AzTrials
AzTrials

Ischemic StrokePhase 4DO-ITNCT06571149

Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake

A Phase 4 study testing Tenecteplase or Alteplase in people with Ischemic Stroke, run by Insel Gruppe AG, University Hospital Bern at 109 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

DO-IT is an international, multicenter, prospective, two-arm, randomized, open label, blinded endpoint superiority trial determining the safety and efficacy of intravenous thrombolysis (IVT) in participants experiencing an acute ischemic stroke (AIS) with recent (within the last 48 hours) intake of direct oral… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Tenecteplase or Alteplase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
906 participants
Where
109 sitesin 12 countries
Study dates
14 Mar 2025to 30 Apr 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent (deferred consent when possible according to national legislation)
  • AIS eligible to receive intravenous alteplase/tenecteplase as per standard of care disabling according to the judgement of the treating physician
  • DOAC ingestion within 48 hours prior to enrollment, or patient with an ongoing prescription of DOAC but exact time point of last intake is unknown.
  • Either
  • Can be randomized within 4 hours 15 minutes and treated within 4 hours 30 minutes of last known well time OR
  • MRI showing a pattern of "DWI-FLAIR-mismatch", i.e. acute ischemic lesion visibly on DWI ("positive DWI") but no marked parenchymal hyperintensity visible on FLAIR ("negative FLAIR") indicative of an acute ischemic lesion ≤4.5 hours of age AND Treatment can be started within 4.5 hours of symptom recognition (e.g., awakening).

Who cannot join

  • Contra-indications to IVT by the current standard of care of the treating physicians with the exception of recent DOAC intake as specified above.
  • Intended reversal by specific or unspecific reversal agents
  • Pregnancy or lactating women. To be reasonable sure to exclude women with ongoing pregnancy, women are not considered of childbearing potential if they fulfill the following criteria
  • Age > 55 years OR
  • Age < 55 years and at least 12 months since last menstrual period OR
  • Have had a documented surgical sterilization
Show all 9Show fewer
  • Patient < 18 years of age (since the benefit of IVT is unproven in this population)
  • Since the benefit of IVT might be smaller in patients in which additional endovascular treatment is planned, the investigators will cap patients with intended mechanical thrombectomy at 20% of the trial population. If this number is reached, the following additional exclusion criterion will be applied:
  • Intended treatment with endovascular reperfusion strategies

Trial locations and contacts

109 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Thomas Meinel, MD, PhD contact

+41 31 66 4 25 67

thomas.meinel@insel.ch

Freschta Zipser-Mohammadzada, PhD contact

+41 31 63 2 60 83

nctu@insel.ch

109 sites in 12 countries

Germany26 sites, 26 recruiting

  • RHÖN-KLINIKUM AG - Campus Bad Neustadt

    Bad Neustadt an der Saale, 97616

    Manuela Kirchner, +49 9771 66 24335, Manuela.Kirchner@campus-nes.de

    Hassan Soda

    Recruiting

  • Sozialstiftung Bamberg

    Bamberg, 96049

    Nadia Pacho, +49951 503-16275, Nadia.Pacho@sozialstiftung-bamberg.de

    Oliver Menn

    Not yet recruiting

  • St. Josef-Hospital

    Bochum, 44791

    Stephan Salmen, +492345092420, Stephan.Salmen@ruhr-uni-bochum.de

    Stephan Salmen

    Recruiting

  • Knappschaft Kliniken Bottrop GmbH

    Bottrop, 46242

    Heike Wandhöfer, +492041151700, Heike.Wandhoefer@Knappschaft-Kliniken.de

    Carsten Eggers

    Recruiting

  • Helios Klinikum Erfurt GmbH

    Erfurt, 99089

    Susann Weinreich, +49 361 7816463, Susann.Weinreich@helios-gesundheit.de

    Andreas Steinbrecher

    Recruiting

  • Alfried Krupp Krankenhaus

    Essen, 45131

    Birgit Lyss, +49 201-434-41418, Birgit.Lyss@krupp-krankenhaus.de

    Roland Veltkamp

    Not yet recruiting

  • Universitätsmedizin Frankfurt

    Frankfurt, 60590

    Rohini Rangarajan, +49 69 6301 6395, Rohini.Rangarajan@unimedizin-ffm.de

    Jan Hendrik Schäfer

    Recruiting

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

    Ulrike Bergmann, +49 761 270 50010, ulrike.bergmann@uniklinik-freiburg.de

    Jürgen Bardutzky

    Recruiting

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen

    Yvonne Holderer, 4964198545301, Yvonne.Holderer@innere.med.uni-giessen.de

    Christian Claudi, MD

    Recruiting

  • Universitätsmedizin Göttingen, Abteilung Neurologie

    Göttingen

    Anna-Lena Heller, 0551- 3964252, annalena.heller@med.uni-goettingen.de

    Katrin Wasser, MD

    Recruiting

  • Asklepios Klinik Barmbek

    Hamburg, 22307

    Canan Kurnaz, +49 40 181882-2672, c.kurnaz@asklepios.com

    Carsten Pohlmann

    Not yet recruiting

  • Asklepios Klinik Wandsbek

    Hamburg

    Christel Donath Meyers, +49 40 1818 83 1304, c.donath@asklepios.com

    Lars Marquardt, MD

    Recruiting

  • Heidelberg University Hospital

    Heidelberg, 69120

    Jan C. Purrucker, MD

    Recruiting

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

    Sandra Paryjas, +496131172234, Sandra.Paryjas@uks.eu

    Yaroslav Winter

    Not yet recruiting

  • Universitätsklinikum Jena

    Jena, 07747

    Anna-Maria Raehse, +4936419323417, Anna-Maria.Raehse@med.uni-jena.de

    Albrecht Guenther

    Recruiting

  • SRH Klinikum Karlsbad-Langensteinbach GmbH

    Karlsbad, Baden-Wurttemberg, 76307

    Bernd Krög, +49 (0)7202 61- 7216, Bernd.Kroeg@srh.de

    Heike Seewald-Belanger, Heike.Seewald-Belanger@srh.de

    Recruiting

  • Klinikum Kassel

    Kassel, 34125

    Johannes Mattheaei, +495619804152, Johannes.Matthaei@gnh.net

    Michelle Probst, Michelle.Probst@gnh.net

    Recruiting

  • Universität Leipzig

    Leipzig, 04103

    Rita Lachmund, +49 341 97 24206, rita.lachmund@medizin.uni-leipzig.de

    Dominik Michalski

    Recruiting

  • Sana Kliniken Lübeck GmbH

    Lübeck, 23560

    Jens Schaumberg, +49 451 585 1731, jens.schaumberg@sana.de

    Jens Schaumberg

    Not yet recruiting

  • Klinikum der Stadt Ludwigshafen

    Ludwigshafen

    Susanne Streib, 0621-503-4286, STREIBS@KLILU.de

    Simon Nagel, MD

    Recruiting

  • Klinikum der Universität München

    München, 81377

    Ana Grujovic, +49 89 4400 73692, Ana.Grujovic@med.uni-muenchen.de

    Lars Kellert

    Recruiting

  • RoMed Klinikum Rosenheim Klinik

    Rosenheim, 83022

    Joji Kuramatsu, MD, +49 8031 365 3661, Joji.Kuramatsu@ro-med.de

    Not yet recruiting

  • Nordwest-Krankenhaus Sanderbusch

    Sande, 26452

    +49 4422 80 1401, c.eiben@friesland-kliniken.de

    Pawel Kermer

    Recruiting

  • Helios Klinik Schleswig GmbH, Klinik für Neurologie und Neurologische

    Schleswig

    Inguta Schmidt Schmidt, 49 4621 8121551, Inguta.Schmidt@helios-gesundheit.de

    Frederick Palm, MD

    Recruiting

  • Universitätsklinikum Tübingen, Abt. Neurologie mit Schwerpunkt neurovaskuläre Erkrankungen

    Tübingen

    Julia Zeller, 0049 7071 29 85354, Julia.Zeller@med.uni-tuebingen.de

    Annerose Mengel, MD

    Recruiting

  • Universitätsklinikum Ulm

    Ulm, 89081

    Leonie Hartig, +49 731 177 12 01, Leonie.Hartig@uniklinik-ulm.de

    Karl Georg Häusler

    Recruiting

Other trials in Germany

Netherlands17 sites, 17 recruiting

  • OLVG location East

    Amsterdam, 1091

    Anne van der Meij, +31 20 599 9111, a.vandermeij@amsterdamumc.nl

    Not yet recruiting

  • Academic Medical Center Amsterdam, Department of Neurology

    Amsterdam, 1105

    Jonathan Coutinho, Dr. med.

    Recruiting

  • Rijnstate

    Arnhem, 6815

    Doeschka Ferro, MD, +31625323184, dferro@rijnstate.nl

    Recruiting

  • Amphia Hospital

    Breda, 4818

    Michel Remmers, +31765953026, mremmers@amphia.nl

    Ishita Miah, MD

    Recruiting

  • Albert Schweitzer ziekenhuis

    Dordrecht, 3318

    Elles Zock, +31 78 652 34 52, e.zock@asz.nl

    Not yet recruiting

  • Catharina Ziekenhuis

    Eindhoven, 5623

    Inge van Uden, +31 40 239 94 00, inge.v.uden@catharinaziekenhuis.nl

    Not yet recruiting

  • University Medical Center Groningen

    Groningen, 9700

    Maarten Uyttenboogaart, MD, +31503612400, m.uyttenboogaart@umcg.nl

    Recruiting

  • University Medical Center

    Leiden, 2333

    Ellis van Etten, +31715262197, e.s.van_etten@lumc.nl

    Nyika Kruyt, MD

    Recruiting

  • University Medical Center

    Maastricht, 6229

    Daisy Rentzing, Daisy.Rentzing@hagaziekenhuis.nl

    Inger de Ridder

    Not yet recruiting

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435

    Wouter Schonewille, +31 88 3203992, W.schonewille@antoniusziekenhuis.nl

    Joost Kerklaan, MD

    Not yet recruiting

  • Radboud University Nijmegen Medical Center

    Nijmegen, 6500

    Frank-Erik Deleeuw, +31 24 361 43 08, frankerik.deleeuw@radboudumc.nl

    Recruiting

  • Erasmus Medical Center

    Rotterdam, 3015

    Diederik Dippel, +31 61 435 89 78, d.dippel@erasmusmc.nl

    Heleen den Hertog

    Not yet recruiting

  • Franciscus Gasthuis

    Rotterdam, 3045

    Kirsten Dorresteijn, +31 108935744, k.dorresteijn@Franciscus.nl

    Not yet recruiting

  • Haaglanden MC, HMC Westeinde

    The Hague, 2512

    Tamara Dofferhoff, +31889792508, t.dofferhoff@haaglandenmc.nl

    Ido van den Wijngaard

    Recruiting

  • Haga Ziekenhuis

    The Hague, 6815

    Bas de Bruijn, +31702102381, s.debruijn@hagaziekenhuis.nl

    Jurgen Piet

    Recruiting

  • University Medical Center Utrecht

    Utrecht, 3584

    Berber Zweedijk, +31887565541, b.zweedijk@umcutrecht.nl

    Michiel Poorthuis

    Recruiting

  • Isala Hospital

    Zwolle, 8025

    Clemens Kersten, +31646155236, c.j.b.a.kersten@isala.nl

    Not yet recruiting

Other trials in Netherlands

France13 sites, 13 recruiting

  • CHU Bordeaux

    Bordeaux, 33000

    Sylvain Ledure, +33556795520, sylvain.ledure@chu-bordeaux.fr

    Igor Sibon

    Not yet recruiting

  • Chu Grenoble Alpes

    Grenoble, 38043

    Julien Colombat, +33476765789, JColombat@chu-grenoble.fr

    Olivier Detante

    Not yet recruiting

  • CHU de Lille

    Lille, 59037

    Emilie Verhoest, +33320446814, Emilie.VERHOEST@chu-lille.fr

    Nelly Dequatre

    Not yet recruiting

  • Hôpital Pierre Wertheimer

    Lyon, 69677

    Naoual El-jonhy, +33383858585, naoual.el-jonhy@chu-lyon.fr

    Tae-Hee Cho

    Not yet recruiting

  • CHU Montpellier

    Montpellier, 34 295

    Pauline Luchez, +33467330304, p-luchez@chu-montpellier.fr

    Caroline Arquizan

    Not yet recruiting

  • CHU Nancy

    Nancy, 54035

    Valérie Georges, +333 83 85 10 29, V.georges@chru-nancy.fr

    Sébastien Richard

    Not yet recruiting

  • AP-HP, Pitié-Salpêtrière

    Paris, 75013

    Charlotte Rosso, +33171970651, charlotte.rosso@aphp.fr

    Sonia Alamowitch

    Not yet recruiting

  • GHU Paris Psychiatrie et Neurosciences, Sainte Anne

    Paris, 75014

    Guillaume Turc, Dr. med.

    Recruiting

  • Hôpital Paris Saint-Joseph

    Paris, 75014

    Benjamin Maïer, +33144123857, bmaier@ghpsj.fr

    Benjamin Maïer

    Not yet recruiting

  • AP-HP, Lariboisière

    Paris, 75019

    Estelle Dubus, +33149956509, estelle.dubus@aphp.fr

    Mikael Mazighi

    Not yet recruiting

  • Perpignan Hospital Center

    Perpignan, 66000

    Sara Rivas-Lamelo, +33468616510, sara.rivas-lamelo@ch-perpignan.fr

    Denis Sablot

    Not yet recruiting

  • Hôpital de Hautepierre

    Strasbourg, 67098

    Matthieu Krug, +33388128606, matthieu.krug@chru-strasbourg.fr

    Valérie Wolff

    Not yet recruiting

  • Hôpital FOCH

    Suresnes, 92150

    Anaïs Beulaygue, +33146255973, a.beulaygue-larrusse@hopital-foch.com

    Bertrand Lapergue

    Not yet recruiting

Other trials in France

Switzerland13 sites, 13 recruiting

  • Kantonsspital Baden AG

    Baden, 5404

    Alexander Tarnutzer, +41 56 486 16 13, alexander.tarnutzer@access.uzh.ch

    Recruiting

  • University Hospital Basel

    Basel, 4031

    Thomas Pokorny, +41 61 328 59 85, thomas.pokorny@usb.ch

    Mira Katan, Prof.

    Recruiting

  • Inselspital Bern

    Bern, 3010

    Thomas Meinel, MD, PhD, 0041 31 63 2 91 86, thomas.meinel@insel.ch

    Thomas Meinel, MD, PhD

    Recruiting

  • MEDIN La Tour

    Biel, 2502

    Aleksandra Fréville, +41 32 324 44 22, AleksandraMagdalena.Freville@szb-chb.ch

    Pamela Correia

    Recruiting

  • Hôpitaux Universitaires Genève

    Geneva, 1205

    Emmanuel Carrera, +41 795533814, Emmanuel.Carrera@hcuge.ch

    Recruiting

  • Médecin Associé Service de Neurologie Département des Neurosciences Cliniques CHUV, BH13

    Lausanne, 1011

    Davide Strambo, +41 21 314 1190, strambodavide@gmail.com

    Recruiting

  • Luzerner Kantonsspital

    Lucerne, 6000

    Manuel Bolognese, +41 205 51 49, manuel.bolognese@luks.ch

    Recruiting

  • Ente Ospedaliero Cantonale Istituto di Neuroscienze Cliniche della Svizzera Italiana Stroke Center EOC, Clinica di Neurologia c/o Ospedale Regionale di Lugano, sede Civico

    Lugano, 6903

    Carlo Cereda, +41 91 811 66 91, Carlo.Cereda@eoc.ch

    Not yet recruiting

  • Neurologue FMH, AFC EEG/ENMG

    Nyon, 1260

    Guillermo Toledo, +41 22 994 64 38, guillermo.toledo@ghol.ch

    Julien Niederhäuser

    Recruiting

  • Kantonsspital St. Gallen

    Sankt Gallen

    Gian Marco De Marchis, Prof.

    Gian Marco De Marchis, Prof.

    Recruiting

  • Klinik Hirslanden

    Zurich, 8032

    Nils Peters, +41 44 387 39 95, Nils.Peters@hirslanden.ch

    Not yet recruiting

  • Stadtspital Zürich

    Zurich, 8063

    Marie-Luise Mono, +41 44 416 34 70, Marie-Luise.Mono@stadtspital.ch

    Recruiting

  • Universitätsspital Zürich

    Zurich, 8091

    Philipp Baumgartner, +41 44 255 55 11, Philipp.Baumgartner@usz.ch

    Recruiting

Other trials in Switzerland

Portugal9 sites, 9 recruiting

  • Hospital Amadora-Sintra Fernando Fonseca

    Amadora, 2720-276

    Teresa Mesquita, +351962387615, Teresa.mesquita@ulsasi.min-saude.pt

    Not yet recruiting

  • Hospitais da Universidade de Coimbra

    Coimbra, 3004-561

    João Freitas, +351917629589, joaosargentofreitas@chuc.min-saude.pt

    Not yet recruiting

  • Hospital Dr. Nélio Mendonça

    Funchal, 9000-177

    Tiago Freitas, +351964591644, esteves.freitas@gmail.com

    Recruiting

  • Lisbon Central University Hospital Centre

    Lisbon, 1150-199

    Diana Aguiar de Sousa, MD, PhD

    Recruiting

  • Hospital Egas Moinz

    Lisbon, 1449-005

    João P Marto, +351210432179, joao.pedro.seabra.marto@gmail.com

    Recruiting

  • Hospital Pedro Hispano

    Matosinhos Municipality, 4464-513

    Rita Brito, +351229391000, rita.brito@astrumcro.com

    Vítor T. Cruz

    Recruiting

  • Hospital de Santo António

    Porto, 4099-001

    Denis Gabriel, +351222077500, denisdegabriel@gmail.com

    Recruiting

  • ULS de Entre Douro e Vouga

    Porto, 4520-211

    Alice Coelho, +351256379700, alice.coelho@ulsedv.min-saude.pt

    Luís Fontão

    Recruiting

  • Hospital de São João

    Porto

    Luísa Fonseca, +351918080491, luisa.almeida@netcabo.pt

    Recruiting

Other trials in Portugal

Belgium8 sites, 8 recruiting

  • AZ Sint-Jan Brugge AV

    Bruges

    Liesbeth Laloo, +32 50 45 36 96, liesbeth.laloo@azsintjan.be

    Sofie Deblauwe

    Recruiting

  • Cliniques Universitaires de Bruxelles

    Brussels

    Patrick Lamotte, +32 (0)2 555 51 52

    Noemi Ligot, MD

    Recruiting

  • UCL St Luc

    Brussels

    Ayhan Findik, +32 2 764 1080, ayhan.findik@saintluc.uclouvain.be

    Pasquale Scoppettuolo, MD

    Recruiting

  • Hôpital Civil Marie Curie

    Charleroi

    Flavio Bellante, +32 9 332 45 29, Flavio.BELLANTE@humani.be

    Flavio Bellante, MD

    Recruiting

  • University Hospital Gent

    Ghent

    Wendy Stoop, +32 9 332 04 49, wendy.stoop@uzgent.be

    Dimitri M. Hemelsoet, MD

    Recruiting

  • AZ Groeninge, Campus Kennedy

    Kortrijk

    Shauni Vandenbulcke, +32 2 555 6551, shauni.vandenbulcke@azgroeninge.be

    Peter Vanacker, MD

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Annemie Devroye, annemie.devroye@uzleuven.be

    Robin Lemmens, MD

    Recruiting

  • CHU de Liège

    Liège, 4000

    Simon Detriche, +32 4 323 66 84, sdetriche@chuliege.be

    Julien Ly

    Not yet recruiting

Other trials in Belgium

Spain8 sites, 8 recruiting

  • Complejo Hospitalario Universitario a Coruña

    A Coruña, Galicia

    Diego Otero, 34981176036, Diego.Otero.Tomera@sergas.es

    María del Mar Castellanos Rodrigo

    Recruiting

  • Vall d'Hebron Stroke Center

    Barcelona, 08035

    Carlos A. Molina, MD, PhD

    Recruiting

  • Germans Trias I Pujol Hospital Badalona

    Barcelona

    Lucia Muñoz Narbona, 34 93 497 89 11, lmunoz@igtp.cat

    Daniel Santana

    Recruiting

  • Hospital Universitari Dr. Josep Trueta

    Girona

    Yolanda Silva Blas, 34972940262, ysilva.girona.ics@gencat.cat

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid

    Dr. Jaime Masjuan Vallejo, 34 91 336 88 33, jaime.masjuan@salud.madrid.org

    Recruiting

  • Hospital Virgen del Rocio

    Seville

    Francicso Moniche, Dr., 34955012593, pmoniche@gmail.com

    Recruiting

  • Hospital Clínico Universitario Valladolid

    Valladolid

    Beatriz Gomez Vicente, 34 98 3420 000, beatrizgomezvicente@gmail.com

    Juan F. Arenillas

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza

    Marta Serrano, 34 976 76 55 00, mserranoponz@gmail.com

    Recruiting

Other trials in Spain

Austria6 sites, 6 recruiting

  • Barmherzige Brüder Krankenhaus Eisenstadt

    Eisenstadt, 7000

    Dimitre Staykov, 4326826013910, Dimitre.Staykov@bbeisen.at

    Dimitre Staykov

    Recruiting

  • Universitätsklinik für Neurologie Graz

    Graz, 8036

    Margit List-Schleich, +43 316 385 83 380, margit.list-schleich@medunigraz.at

    Thomas Gattringer

    Recruiting

  • Medical University of Innsbruck

    Innsbruck, 6020

    Christian Boehme, +43 512 504 83505, christian.boehme@i-med.ac.at

    Christian Boehme

    Not yet recruiting

  • Christian Doppler Klinik

    Salzburg, 5020

    Bethseba Agola, +435725556039, CDK-Studien@salk.at

    Sebastian Mutzenbach

    Recruiting

  • Barmherzige Brüder Krankenhaus Wien

    Vienna, 1020

    lisa Kaindl, +431211215183, lisa.kaindl@gmail.com

    Marek Sykora

    Recruiting

  • Medizinische Universität Wien

    Vienna, 1090

    Martha Marko, +4314040031200, martha.marko@meduniwien.ac.at

    Stefan Greisenegger

    Recruiting

Other trials in Austria

Greece6 sites, 6 recruiting

  • Department of Neurology University Hospital of Alexandroupolis Democritus University of Thrace

    Alexandroupoli, 68100

    Konstantinos Vadikolias, MD, kvadikol@med.duth.gr

    Not yet recruiting

  • Eginition Hospital

    Athens, 11528

    Sofia Vassilopoulou, +30 2107289290, svassilopoulou@gmail.com

    Not yet recruiting

  • "Attikon" University Hospital

    Athens, 12462

    Georgios Tsivgoulis, MD, PhD

    Not yet recruiting

  • Department of Neurology, School of Medicine University of Crete

    Heraklion, 71500

    Panayiotis D. Mitsias, MD, +302810394839, pmitsias@uoc.gr

    Not yet recruiting

  • University General Hospital of Patras

    Pátrai, 265 04

    John Ellul, MD, +302610999571, ellul@upatras.gr

    Not yet recruiting

  • 2nd Department of Neurology, School of Medicine Faculty of Health Sciences, Aristotle University of Thessaloniki

    Thessaloniki, 546 36

    Theodoros Karapanayiotides, MD, +306937037253, tkarapanayiotides@yahoo.gr

    Not yet recruiting

Other trials in Greece

Canada1 site, 1 recruiting

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2

    Luciana Catanese, MD

    Not yet recruiting

Other trials in Canada

Finland1 site, 1 recruiting

  • Helsinki University Central Hospital

    Helsinki, 00290

    Jaana Koski, +358 9 471 72662, jaana.koski@hus.fi

    Daniel Strbian

    Recruiting

Other trials in Finland

Norway1 site, 1 recruiting

  • Akershus Hospital

    Oslo

    Espen Kristoffersen, MD

    Espen Kristoffersen

    Recruiting

Other trials in Norway

About this study

Official title: Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke on Treatment With Direct Oral Anticoagulants: DO-IT - The DOAC Intravenous Thrombolysis Trial

DO-IT is an international, multicenter, prospective, two-arm, randomized, open label, blinded endpoint superiority trial determining the safety and efficacy of intravenous thrombolysis (IVT) in participants experiencing an acute ischemic stroke (AIS) with recent (within the last 48 hours) intake of direct oral anticoagulant (DOAC). For this purpose, 906 adult participants experiencing an AIS with recent DOAC intake will be enrolled at several high-volume international stroke centers and randomly assigned in a ratio of 1:1 to one of two treatment arms: (1) IVT and standard of care/best medical treatment or (2) standard of care/best medical treatment. The DO-IT trial is a definitive test of the hypothesis that IVT is superior to standard of care for achieving better outcome at 90 days in AIS participants with recent DOAC intake.

Conditions
Ischemic Stroke
Being tested
Tenecteplase or Alteplase
Keywords
DOAC, NOAC (Novel Oral Anticoagulants), Anticoagulation, r-tPA (tissue-type plasminogen activator), Alteplase, Tenecteplase, Rivaroxaban, Apixaban, Dabigatran, Edoxaban
Medical subject headings
Ischemic Stroke

What participants receive

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

  • Tenecteplase or AlteplaseDrug

    Patients randomized to intravenous thrombolysis (IVT) treatment will receive intravenous Tenecteplase or Alteplase.

Study groups in NCT06571149
Study groupRoleWhat they receive
Best Medical Treatment (standard of care)No interventionPatients will receive Standard of care/Best medical treatment according to local applicable guidelines, including the current American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation/ European Society of Minimally Invasive Neurological Therapy (ESO/ESMINT) guidelines.
Intravenous Thrombolysis + Best medical treatment (standard of care)ExperimentalPatients will receive intravenous administration of Tenecteplase or Alteplase.
Receives: Drug: Tenecteplase or Alteplase

What is being measured

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

  1. Modified Rankin Scale (mRS)

    Modified Rankin Scale is a scale that runs from 0-6, running from perfect health without symptoms (0) to death (6).

    Measured: 90 days +/- 2 weeks after randomization

Secondary outcomes (3)

  1. Dichotomized modified Rankin Scale (mRS) 0-2 (good functional outcome)

    Modified Rankin Scale is a scale that runs from 0-6, running from perfect health without symptoms (0) to death (6).

    Measured: 90 days +/- 2 weeks post-randomization

  2. Change from baseline in stroke severity (National Institutes of Health Stroke Scale, NIHSS)

    The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. Thus, 0 (minimum score) means "no symptoms", whereas 42 (maximum score) means "severe stroke".

    Measured: 24 +/- 12 hours after Intervention

  3. Health-related Quality of Life (EuroQol 5D-3L questionnaire)

    The EuroQol 5D-3L (EuroQol 5 Dimensions with each 3 Levels) measures health-related Quality of Life.

    Measured: 90 days +/- 2 weeks post-randomization

Timeline

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

  1. First posted26 Aug 2024
  2. Study start14 Mar 2025
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion30 Apr 2029 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
906 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06571149
Sponsor's protocol ID
2024-01157
Acronym
DO-IT
Status last verified
Jul 2026
First submitted
22 Aug 2024
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPDMA (individual participant data meta-analysis) of similar interventional clinical studies is planned.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tenecteplase or Alteplase in people with Ischemic Stroke, run by Insel Gruppe AG, University Hospital Bern at 109 sites in 12 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in Germany, Netherlands, France, Switzerland, Portugal and 7 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Thomas Meinel, MD, PhD (+41 31 66 4 25 67, thomas.meinel@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin Scale (mRS) (time frame: 90 days +/- 2 weeks after randomization). 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 NCT06571149.

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 30 Sep 2026.

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