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Studies

Interventional Recruiting Phase 4

NCT06571149 on ClinicalTrials.gov

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

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

  • Sponsor: University Hospital of Bern
  • Enrollment: 906 (Estimated)
  • Study start: 2025-03-14 (Actual)
  • Primary completion: 2029-01-31 (Estimated)
  • Study completion: 2029-04-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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 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

Intervention / Treatment

  • Drug: Tenecteplase or Alteplase

Primary Outcome Measures

  • Modified Rankin Scale (mRS) (90 days +/- 2 weeks after randomization)
    Modified Rankin Scale is a scale that runs from 0-6, running from perfect health without symptoms (0) to death (6).

Countries

Austria, Belgium, Canada, Finland, France, Germany, Greece, Netherlands, Norway, Portugal, Spain, Switzerland

Locations and Investigators

  • Hospital Universitari Dr. Josep Trueta, Girona, Spain
    • Yolanda, Silva Blas
  • Complejo Hospitalario Universitario a Coruña, A Coruña, Spain
    • Maria del Mar, Castellanos Rodrigo
  • Hospital Universitario Ramón y Cajal, Madrid, Spain
    • Jaime, Masjuan Vallejo
  • Hospital Universitario Miguel Servet, Zaragoza, Spain
    • Marta, Serrano
  • Vall d'Hebron Hospital Campus, Barcelona, Spain
    • Carlos, Molina
  • Hospital Germans Trias I Pujol, Badalona, Spain
    • Daniel, Santana Moreno
  • Hospital Virgen del Rocio, Sevilla, Spain
    • Francisco, Moniche
  • Hospital Clinico Universitario De Valladolid, Valladolid, Spain
    • Juan F., Arenillas Lara
  • Rijnstate Ziekenhuis Stichting, Arnhem, Netherlands
    • Doeschka, Ferro
  • University Medical Center Groningen, Groningen, Netherlands
    • Maarten, Uyttenboogaart
  • Fransciscus Gasthuis, Rotterdam, Netherlands
    • Kirsten, Dorresteijn
  • Albert Schweitzer Ziekenhuis, Dordrecht, Netherlands
    • Elles, Zock
  • Amphia Hospital, Amphia, Netherlands
    • Ishita, Miah
  • University Medical Center, Leiden, Netherlands
    • Nyika, Kruyt
  • Erasmus Medical Center, Rotterdam, Netherlands
    • Heleen, de Hertog
  • Isala Klinieken Stichting, Zwolle, Netherlands
    • Clemens, Kersten
  • St. Antonius Ziekenhuis, Nieuwegein, Netherlands
    • Joost, Kerklaan
  • OLVG, Amsterdam, Netherlands
    • Anne, van der Meij
  • Haga Ziekenhuis, Den Haag, Netherlands
    • Jurgen, Piet
  • Radboud University Nijmegen Medical Center, Nijmegen, Netherlands
    • Frank-Erik, de Leeuw
  • Haaglanden MC, HMC Westeinde, den Haag, Netherlands
    • Ido, van den Wijngaard
  • Amsterdam UMC Stichting, Amsterdam, Netherlands
    • Jonathan, Coutinho
  • University Medical Center Utrecht, Utrecht, Netherlands
    • Michiel, Poorthuis
  • University Medical Center, Maastricht, Netherlands
    • Inger, de Ridder
  • Catharina Ziekenhuis Stichting, Eindhoven, Netherlands
    • Inge, van Uden
  • Universität Leipzig, Medizinische Fakultät, Leipzig, Germany
    • Dominik, Michalski
  • Universitätsmedizin Frankfurt, Frankfurt, Germany
    • Jan Hendrik, Schäfer
  • Universitätsklinikum Freiburg, Freiburg, Germany
    • Jürgen, Bardutzky
  • Asklepios Kliniken Hamburg GmbH, Hamburg, Germany
    • Lars, Marquardt
  • Universitätsklinikum Gießen und Marburg GmbH, Gießen, Germany
    • Christian, Claudi
  • Knappschaft Kliniken Bottrop GmbH, Bottrop, Germany
    • Carsten, Eggers
  • RHÖN-KLINIKUM AG - Campus Bad Neustadt, Bad Neustadt a.d.Saale, Germany
    • Hassan, Soda
  • Klinikum der Universität München Großhadern, München, Germany
    • Lars, Kellert
  • Klinikum Kassel GmbH, Kassel, Germany
    • Christian, Roth
  • Universitätsklinikum Jena, Jena, Germany
    • Albrecht, Guenther
  • Universitätsmedizin Göttingen, Göttingen, Germany
    • Katrin, Wasser
  • HELIOS Klinik Schleswig GmbH, Schleswig, Germany
    • Frederick, Palm
  • Universitaetsklinikum Heidelberg AöR, Heidelberg, Germany
    • Jan, Purrucker
  • HELIOS Klinikum Erfurt GmbH, Erfurt, Germany
    • Andreas, Steinbrecher
  • St. Josef-Hospital, Bochum, Germany
    • Stephan, Salmen
  • Universitätsklinikum Tübingen, Tübingen, Germany
    • Annerose, Mengel
  • Universitätsklinikum des Saarlandes, Homburg, Germany
    • Yaroslav, Winter
  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Ludwigshafen Am Rhein, Germany
    • Simon, Nagel
  • Sana Kliniken Lübeck GmbH, Lübeck, Germany
    • Jens, Schaumberg
  • Universitätsklinikum Ulm, Ulm, Germany
    • Georg, Häusler
  • SRH Klinikum Karlsbad Langensteinbach GmbH, Karlsbad, Germany
    • Sibu, Mundi
  • Nordwest-Krankenhaus Sanderbusch, Sande, Germany
    • Pawel, Kermer
  • Akershus University Hospital, Oslo, Norway
    • Espen Saxhaug, Kristoffersen
  • CHU de Bordeaux, Hôpital Pellegrin, Bordeaux, France
    • Igor, Sibon
  • Hôpital Foch, Suresnes, France
    • Betrand, Lapergue

And 34 other sites.

Study Officials