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RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Insel Gruppe AG, University Hospital Bern • ClinicalTrials.gov ID: NCT06571149

Registry updated: 2026-09-30
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Description

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.

Interventions

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

Eligibility criteria

Inclusion Criteria: * 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). Exclusion Criteria: * 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 * 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

Conditions

Ischemic Stroke

Locations

  • Barmherzige Brüder Krankenhaus Eisenstadt — Eisenstadt, Austria
  • Universitätsklinik für Neurologie Graz — Graz, Austria
  • Medical University of Innsbruck — Innsbruck, Austria
  • Christian Doppler Klinik — Salzburg, Austria
  • Barmherzige Brüder Krankenhaus Wien — Vienna, Austria
  • Medizinische Universität Wien — Vienna, Austria
  • AZ Sint-Jan Brugge AV — Bruges, Belgium
  • Cliniques Universitaires de Bruxelles — Brussels, Belgium
  • UCL St Luc — Brussels, Belgium
  • Hôpital Civil Marie Curie — Charleroi, Belgium
  • University Hospital Gent — Ghent, Belgium
  • AZ Groeninge, Campus Kennedy — Kortrijk, Belgium
  • UZ Leuven — Leuven, Belgium
  • CHU de Liège — Liège, Belgium
  • Hamilton Health Sciences — Hamilton, Ontario, Canada
  • Helsinki University Central Hospital — Helsinki, Finland
  • CHU Bordeaux — Bordeaux, France
  • Chu Grenoble Alpes — Grenoble, France
  • CHU de Lille — Lille, France
  • Hôpital Pierre Wertheimer — Lyon, France
  • CHU Montpellier — Montpellier, France
  • CHU Nancy — Nancy, France
  • AP-HP, Pitié-Salpêtrière — Paris, France
  • GHU Paris Psychiatrie et Neurosciences, Sainte Anne — Paris, France
  • Hôpital Paris Saint-Joseph — Paris, France
  • AP-HP, Lariboisière — Paris, France
  • Perpignan Hospital Center — Perpignan, France
  • Hôpital de Hautepierre — Strasbourg, France
  • Hôpital FOCH — Suresnes, France
  • SRH Klinikum Karlsbad-Langensteinbach GmbH — Karlsbad, Baden-Wurttemberg, Germany
  • RHÖN-KLINIKUM AG - Campus Bad Neustadt — Bad Neustadt an der Saale, Germany
  • Sozialstiftung Bamberg — Bamberg, Germany
  • St. Josef-Hospital — Bochum, Germany
  • Knappschaft Kliniken Bottrop GmbH — Bottrop, Germany
  • Helios Klinikum Erfurt GmbH — Erfurt, Germany
  • Alfried Krupp Krankenhaus — Essen, Germany
  • Universitätsmedizin Frankfurt — Frankfurt, Germany
  • Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany
  • Universitätsklinikum Gießen und Marburg GmbH — Giessen, Germany
  • Universitätsmedizin Göttingen, Abteilung Neurologie — Göttingen, Germany
  • Asklepios Klinik Barmbek — Hamburg, Germany
  • Asklepios Klinik Wandsbek — Hamburg, Germany
  • Heidelberg University Hospital — Heidelberg, Germany
  • Universitätsklinikum des Saarlandes — Homburg, Germany
  • Universitätsklinikum Jena — Jena, Germany
  • Klinikum Kassel — Kassel, Germany
  • Universität Leipzig — Leipzig, Germany
  • Klinikum der Stadt Ludwigshafen — Ludwigshafen, Germany
  • Sana Kliniken Lübeck GmbH — Lübeck, Germany
  • Klinikum der Universität München — München, Germany
  • RoMed Klinikum Rosenheim Klinik — Rosenheim, Germany
  • Nordwest-Krankenhaus Sanderbusch — Sande, Germany
  • Helios Klinik Schleswig GmbH, Klinik für Neurologie und Neurologische — Schleswig, Germany
  • Universitätsklinikum Tübingen, Abt. Neurologie mit Schwerpunkt neurovaskuläre Erkrankungen — Tübingen, Germany
  • Universitätsklinikum Ulm — Ulm, Germany
  • Department of Neurology University Hospital of Alexandroupolis Democritus University of Thrace — Alexandroupoli, Greece
  • Eginition Hospital — Athens, Greece
  • "Attikon" University Hospital — Athens, Greece
  • Department of Neurology, School of Medicine University of Crete — Heraklion, Greece
  • University General Hospital of Patras — Pátrai, Greece
  • 2nd Department of Neurology, School of Medicine Faculty of Health Sciences, Aristotle University of Thessaloniki — Thessaloniki, Greece
  • OLVG location East — Amsterdam, Netherlands
  • Academic Medical Center Amsterdam, Department of Neurology — Amsterdam, Netherlands
  • Rijnstate — Arnhem, Netherlands
  • Amphia Hospital — Breda, Netherlands
  • Albert Schweitzer ziekenhuis — Dordrecht, Netherlands
  • Catharina Ziekenhuis — Eindhoven, Netherlands
  • University Medical Center Groningen — Groningen, Netherlands
  • University Medical Center — Leiden, Netherlands
  • University Medical Center — Maastricht, Netherlands
  • St. Antonius Ziekenhuis — Nieuwegein, Netherlands
  • Radboud University Nijmegen Medical Center — Nijmegen, Netherlands
  • Erasmus Medical Center — Rotterdam, Netherlands
  • Franciscus Gasthuis — Rotterdam, Netherlands
  • Haaglanden MC, HMC Westeinde — The Hague, Netherlands
  • Haga Ziekenhuis — The Hague, Netherlands
  • University Medical Center Utrecht — Utrecht, Netherlands
  • Isala Hospital — Zwolle, Netherlands
  • Akershus Hospital — Oslo, Norway
  • Hospital Amadora-Sintra Fernando Fonseca — Amadora, Portugal
  • Hospitais da Universidade de Coimbra — Coimbra, Portugal
  • Hospital Dr. Nélio Mendonça — Funchal, Portugal
  • Lisbon Central University Hospital Centre — Lisbon, Portugal
  • Hospital Egas Moinz — Lisbon, Portugal
  • Hospital Pedro Hispano — Matosinhos Municipality, Portugal
  • Hospital de Santo António — Porto, Portugal
  • ULS de Entre Douro e Vouga — Porto, Portugal
  • Hospital de São João — Porto, Portugal
  • Complejo Hospitalario Universitario a Coruña — A Coruña, Galicia, Spain
  • Vall d'Hebron Stroke Center — Barcelona, Spain
  • Germans Trias I Pujol Hospital Badalona — Barcelona, Spain
  • Hospital Universitari Dr. Josep Trueta — Girona, Spain
  • Hospital Universitario Ramón y Cajal — Madrid, Spain
  • Hospital Virgen del Rocio — Seville, Spain
  • Hospital Clínico Universitario Valladolid — Valladolid, Spain
  • Hospital Universitario Miguel Servet — Zaragoza, Spain
  • Kantonsspital Baden AG — Baden, Switzerland
  • University Hospital Basel — Basel, Switzerland
  • Inselspital Bern — Bern, Switzerland
  • MEDIN La Tour — Biel, Switzerland
  • Hôpitaux Universitaires Genève — Geneva, Switzerland
  • Médecin Associé Service de Neurologie Département des Neurosciences Cliniques CHUV, BH13 — Lausanne, Switzerland
  • Luzerner Kantonsspital — Lucerne, Switzerland
  • 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, Switzerland
  • Neurologue FMH, AFC EEG/ENMG — Nyon, Switzerland
  • Kantonsspital St. Gallen — Sankt Gallen, Switzerland
  • Klinik Hirslanden — Zurich, Switzerland
  • Stadtspital Zürich — Zurich, Switzerland
  • Universitätsspital Zürich — Zurich, Switzerland
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record