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.
Barmherzige Brüder Krankenhaus Eisenstadt
Eisenstadt, Austria
RECRUITINGUniversitätsklinik für Neurologie Graz
Graz, Austria
RECRUITINGMedical University of Innsbruck
Innsbruck, Austria
NOT_YET_RECRUITINGChristian Doppler Klinik
Salzburg, Austria
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.
Barmherzige Brüder Krankenhaus Wien
Vienna, Austria
RECRUITINGMedizinische Universität Wien
Vienna, Austria
RECRUITINGAZ Sint-Jan Brugge AV
Bruges, Belgium
RECRUITINGCliniques Universitaires de Bruxelles
Brussels, Belgium
RECRUITINGUCL St Luc
Brussels, Belgium
RECRUITINGHôpital Civil Marie Curie
Charleroi, Belgium
RECRUITING...and 92 more locations