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ARCADIA


Title AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke
Therapeutic Area Stroke
Principal Investigator Emiliya Melkumova, MD
Min Age 45 Years
Gender All
Contact Keri Sullivan
617 636-7620
More Information https://clinicaltrials.gov/ct2/show/NCT03192215

Overview

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.

Study Details

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.