Clinical Research Directory
Browse clinical research sites, groups, and studies.
Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake
Sponsor: Insel Gruppe AG, University Hospital Bern
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
906
Start Date
2025-03-14
Completion Date
2029-04-30
Last Updated
2025-03-30
Healthy Volunteers
No
Conditions
Interventions
Tenecteplase or Alteplase
Patients randomized to intravenous thrombolysis (IVT) treatment will receive intravenous Tenecteplase or Alteplase.
Locations (14)
UZ Leuven
Leuven, Belgium
Hamilton Health Sciences
Hamilton, Ontario, Canada
GHU Paris Psychiatrie et Neurosciences, Sainte Anne
Paris, France
Heidelberg University Hospital
Heidelberg, Germany
"Attikon" University Hospital
Athens, Greece
National Cerebral and Cardiovascular Center Osaka
Osaka, Kansai, Japan
Academic Medical Center Amsterdam, Department of Neurology
Amsterdam, Netherlands
Canterbury District Health Board
Christchurch, New Zealand
Akershus Hospital
Oslo, Norway
Lisbon Central University Hospital Centre
Lisbon, Portugal
Vall d'Hebron Stroke Center
Barcelona, Spain
University Hospital Basel
Basel, Switzerland
Inselspital Bern
Bern, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland