point questionnaire for measurement of cognitive impairment

    Measured: 3 months

  9. Health-economic variables

    Costs related to length of hospital stay, nursing home care after discharge, re-hospitalisations during first 3 months

    Measured: 3 months

  10. Functional outcome at 3 months

    Functional outcome assessed by dichotomized mRS; values 0-1 vs 2-6.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2017
  2. Study start12 Jun 2017
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03181360
Sponsor's protocol ID
2015/1070/REC North
Other IDs
2014-000096-80, 2014
Acronym
TWIST
Status last verified
May 2021
First submitted
6 Jun 2017
Last updated
14 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Roaldsen MB, Eltoft A, Wilsgaard T, Christensen H, Engelter ST, Indredavik B, Jatuzis D, Karelis G, Korv J, Lundstrom E, Petersson J, Putaala J, Soyland MH, Tveiten A, Bivard A, Johnsen SH, Mazya MV, Werring DJ, Wu TY, De Marchis GM, Robinson TG, Mathiesen EB; TWIST Investigators. Safety and efficacy of tenecteplase in patients with wake-up stroke assessed by non-contrast CT (TWIST): a multicentre, open-label, randomised controlled trial. Lancet Neurol. 2023 Feb;22(2):117-126. doi: 10.1016/S1474-4422(22)00484-7. Epub 2022 Dec 19.

    PubMed 36549308

  • Eltoft A, Wilsgaard T, Roaldsen MB, Soyland MH, Lundstrom E, Petersson J, Indredavik B, Putaala J, Christensen H, Korv J, Jatuzis D, Engelter ST, De Marchis GM, Werring DJ, Robinson T, Tveiten A, Mathiesen EB. Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST). Trials. 2022 May 19;23(1):421. doi: 10.1186/s13063-022-06301-0.

    PubMed 35590386

  • Roaldsen MB, Lindekleiv H, Eltoft A, Jusufovic M, Soyland MH, Petersson J, Indredavik B, Tveiten A, Putaala J, Christensen H, Korv J, Jatuzis D, Engelter ST, Marco De Marchis G, Wilsgaard T, Werring DJ, Robinson T, Mathiesen EB, Berge E. Tenecteplase in wake-up ischemic stroke trial: Protocol for a randomized-controlled trial. Int J Stroke. 2021 Oct;16(8):990-994. doi: 10.1177/1747493020984073. Epub 2021 Jan 14.

    PubMed 33446083

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tenecteplase in people with Ischemic Stroke and Stroke, Acute, run by University Hospital of North Norway at 83 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United Kingdom, Norway, Sweden, Finland, Lithuania and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Melinda B Roaldsen, MD (+47 77627120, melinda.b.roaldsen@uit.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional outcome at 3 months. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03181360, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.

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