The present trial is addressing the question if a biologically distinct subgroup of ischemic stroke patients without known atrial fibrillation at admission, selected by a cut-off level of MRproANP concentration, which represents a underlying increased risk of cardiac thrombogenicity, benefits from direct oral anticoagulation (DOAC) within 7 days of symptom onset versus standard of care (antiplatelet) as preventive treatment.
Three DOACs with marketing authorisation in Switzerland and the EU for the prevention of stroke and systemic embolism in patients with atrial fibrillation can be used. Eligible patients will be randomly assigned to either the standard of care (control) or the experimental (direct start with DOAC) arm with a ratio of 1:1. Each study participant will be observed during a follow up period within one year after index stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
620
Attikon University Hospital
Athens, Greece
RECRUITINGOslo University Hospital - Ullevål
Oslo, Norway
Recurrent stroke of any type
The primary outcome measure is the time to any recurrent stroke (ischemic, hemorrhagic, unspecified, or fatal stroke)
Time frame: within one year after index stroke
Composite of major bleeding, recurrent stroke and/or vascular death
Composite of major bleeding, recurrent stroke and/or vascular death (whichever occurs first)
Time frame: within one year after index stroke
Major bleeding, recurrent stroke and/or vascular death as single components
Each single component of the composite in outcome 2 (major bleeding, recurrent stroke and/or vascular death)
Time frame: within one year after index stroke
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100mg 1x/d
75mg 1x/d
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
RECRUITINGHospital Universitario Virgen Macarena
Seville, Spain
RECRUITINGCampus Hospital Universitario Virgen del Rocío
Seville, Spain
RECRUITINGKantonsspital Aarau, Department of Neurology
Aarau, Canton of Aargau, Switzerland
RECRUITINGUniversity Hospital of Basel
Basel, Switzerland
RECRUITINGUniversity Hospital of Bern/Inselspital
Bern, Switzerland
RECRUITINGOspedale Regionale di Lugano, Ente Ospedaliero Cantonale
Lugano, Switzerland
RECRUITINGKantonsspital St.Gallen
Sankt Gallen, Switzerland
RECRUITING...and 4 more locations