RecruitingPhase 4NCT06571149

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

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

Insel Gruppe AG, University Hospital Bern

Enrollment

906 participants

Start Date

Mar 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Tenecteplase or Alteplase for people with ischemic stroke. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTenecteplase or Alteplase

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


Locations(102)

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

Vall d'Hebron Stroke Center

Barcelona, 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

Hospital de São João

Porto, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Klinik Hirslanden

Zurich, Switzerland

Stadtspital Zürich

Zurich, Switzerland

Universitätsspital Zürich

Zurich, Switzerland

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NCT06571149


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