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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
906
Patients randomized to intravenous thrombolysis (IVT) treatment will receive intravenous Tenecteplase or Alteplase.
UZ Leuven
Leuven, Belgium
NOT_YET_RECRUITINGHamilton Health Sciences
Hamilton, Ontario, Canada
NOT_YET_RECRUITINGGHU Paris Psychiatrie et Neurosciences, Sainte Anne
Paris, France
NOT_YET_RECRUITINGHeidelberg University Hospital
Heidelberg, Germany
NOT_YET_RECRUITING"Attikon" University Hospital
Athens, Greece
NOT_YET_RECRUITINGNational Cerebral and Cardiovascular Center Osaka
Osaka, Kansai, Japan
NOT_YET_RECRUITINGAcademic Medical Center Amsterdam, Department of Neurology
Amsterdam, Netherlands
NOT_YET_RECRUITINGCanterbury District Health Board
Christchurch, New Zealand
NOT_YET_RECRUITINGAkershus Hospital
Oslo, Norway
NOT_YET_RECRUITINGLisbon Central University Hospital Centre
Lisbon, Portugal
NOT_YET_RECRUITING...and 4 more locations
Modified Rankin Scale (mRS)
Modified Rankin Scale is a scale that runs from 0-6, running from perfect health without symptoms (0) to death (6).
Time frame: 90 days +/- 2 weeks after randomization
Dichotomized modified Rankin Scale (mRS) 0-2 (good functional outcome)
Modified Rankin Scale is a scale that runs from 0-6, running from perfect health without symptoms (0) to death (6).
Time frame: 90 days +/- 2 weeks post-randomization
Change from baseline in stroke severity (National Institutes of Health Stroke Scale, NIHSS)
The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. Thus, 0 (minimum score) means "no symptoms", whereas 42 (maximum score) means "severe stroke".
Time frame: 24 +/- 12 hours after Intervention
Health-related Quality of Life (EuroQol 5D-3L questionnaire)
The EuroQol 5D-3L (EuroQol 5 Dimensions with each 3 Levels) measures health-related Quality of Life.
Time frame: 90 days +/- 2 weeks post-randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.