ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NIH StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.
Inclusion Criteria
- Clinical diagnosis of ischemic stroke+ brain imaging to rule out hemorrhagic stroke
- Stroke etiology determined as unknown cause (i.e. “Embolic Stroke of Undetermined Source”)
Exclusion Criteria
- History of Atrial Fibrillation
- Clear indication for anti-coagulation
- Known allergy or intolerance to aspirin or apixaban
Study Requirements
Following the episode of stroke and determination of eligibility, subjects can enroll and begin the screening process which involves standard of care follow-up testing, as well as a singular blood sample to be sent off to a central lab. After determination of atrial cardiopathy (i.e. confirmation of one of three criteria: including the blood sample, a heart image, and an EKG), the subject will be randomized to apixaban and aspirin placebo or aspirin and apixaban placebo. Clinic follow-up occurs every six months for the first year, and annually for the following three years.
