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

Status: Recruiting
Location: See all (102) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Austria
Barmherzige Brüder Krankenhaus Eisenstadt
RECRUITING
Eisenstadt
Universitätsklinik für Neurologie Graz
RECRUITING
Graz
Medical University of Innsbruck
NOT_YET_RECRUITING
Innsbruck
Christian Doppler Klinik
RECRUITING
Salzburg
Barmherzige Brüder Krankenhaus Wien
RECRUITING
Vienna
Medizinische Universität Wien
RECRUITING
Vienna
Belgium
AZ Sint-Jan Brugge AV
RECRUITING
Bruges
Cliniques Universitaires de Bruxelles
RECRUITING
Brussels
UCL St Luc
RECRUITING
Brussels
Hôpital Civil Marie Curie
RECRUITING
Charleroi
University Hospital Gent
RECRUITING
Ghent
AZ Groeninge, Campus Kennedy
RECRUITING
Kortrijk
UZ Leuven
RECRUITING
Leuven
CHU de Liège
NOT_YET_RECRUITING
Liège
Canada
Hamilton Health Sciences
NOT_YET_RECRUITING
Hamilton
Finland
Helsinki University Central Hospital
RECRUITING
Helsinki
France
CHU Bordeaux
NOT_YET_RECRUITING
Bordeaux
Chu Grenoble Alpes
NOT_YET_RECRUITING
Grenoble
CHU de Lille
NOT_YET_RECRUITING
Lille
Hôpital Pierre Wertheimer
NOT_YET_RECRUITING
Lyon
CHU Montpellier
NOT_YET_RECRUITING
Montpellier
CHU Nancy
NOT_YET_RECRUITING
Nancy
AP-HP, Lariboisière
NOT_YET_RECRUITING
Paris
AP-HP, Pitié-Salpêtrière
NOT_YET_RECRUITING
Paris
GHU Paris Psychiatrie et Neurosciences, Sainte Anne
RECRUITING
Paris
Hôpital Paris Saint-Joseph
NOT_YET_RECRUITING
Paris
Perpignan Hospital Center
NOT_YET_RECRUITING
Perpignan
Hôpital de Hautepierre
NOT_YET_RECRUITING
Strasbourg
Hôpital FOCH
NOT_YET_RECRUITING
Suresnes
Germany
RHÖN-KLINIKUM AG - Campus Bad Neustadt
RECRUITING
Bad Neustadt An Der Saale
Sozialstiftung Bamberg
NOT_YET_RECRUITING
Bamberg
St. Josef-Hospital
RECRUITING
Bochum
Knappschaft Kliniken Bottrop GmbH
RECRUITING
Bottrop
Helios Klinikum Erfurt GmbH
RECRUITING
Erfurt
Alfried Krupp Krankenhaus
NOT_YET_RECRUITING
Essen
Universitätsmedizin Frankfurt
RECRUITING
Frankfurt
Universitätsklinikum Freiburg
RECRUITING
Freiburg Im Breisgau
Universitätsklinikum Gießen und Marburg GmbH
RECRUITING
Giessen
Universitätsmedizin Göttingen, Abteilung Neurologie
RECRUITING
Göttingen
Asklepios Klinik Barmbek
NOT_YET_RECRUITING
Hamburg
Asklepios Klinik Wandsbek
RECRUITING
Hamburg
Heidelberg University Hospital
RECRUITING
Heidelberg
Universitätsklinikum des Saarlandes
NOT_YET_RECRUITING
Homburg
Universitätsklinikum Jena
RECRUITING
Jena
SRH Klinikum Karlsbad-Langensteinbach GmbH
RECRUITING
Karlsbad
Klinikum Kassel
RECRUITING
Kassel
Universität Leipzig
RECRUITING
Leipzig
Sana Kliniken Lübeck GmbH
NOT_YET_RECRUITING
Lübeck
Klinikum der Stadt Ludwigshafen
RECRUITING
Ludwigshafen
Klinikum der Universität München
RECRUITING
München
RoMed Klinikum Rosenheim Klinik
NOT_YET_RECRUITING
Rosenheim
Nordwest-Krankenhaus Sanderbusch
RECRUITING
Sande
Helios Klinik Schleswig GmbH, Klinik für Neurologie und Neurologische
RECRUITING
Schleswig
Universitätsklinikum Tübingen, Abt. Neurologie mit Schwerpunkt neurovaskuläre Erkrankungen
RECRUITING
Tübingen
Universitätsklinikum Ulm
RECRUITING
Ulm
Greece
Department of Neurology University Hospital of Alexandroupolis Democritus University of Thrace
NOT_YET_RECRUITING
Alexandroupoli
Attikon University Hospital
NOT_YET_RECRUITING
Athens
Eginition Hospital
NOT_YET_RECRUITING
Athens
Department of Neurology, School of Medicine University of Crete
NOT_YET_RECRUITING
Heraklion
University General Hospital of Patras
NOT_YET_RECRUITING
Pátrai
2nd Department of Neurology, School of Medicine Faculty of Health Sciences, Aristotle University of Thessaloniki
NOT_YET_RECRUITING
Thessaloniki
Netherlands
Academic Medical Center Amsterdam, Department of Neurology
RECRUITING
Amsterdam
OLVG location East
NOT_YET_RECRUITING
Amsterdam
Rijnstate
RECRUITING
Arnhem
Amphia Hospital
RECRUITING
Breda
Albert Schweitzer ziekenhuis
NOT_YET_RECRUITING
Dordrecht
Catharina Ziekenhuis
NOT_YET_RECRUITING
Eindhoven
University Medical Center Groningen
RECRUITING
Groningen
University Medical Center
RECRUITING
Leiden
University Medical Center
NOT_YET_RECRUITING
Maastricht
St. Antonius Ziekenhuis
NOT_YET_RECRUITING
Nieuwegein
Radboud University Nijmegen Medical Center
RECRUITING
Nijmegen
Erasmus Medical Center
NOT_YET_RECRUITING
Rotterdam
Franciscus Gasthuis
NOT_YET_RECRUITING
Rotterdam
Haaglanden MC, HMC Westeinde
RECRUITING
The Hague
Haga Ziekenhuis
RECRUITING
The Hague
University Medical Center Utrecht
RECRUITING
Utrecht
Isala Hospital
NOT_YET_RECRUITING
Zwolle
Norway
Akershus Hospital
RECRUITING
Oslo
Portugal
Hospital Amadora-Sintra Fernando Fonseca
NOT_YET_RECRUITING
Amadora
Hospitais da Universidade de Coimbra
NOT_YET_RECRUITING
Coimbra
Hospital Dr. Nélio Mendonça
RECRUITING
Funchal
Hospital Egas Moinz
RECRUITING
Lisbon
Lisbon Central University Hospital Centre
RECRUITING
Lisbon
Hospital Pedro Hispano
RECRUITING
Matosinhos Municipality
Hospital de Santo António
RECRUITING
Porto
ULS de Entre Douro e Vouga
RECRUITING
Porto
Spain
Vall d'Hebron Stroke Center
NOT_YET_RECRUITING
Barcelona
Switzerland
Kantonsspital Baden AG
RECRUITING
Baden
University Hospital Basel
RECRUITING
Basel
Inselspital Bern
RECRUITING
Bern
MEDIN La Tour
RECRUITING
Biel
Hôpitaux Universitaires Genève
RECRUITING
Geneva
Médecin Associé Service de Neurologie Département des Neurosciences Cliniques CHUV, BH13
RECRUITING
Lausanne
Luzerner Kantonsspital
RECRUITING
Lucerne
Ente Ospedaliero Cantonale Istituto di Neuroscienze Cliniche della Svizzera Italiana Stroke Center EOC, Clinica di Neurologia c/o Ospedale Regionale di Lugano, sede Civico
NOT_YET_RECRUITING
Lugano
Neurologue FMH, AFC EEG/ENMG
RECRUITING
Nyon
Hospital de São João
RECRUITING
Porto
Kantonsspital St. Gallen
RECRUITING
Sankt Gallen
Klinik Hirslanden
NOT_YET_RECRUITING
Zurich
Stadtspital Zürich
RECRUITING
Zurich
Universitätsspital Zürich
RECRUITING
Zurich
Contact Information
Primary
Thomas Meinel, MD, PhD
thomas.meinel@insel.ch
+41 31 66 4 25 67
Backup
Freschta Zipser-Mohammadzada, PhD
nctu@insel.ch
+41 31 63 2 60 83
Time Frame
Start Date: 2025-03-14
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 906
Treatments
No_intervention: Best Medical Treatment (standard of care)
Patients 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.
Experimental: Intravenous Thrombolysis + Best medical treatment (standard of care)
Patients will receive intravenous administration of Tenecteplase or Alteplase.
Related Therapeutic Areas
Stroke
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov

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