Closed SPIRIT StrokeNet Trials
ARCADIA
- Opened to enrollment since November 2018
- Overview: ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, Phase III 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 at up to 200 sites in the NIH StrokeNET consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of four 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.
| SPIRIT Site Hub | PI at Site |
|---|---|
| Hartford Hospital | Yan Hou |
| St. Vincent's Medical Center | Kelly Matmati |
| North Shore University Hospital | Jeffrey Katz |
| Lenox Hill Hospital | Salman Azhar |
| Rhode Island Hospital | Tina Burton |
| Yale New Haven Hospital (Yale IRB HIC# 2000024124) | Reshma Narula |
ARCADIA-CSI
- Open to enrollment: approximately November 2019
- Overview: Patients randomized in ARCADIA will be eligible for ARCADIA-CSI if they can undergo cognitive testing (English speakers with score <2 on the NIHSS language item) and have no MRI contraindications. Of the 1,100 patients who will be randomized in ARCADIA, we will enroll 500 in ARCADIA-CSI. ARCADIA-CSI subjects will undergo their routine ARCADIA study visits plus: 1) baseline and annual neuropsychological testing; 2) a MRI brain scan at enrollment if not already obtained as part of routine care; and 3) a MRI at their final ARCADIA study visit.
| SPIRIT Site Hub | PI at Site |
|---|---|
| Hartford Hospital | Yan Hou |
| North Shore University Hospital | Jeffrey Katz |
| Rhode Island Hospital | Tina Burton |
| Yale New Haven Hospital (Yale IRB HIC# 200026199) | Reshma Narula |
MOST
- Open to enrollment: approximately November 2019
- Overview: The primary efficacy objective of the MOST trial is to determine if argatroban (100μg/kg bolus followed by 3μg/kg per minute for 12 hours) or eptifibatide (135μg/kg bolus followed by 0.75μg/kg/min infusion for two hours) results in improved 90-day modified Rankin scores (mRS) as compared with placebo in acute ischemic stroke (AIS) patients treated with 0.9mg/kg IV rt-PA within three hours of symptom onset.
| SPIRIT Site Hub | PI at Site |
|---|---|
| North Shore University Hospital | Rohan Arora |
| Yale New Haven Hospital (Yale IRB HIC# 2000024503) | Adam Jasne |