Search

Introduction: Cognitive decline and dementia after stroke is a major public healthcare problem, with dementia risk doubling over time, affecting more than 2M people in the US, with no current treatment. Silent brain infarction has been associated with cognitive decline, especially among those at risk for cardio-embolism. The therapeutic challenge is to prevent the occurrence of silent infarction to mitigate proactively the loss of cognitive function. Methods: The NINDS-funded ARCADIA-CSI is an ancillary study to ARCADIA, a randomized trial comparing apixaban vs aspirin to prevent recurrent clinical stroke in patients with cryptogenic stroke and left atrial cardiopathy. The aim of ARCADIA-CSI is to address whether apixaban might also reduce the incidence of silent infarction and be associated with better cognitive function over time compared to aspirin. Five hundred patients will be enrolled at least 90 days after the ARCADIA index stroke and undergo cognitive assessments at baseline and yearly thereafter using a telephone-based cognitive battery. We are testing the hypothesis that the slope of change in cognitive function is less steep during the follow-up period in patients on apixaban compared to patients on aspirin therapy. We will also collect an initial MRI around the time of the qualifying stroke and a follow-up MRI at the time that the subject completes participation in the ARCADIA parent study to assess the occurrence of new silent infarction. Results: As of August 12, 2021, the study has enrolled 188 subjects from 78 ARCADIA sites which have been green-lighted for enrollment in ARCADIA-CSI. A total of 61 sites have enrolled at least one subject. To date, there is a 95% completion of baseline cognitive exams and 98% completion at the 1-yr follow-up. We have obtained 91% of the clinical scans of the index stroke of which 95% have undergone central reading and interpretation. Conclusion: ARCADIA-CSI is designed to identify the most favorable medical approach to prevent the occurrence of silent infarction and cognitive decline in the setting of secondary stroke prevention. An update will be provided regarding the number of patients enrolled, centers green-lighted, and the completion rates of cognitive assessments, and MRIs obtained and interpreted.