AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
Objectives
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 up to 200 sites in and out of the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 7 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:
Age ≥ 45 years.
Clinical diagnosis of ischemic stroke + brain imaging to rule out hemorrhagic stroke.
Modified Rankin Scale (MRS) score ≤ 4.
Ability to be randomized within 3 to 180 days after stroke onset.
ESUS, defined as all of the following:
Exclusion Criteria:
To be eligible for randomization, consented participants must meet criteria for atrial cardiopathy in addition to the inclusion/exclusion criteria above.
Atrial cardiopathy is defined as ≥1 of the following:
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