Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST)

May 11, 2021 updated by: University Hospital of North Norway

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

Can tenecteplase given <4.5 hours of awakening improve functional outcome at 3 months?
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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Melinda B Roaldsen, MD
Phone Number: +47 77627120
Email: melinda.b.roaldsen@uit.no

Study Contact Backup

Name: Agnethe Eltoft, MD, PhD
Phone Number: +47 77698906
Email: agnethe.eltoft@unn.no

Study Locations

Denmark
- - København, Denmark, 2400
    - Recruiting
    - Bispebjerg Hospital
    - Contact:
      
      Hanne Christensen, MD, PhD
      
      Phone Number: +45 38 63 50 00
      
      Email: hanne.krarup.christensen@regionh.dk
  - Odense, Denmark
    - Recruiting
    - Odense University Hospital
    - Contact:
      
      Karen Ægidius
      
      Email: Karen.Lehrmann.AEgidius@rsyd.dk
    - Principal Investigator:
      
      Karen L. Ægidius, MD, PhD
Estonia
- - Pärnu, Estonia, 80010
    - Recruiting
    - Parnu Hospital
    - Contact:
      
      Katrin Antsov, MD
      
      Phone Number: +3724494800
      
      Email: katrin.antsov@ph.ee
    - Principal Investigator:
      
      Katrin Antsov, MD
  - Tallin, Estonia, 10617
    - Recruiting
    - West Tallin Central Hospital
    - Contact:
      
      Katrin Gross-Paju, MD
      
      Phone Number: +3726261314
      
      Email: katrin.gross-paju@keskhaigla.ee
    - Principal Investigator:
      
      Katrin Gross-Paju, MD
  - Tallinn, Estonia, 10138
    - Recruiting
    - East Tallin Central Hospital
    - Contact:
      
      Toomas Toomsoo, MD
      
      Phone Number: +3726661900
      
      Email: toomas.toomsoo@itk.ee
    - Principal Investigator:
      
      Toomas Toomsoo, MD
  - Tartu, Estonia, 51014
    - Recruiting
    - Tartu University Clinic
    - Contact:
      
      Janika Kõrv
      
      Phone Number: +372 731 811
      
      Email: janika.korv@kliinikum.ee
Finland
- - Helsinki, Finland
    - Recruiting
    - Helsinki University Hospital
    - Contact:
      
      Jukka Putaala, Md, PhD
      
      Email: jukka.putaala@hus.fi
  - Joensuu, Finland
    - Recruiting
    - Siun sote - Joint municipal authority for North Karelia social and health services
    - Contact:
      
      Sirpa Kaipiainen, MD
    - Principal Investigator:
      
      Jussi Sipilä, MD
  - Kouvola, Finland
    - Recruiting
    - Pohjois-Kymen sairaala
    - Contact:
      
      Tero Tapiola
      
      Phone Number: +358 5 352000
      
      Email: tero.tapiola@kouvola.fi
  - Vaasa, Finland, 65130
    - Recruiting
    - Central Hospital in Vaasa
    - Contact:
      
      Jukka Saarinen, MD
      
      Phone Number: +35863231111
      
      Email: jukka.saarinen@vshp.fi
    - Principal Investigator:
      
      Jukka Saarinen, MD
- Satakunta
  - Pori, Satakunta, Finland, 28500
    - Recruiting
    - Satakunta Central Hospital
    - Contact:
      
      Juha Puustinen, MD
      
      Phone Number: +358262771
      
      Email: juha.puustinen@satshp.fi
    - Principal Investigator:
      
      Juha Puustinen, MD
Latvia
- - Riga, Latvia
    - Not yet recruiting
    - Riga East University Hospital
    - Contact:
      
      Aleksejs Višņakovs
    - Principal Investigator:
      
      Guntis Karelis, MD
Lithuania
- - Alytus, Lithuania, 62114
    - Recruiting
    - Alytus S. Kudirkos Hospital
    - Contact:
      
      Juknelis Kestutis, MD
      
      Phone Number: +37031556301
      
      Email: jukneliskestutis@hotmail.com
    - Principal Investigator:
      
      Juknelis Kestutis, MD
  - Kaunas, Lithuania, 50009
    - Recruiting
    - Lithuanian University of Health Sciences Kauno klinikos
    - Contact:
      
      Daiva Rastenyte, MD
      
      Phone Number: +37037326467
      
      Email: daiva.rastenyte@kaunoklinikos.lt
    - Principal Investigator:
      
      Daiva Rastenyte, MD
  - Klaipėda, Lithuania
    - Recruiting
    - Klaipeda Seamen's Hospital
    - Contact:
      
      Robertas Urbutis, MD
      
      Phone Number: +370 46 491009
      
      Email: rourb@yahoo.com
    - Principal Investigator:
      
      Robertas Urbutis, MD
  - Vilnius, Lithuania, LT-04130
    - Recruiting
    - Republican Vilnius University hospital
    - Contact:
      
      Aleksandras Vilionskis, MD
      
      Email: aleksandras.vilionskis@gmail.com
  - Vilnius, Lithuania, LT-08661
    - Recruiting
    - Vilnius University Hospital
    - Contact:
      
      Dalius Jatuzis, MD, PhD
      
      Phone Number: +370 5 236 5000
      
      Email: dalius.jatuzis@santa.lt
New Zealand
- - Christchurch, New Zealand
    - Recruiting
    - Christchurch Hospital
    - Contact:
      
      Teddy Wu, MD, PhD
      
      Email: teddy.wu@cdhb.health.nz
    - Principal Investigator:
      
      Teddy Wu, MD, PhD
Norway
- - Arendal, Norway, 4838
    - Terminated
    - Sørlandet sykehus HF Arendal
  - Drammen, Norway, N-3004
    - Not yet recruiting
    - Drammen sykehus Vestre Viken HF
    - Contact:
      
      Karl-Friedrich Amthor, MD
      
      Phone Number: +47 91503525
      
      Email: karamt@vestreviken.no
    - Principal Investigator:
      
      Karl-Friedrich Amthor, MD
  - Flekkefjord, Norway, N-4400
    - Recruiting
    - Sørlandet Sykehus HF Flekkefjord
    - Contact:
      
      Rita Van Lessen, MD
      
      Phone Number: +47 91503738
      
      Email: rita.van.lessen@sshf.no
    - Principal Investigator:
      
      Rita Van Lessen, MD
  - Førde, Norway, N-6807
    - Recruiting
    - Helse Førde HF
    - Contact:
      
      Magdalena Stankiewicz, MD
      
      Phone Number: +47 57839000
      
      Email: magdalena.stankiewicz@helse-forde.no
    - Principal Investigator:
      
      Magdalena Stankiewicz, MD
  - Gravdal, Norway, N-8372
    - Recruiting
    - Nordlandssykehuset Lofoten Gravdal
    - Contact:
      
      Bettina Heermann, MD
      
      Phone Number: +47 76060100
      
      Email: bettina.heermann@nordlandssykehuset.no
    - Principal Investigator:
      
      Bettina Heermann, MD
  - Hammerfest, Norway, N-9601
    - Recruiting
    - Helse Finnmark Hammerfest
    - Contact:
      
      Svein A Størdahl, MD
      
      Phone Number: +47 78421000
      
      Email: svein.are.stordal@finnmarkssykehuset.no
    - Principal Investigator:
      
      Svein A Størdahl, MD
  - Harstad, Norway, 9480
    - Recruiting
    - University Hospital of North Norway, Harstad
    - Contact:
      
      Maria Fjellstad, MD
      
      Phone Number: +47 07766
      
      Email: maria.serafia.fjellstad@unn.no
    - Principal Investigator:
      
      Maria Fjellstad, MD
  - Kirkenes, Norway, N-9900
    - Not yet recruiting
    - Helse Finnmark HF Kirkenes
    - Contact:
      
      Tonje A Melum, MD
      
      Phone Number: +47 78421000
      
      Email: tonje.anita.melum@finnmarkssykehuset.no
    - Principal Investigator:
      
      Tonje A Melum, MD
  - Kristiansand, Norway, N-4604
    - Recruiting
    - Sørlandet sykehus Kristiansand HF
    - Contact:
      
      Arnstein Tveiten, MD, PhD
      
      Phone Number: +47 38074000
      
      Email: arnstein.tveiten@sshf.no
    - Contact:
      
      Mary-Helen Søyland, MD
      
      Phone Number: +47 38074000
      
      Email: mary-helen.soyland@sshf.no
    - Principal Investigator:
      
      Arnstein Tveiten, MD, PhD
  - Levanger, Norway, N-7601
    - Terminated
    - Sykehuset Levanger
  - Lørenskog, Norway, N-1478
    - Recruiting
    - Akershus universitetssykehus (Ahus)
    - Contact:
      
      Antje Reichenbach, MD
      
      Phone Number: +47 91502900
      
      Email: antje.reichenbach@ahus.no
    - Principal Investigator:
      
      Antje Reichenbach, MD
  - Mosjøen, Norway, N-8651
    - Withdrawn
    - Helgelandssykehuset Mosjøen
  - Narvik, Norway, N-8504
    - Recruiting
    - University Hospital of North Norway, Narvik
    - Contact:
      
      Arne Haavik, MD
      
      Phone Number: +47 76968000
      
      Email: arne.haavik@unn.no
    - Principal Investigator:
      
      Arne Haavik, MD
  - Sandvika, Norway, N-1346
    - Recruiting
    - Bærum sykehus Vestre Viken HF
    - Contact:
      
      Håkon Ihle-Hansen, MD
      
      Phone Number: +47 06780
      
      Email: haaihl@vestreviken.no
    - Principal Investigator:
      
      Håkon Ihle-Hansen, MD
  - Skien, Norway, N-3710
    - Recruiting
    - Sykehuset Telemark Skien
    - Contact:
      
      Håkon Tobro, MD
      
      Phone Number: +47 35003500
      
      Email: haa.tob@sthf.no
    - Principal Investigator:
      
      Håkon Tobro, MD
  - Stavanger, Norway, N-4068
    - Active, not recruiting
    - Stavanger Universitetssjukehus
  - Tromsø, Norway, N-9019
    - Recruiting
    - University Hospital of North Norway, Tromsø
    - Contact:
      
      Melinda B Roaldsen, MD
      
      Phone Number: +47 77627120
      
      Email: melinda.b.roaldsen@uit.no
    - Contact:
      
      Einar Bugge, MD, PhD
      
      Email: einar.bugge@unn.no
    - Principal Investigator:
      
      Agnethe Eltoft, MD, PhD
  - Trondheim, Norway, N-7006
    - Recruiting
    - St Olavs hospital
    - Contact:
      
      Gitta Rohweder, MD
      
      Phone Number: +47 81555815
      
      Email: gitta.rohweder@stolav.no
    - Contact:
      
      Bent Indredavik, MD, PhD
      
      Phone Number: +47 81555815
      
      Email: bent.indredavik@ntnu.no
    - Principal Investigator:
      
      Gitta Rohweder, MD
  - Ålesund, Norway, N-6026
    - Recruiting
    - Ålesund sjukehus Helse Møre og Romsdal
    - Contact:
      
      Yngve M Seljeseth, MD
      
      Phone Number: +47 70105000
      
      Email: Yngve.muller.seljeseth@helse-mr.no
    - Principal Investigator:
      
      Yngve M Seljeseth, MD
Sweden
- - Göteborg, Sweden, 413 45
    - Recruiting
    - Sahlgrenska Universitetssjukhuset
    - Contact:
      
      Jan-Erik Karlsson, MD
      
      Phone Number: +46 31 342 10 00
      
      Email: jan-erik.karlsson@vgregion.se
  - Hässleholm, Sweden, 281 25
    - Recruiting
    - Hässleholm Sjukhus
    - Contact:
      
      Magnus Esbjörnsson, MD
      
      Phone Number: +46 0451 29 60 60
      
      Email: Magnus.Esbjornsson@skane.se
  - Karlstad, Sweden, 65230
    - Recruiting
    - Central Hospital Karlstad
    - Contact:
      
      Felix Andler, MD
      
      Phone Number: +4654615000
      
      Email: Felix.Andler@liv.se
    - Principal Investigator:
      
      Felix Andler, MD
  - Lund, Sweden
    - Not yet recruiting
    - Skane University Hospital Lund
    - Contact:
      
      Gunnar Andsberg, MD
    - Principal Investigator:
      
      Gunnar Andsberg, MD
  - Malmö, Sweden, 221 85
    - Recruiting
    - Skane University Hospital Malmo
    - Contact:
      
      Jesper Petersson, MD, PhD
      
      Phone Number: +46 40331000
      
      Email: jesper.petersson@skane.se
  - Skövde, Sweden, 541 85
    - Recruiting
    - Skaraborg Hospital Skovde
    - Contact:
      
      Björn Cederin, MD
      
      Phone Number: +46500431000
      
      Email: bjorn.cederin@vgregion.se
    - Principal Investigator:
      
      Björn Cederin, MD
  - Solna, Sweden, 171 76
    - Withdrawn
    - Karolinska Sjukhuset
  - Stockholm, Sweden, 112 81
    - Not yet recruiting
    - Saint Goran Hospital
    - Contact:
      
      Jan Mathé, MD
      
      Phone Number: +46858701000
      
      Email: jan.mathe@capiostgoran.se
    - Principal Investigator:
      
      Jan Mathé, MD
  - Stockholm, Sweden, 18288
    - Recruiting
    - Danderyd Hospital
    - Contact:
      
      Elisabet Rooth, MD
      
      Phone Number: +46812355000
      
      Email: elisabet.anggardh-rooth@sll.se
    - Principal Investigator:
      
      Elisabet Rooth, MD
  - Uppsala, Sweden, 751 85
    - Recruiting
    - Akademiska Sjukhuset
    - Contact:
      
      Karl Sjölin, MD
      
      Phone Number: +46 18 611 00 00
      
      Email: karl.sjolin@gmail.com
  - Ängelholm, Sweden, 26281
    - Recruiting
    - Ängelholm Hospital
    - Contact:
      
      Björn Hedström, MD
      
      Phone Number: +4643181000
      
      Email: Bjorn.Hedstrom@skane.se
    - Principal Investigator:
      
      Björn Hedström, MD
Switzerland
- - Basel, Switzerland, 4031
    - Recruiting
    - University Hospital Basel
    - Contact:
      
      Gian M De Marchis, MD, MSc
      
      Phone Number: +41 61 265 25 25
      
      Email: gian.demarchis@usb.ch
  - Nyon, Switzerland
    - Recruiting
    - Groupement Hospitalier Ouest Lémanique
    - Contact:
      
      Julien Niederhauser, MD
      
      Email: julien.niederhauser@ghol.ch
    - Principal Investigator:
      
      Julien Niederhauser, MD
United Kingdom
- - Aberdeen, United Kingdom, AB25 2ZN
    - Not yet recruiting
    - Aberdeen Royal Infirmary
    - Principal Investigator:
      
      Mary Joan Macleod, MD
    - Contact:
      
      Mary Joan Macleod, MD
      
      Phone Number: +44 345 456 6000
      
      Email: m.j.macleod@abdn.ac.uk
  - Birkenhead, United Kingdom
    - Recruiting
    - Arrowe Park
    - Contact:
      
      Ruth Davies
      
      Email: ruth.davies@nhs.net
    - Principal Investigator:
      
      Ruth Davis, MD
  - Birmingham, United Kingdom
    - Recruiting
    - University Hospital Birmingham
    - Contact:
      
      Mark Willmot
      
      Email: mark.willmot@nhs.net
    - Principal Investigator:
      
      Mark Willmot, MD
  - Bournemouth, United Kingdom, BH7 7DW
    - Not yet recruiting
    - Royal Bournemoth and Christchurch Hospital
    - Contact:
      
      Oliver Hopper, MD
      
      Phone Number: +441202 303626
      
      Email: oliver.hopper@rbch.nhs.uk
    - Principal Investigator:
      
      Oliver Hopper, MD
  - Cambridge, United Kingdom, CB2 0QQ
    - Recruiting
    - Addenbrookes Hospital
    - Contact:
      
      Elizabeth Warburton, MD
      
      Phone Number: +44 1223 245151
      
      Email: elizabeth.warburton@addenbrookes.nhs.uk
    - Principal Investigator:
      
      Elizabeth Warburton, MD
  - Chester, United Kingdom, CH2 1UL
    - Recruiting
    - Countess Of Chester Hospital NHS Foundation Trust
    - Contact:
      
      Kausik Chatterjee
      
      Phone Number: +4412 44365000
      
      Email: kausikchatterjee@nhs.net
    - Principal Investigator:
      
      Kausik Chatterjee, MD
  - Coventry, United Kingdom
    - Recruiting
    - University Hospitals Coventry & Warwickshire
    - Contact:
      
      Usman Ghani, MD
      
      Email: usman.ghani@uhcw.nhs.uk
    - Principal Investigator:
      
      Usman Ghani, MD
  - Derby, United Kingdom, DE 22 3 NE
    - Recruiting
    - Royal Derby Hospital
    - Contact:
      
      Timothy England, MD
      
      Phone Number: +441332340131
      
      Email: timothy.england@nhs.net
    - Principal Investigator:
      
      Timothy England, MD
  - Edinburgh, United Kingdom, EH16 4SA
    - Not yet recruiting
    - Royal Infirmary of Edinburgh Hospital
    - Contact:
      
      William Whiteley, MD
      
      Phone Number: +44 131 536 1000
      
      Email: william.whiteley@ed.ac.uk
    - Principal Investigator:
      
      William Whiteley, MD
  - Exeter, United Kingdom, EX2 5DW
    - Recruiting
    - Royal Devon and Exeter Hospital
    - Contact:
      
      Martin James, MD
      
      Phone Number: +44 1392 411611
      
      Email: martinjames@nhs.net
    - Principal Investigator:
      
      Martin James, MD
  - Gloucester, United Kingdom
    - Recruiting
    - Gloucestershire Royal Hospital
    - Contact:
      
      Dipankar Dutta
      
      Email: dipankar.dutta@glos.nhs.uk
    - Principal Investigator:
      
      Dipankar Dutta, MD
  - Halifax, United Kingdom
    - Recruiting
    - Calderdale Royal Infirmary
    - Contact:
      
      Anand Nair
      
      Email: Anand.Nair@cht.nhs.uk
    - Principal Investigator:
      
      Anand Nair, MD
  - Kingston upon Hull, United Kingdom
    - Recruiting
    - Hull University Teaching Hospital
    - Contact:
      
      Emma Clarkson
      
      Email: emmap.clarkson@hey.nhs.uk
    - Principal Investigator:
      
      Emma Clarkson, MD
  - Leeds, United Kingdom
    - Recruiting
    - Leeds General Infirmary
    - Contact:
      
      Vasileios Papavasileiou
      
      Email: v.papavasileiou@nhs.net
    - Principal Investigator:
      
      Vasileios Papavasileiou, MD
  - Leicester, United Kingdom, LE1 5WW
    - Recruiting
    - Leicester Royal Infirmary
    - Contact:
      
      Thompson G Robinson, MD, PhD
      
      Email: tgr2@le.ac.uk
    - Contact:
      
      Lisa Manning, MD
      
      Email: lm313@le.ac.uk
  - Liverpool, United Kingdom
    - Not yet recruiting
    - Royal Liverpool University Hospital
    - Contact:
      
      Aravind Manoj
      
      Email: aravind.manoj@rlbuht.nhs.uk
    - Principal Investigator:
      
      Aravind Manoj, MD
  - London, United Kingdom, NW1 2BU
    - Recruiting
    - University College London
    - Contact:
      
      Richard Perry, MD
      
      Phone Number: +44 20 3456 7890
      
      Email: richard.perry@uclh.nhs.uk
    - Principal Investigator:
      
      Richard Perry, MD
  - London, United Kingdom
    - Recruiting
    - Royal London Hospital
    - Contact:
      
      Rachel Evans
      
      Email: rachel.evans60@nhs.net
    - Principal Investigator:
      
      Rachel Evans, MD
  - London, United Kingdom, W6 8RF
    - Recruiting
    - Charing Cross Hospital
    - Contact:
      
      Omid Halse, MD
      
      Phone Number: +44 20 3311 1234
      
      Email: Omid.Halse@imperial.nhs.uk
    - Principal Investigator:
      
      Omid Halse, MD
  - London, United Kingdom, SE5 9RS
    - Recruiting
    - King´s College Hospital
    - Contact:
      
      Lalit Kalra, MD
      
      Phone Number: +44 20 3299 9000
      
      Email: lalit.kalra@nhs.net
    - Principal Investigator:
      
      Lalit Kalra, MD
  - London, United Kingdom, SW17 0QT
    - Recruiting
    - St Georges Hospital
    - Contact:
      
      Barry Moynihan, MD
      
      Phone Number: +44 20 8672 1255
      
      Email: Barry.moynihan@stgeorges.nhs.uk
    - Principal Investigator:
      
      Barry Moynihan, MD
  - Luton, United Kingdom
    - Recruiting
    - Luton and Dunstable University Hospital
    - Contact:
      
      Sakthivel Sethuraman
      
      Email: sakthivel.sethuraman@ldh.nhs.uk
    - Principal Investigator:
      
      Sakthivel Sethuraman, MD
  - Morriston, United Kingdom, SA6 6NL
    - Recruiting
    - Morriston Hospital
    - Contact:
      
      Mushtaq Wani, MD
      
      Phone Number: +44 1792 702222
      
      Email: Mushtaq.Wani@wales.nhs.uk
    - Principal Investigator:
      
      Mushtaq Wani, MD
  - Newcastle Upon Tyne, United Kingdom, NE1 4LP
    - Recruiting
    - Royal Victoria Infirmary
    - Contact:
      
      Anand Dixit, MD
      
      Phone Number: +441912336161
      
      Email: Anand.dixit@nuth.nhs.uk
    - Principal Investigator:
      
      Anand Dixit, MD
  - Nottingham, United Kingdom, NG5 1PB
    - Recruiting
    - Nottingham City Hospital
    - Contact:
      
      Philip Bath, MD
      
      Phone Number: +441159691169
      
      Email: Philip.bath@nottingham.ac.uk
    - Principal Investigator:
      
      Philip Bath, MD
  - Salford, United Kingdom
    - Recruiting
    - Salford Royal Hospital
    - Contact:
      
      Bharath Cheripelli
      
      Email: bharath.cheripelli@srft.nhs.uk
    - Principal Investigator:
      
      Bharath Cheripelli, MD
  - Southampton, United Kingdom
    - Recruiting
    - Southhampton General Hospital
    - Contact:
      
      Richard Marigold
      
      Email: james.marigold@uhs.nhs.uk
    - Principal Investigator:
      
      Richard Marigold, MD
  - Stoke-on-Trent, United Kingdom
    - Recruiting
    - Royal Stoke University Hospital
    - Contact:
      
      Girish Muddegowda
      
      Email: girish.muddegowda2@uhnm.nhs.uk
    - Principal Investigator:
      
      Girish Muddegowda, MD
  - Taunton, United Kingdom
    - Recruiting
    - Musgrove Park Hospital
    - Contact:
      
      Dumin Karunatilake, MD
      
      Email: dumin.karunatilake@tst.nhs.uk
    - Principal Investigator:
      
      Dumin Karunatilake, MD
  - Yeovil, United Kingdom, BA21 4AT
    - Recruiting
    - Yeovil District Hospital
    - Principal Investigator:
      
      Khalid Rashed, MD
    - Contact:
      
      Khalid Rashed, MD
      
      Phone Number: +44 1935 475122
      
      Email: khalid.rashed@ydh.nhs.uk
- Mid Yorkshire
  - Wakefield, Mid Yorkshire, United Kingdom, WF1 4DG
    - Recruiting
    - Pinderfields Hospital
    - Contact:
      
      Michael Carpenter, MD
      
      Phone Number: +4484 48118110
      
      Email: michael.carpenter@midyorks.nhs.net
    - Principal Investigator:
      
      Michael Carpenter, MD
- Northumberland
  - Cramlington, Northumberland, United Kingdom
    - Not yet recruiting
    - Northumbria Specialist Emergency Care Hospital
    - Contact:
      
      Mark Garside
      
      Email: Mark.Garside@northumbria-healthcare.nhs.uk
    - Principal Investigator:
      
      Mark Garside, MD
United States
- Massachusetts
  - Worcester, Massachusetts, United States, 01655
    - Not yet recruiting
    - University of Massachusetts Medical School
    - Contact:
      
      Brian Silver, MD
      
      Phone Number: 508-334-5989
      
      Email: Brian.Silver@umassmemorial.org
    - Principal Investigator:
      
      Brian Silver, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.:
- 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Arms and Interventions

Participant Group / Arm Participant Group / Arm A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.	Intervention / Treatment Intervention / Treatment A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Tenecteplase Tenecteplase + Best standard treatment	Drug: Tenecteplase 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. Other Names: Metalyse
Other: Control No tenecteplase + Best standard treatment	Other: Control Best standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome at 3 months. Time Frame: 3 months	Functional outcome will be assessed by the modified Rankin Scale (mRS), values 0-6	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic intracranial haemorrhage during the first 7 days. Time Frame: First 7 days	Symptoms (neurological deterioration, new headache, new acute hypertension, new nausea or vomiting, or sudden decrease in conscious level). Intracranial haemorrhage on brain MRI or CT.	First 7 days
Asymptomatic intracranial haemorrhage during the first 7 days. Time Frame: 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.	First 7 days
Recurrent ischaemic stroke during the first 7 days Time Frame: 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.	First 7 days
Death from all cause Time Frame: First 7 days	Death will be classified according to cause: Initial stroke Recurrent stroke Myocardial infarction Pneumonia Other	First 7 days
Death from all cause Time Frame: 3 months	Death will be classified according to cause: Initial stroke Recurrent stroke Myocardial infarction Pneumonia Other	3 months
Barthel Index score Time Frame: 3 months	Ordinal scale for measuring performance in activities of daily living	3 months
EuroQol Score (EQ-5D) Time Frame: 3 months	Measure of health-related quality of life	3 months
Mini Mental State Examination Time Frame: 3 months	30-point questionnaire for measurement of cognitive impairment	3 months
Health-economic variables Time Frame: 3 months	Costs related to length of hospital stay, nursing home care after discharge, re-hospitalisations during first 3 months	3 months
Functional outcome at 3 months Time Frame: 3 months	Functional outcome assessed by dichotomized mRS; values 0-1 vs 2-6.	3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Collaborators

The Royal Norwegian Ministry of Health

Norwegian Health Association

UiT The Arctic University of Norway

Investigators

Principal Investigator: Ellisiv B Mathiesen, University Hospital of North Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2017

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

2015/1070/REC North
2014-000096-80 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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