Study for People with Unexplained Strokes and Atrial Cardiopathy
Protocol: SITE00000005
Full Title
AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke
Description
The purpose of this research study is to compare the use of apixaban to aspirin in patients with unexplained strokes and atrial cardiopathy to see which is better at prevention of future strokes.
You will be in the research study for a minimum of 18 months and a maximum of 48 months (depending on when you start) or until the study ends (approximately 4 years). During the study you will be randomly selected (like the flip of a coin) to take one of two study drug regimens. You will have at least 6 in-person study visits and follow ups via phone as well. Study visits take place at UB Neurology 1010 Main Street, Buffalo, NY 14202.
Compensation is not available.

Technical Description

(CSR # 180239623095) 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. Primary objective is to test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. The secondary objective is to test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.
Compensation: No
Eligibility
Adults ages 45+
Have been diagnosed with an ischemic stroke of undetermined cause in the last 120 days.
Currently admitted to Gates Vascular Institute.
Age Group: Adults
Principal Investigator: ROBERT SAWYER
ClinicalTrials.gov: Open Study
Contact(s)
ANNEMARIE CRUMLISH
ac35@buffalo.edu
+1 716-859-7540
Want to Learn More?
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.