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Clinical Trials in Canada / NCT06571149
Recruiting Phase 4

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

NCT06571149 · tracked via the Priya Life Science Canada tracker
Phase
Phase 4
Started
2025-03-14
Last updated
2026-08-03

Condition(s) studied

Ischemic Stroke

Investigational drug(s) / intervention(s)

Tenecteplase or AlteplaseAll Tenecteplase trials (24) →All Alteplase trials (10) →

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (102)

FacilityCityRegionStatus
Barmherzige Brüder Krankenhaus Eisenstadt Eisenstadt Austria Recruiting
Universitätsklinik für Neurologie Graz Graz Austria Recruiting
Medical University of Innsbruck Innsbruck Austria Not Yet Recruiting
Christian Doppler Klinik Salzburg Austria Recruiting
Barmherzige Brüder Krankenhaus Wien Vienna Austria Recruiting
Medizinische Universität Wien Vienna Austria Recruiting
AZ Sint-Jan Brugge AV Bruges Belgium Recruiting
Cliniques Universitaires de Bruxelles Brussels Belgium Recruiting
UCL St Luc Brussels Belgium Recruiting
Hôpital Civil Marie Curie Charleroi Belgium Recruiting
University Hospital Gent Ghent Belgium Recruiting
AZ Groeninge, Campus Kennedy Kortrijk Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
CHU de Liège Liège Belgium Not Yet Recruiting
Hamilton Health Sciences Hamilton Ontario Not Yet Recruiting
Helsinki University Central Hospital Helsinki Finland Recruiting
CHU Bordeaux Bordeaux France Not Yet Recruiting
Chu Grenoble Alpes Grenoble France Not Yet Recruiting
CHU de Lille Lille France Not Yet Recruiting
Hôpital Pierre Wertheimer Lyon France Not Yet Recruiting
CHU Montpellier Montpellier France Not Yet Recruiting
CHU Nancy Nancy France Not Yet Recruiting
AP-HP, Pitié-Salpêtrière Paris France Not Yet Recruiting
GHU Paris Psychiatrie et Neurosciences, Sainte Anne Paris France Recruiting
Hôpital Paris Saint-Joseph Paris France Not Yet Recruiting
AP-HP, Lariboisière Paris France Not Yet Recruiting
Perpignan Hospital Center Perpignan France Not Yet Recruiting
Hôpital de Hautepierre Strasbourg France Not Yet Recruiting
Hôpital FOCH Suresnes France Not Yet Recruiting
SRH Klinikum Karlsbad-Langensteinbach GmbH Karlsbad Baden-Wurttemberg Recruiting
RHÖN-KLINIKUM AG - Campus Bad Neustadt Bad Neustadt an der Saale Germany Recruiting
Sozialstiftung Bamberg Bamberg Germany Not Yet Recruiting
St. Josef-Hospital Bochum Germany Recruiting
Knappschaft Kliniken Bottrop GmbH Bottrop Germany Recruiting
Helios Klinikum Erfurt GmbH Erfurt Germany Recruiting
Alfried Krupp Krankenhaus Essen Germany Not Yet Recruiting
Universitätsmedizin Frankfurt Frankfurt Germany Recruiting
Universitätsklinikum Freiburg Freiburg im Breisgau Germany Recruiting
Universitätsklinikum Gießen und Marburg GmbH Giessen Germany Recruiting
Universitätsmedizin Göttingen, Abteilung Neurologie Göttingen Germany Recruiting

+ 62 more sites — see the full list on the official registry below.

More Insel Gruppe AG, University Hospital Bern trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06571149 on ClinicalTrials.gov ↗ ← All trials in Canada