Closed SPIRIT StrokeNet Trials
ARCADIA
- Enrollment period: November 2018 to December 2022
- 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
- Enrollment period: May 2019 to December 2022
- 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 |
CREST-2
- Enrollment period: March 2015 to July 2024
- Overview: The purpose of this Long-Term Observational Extension of Participants in the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis (CREST-2) Randomized Clinical Trial study is to study is to assess post-procedural efficacy of carotid endarterectomy and carotid stenting.
| SITE | PI at Site |
|---|---|
| Hartford Hospital | Parth S. Shah |
| North Shore University Hospital/Feinstein | Henry Woo |
| Miriam Hospital | Peter Soukas (co-PI), Robert Patterson (co-PI) |
| Yale New Haven Hospital (Yale IRB HIC# #1501015248) | Carlos Mena |
CREST-H
- Enrollment period: 2018 to July 2024
- Overview: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis – Hemodynamics (CREST-H). A blockage in the carotid arteries can lower blood flow to the brain, which may affect memory or thinking in some people. This condition may be treatable, either with medicine or with a stent or endarterectomy.
- CREST-H, is a companion study to CREST-2. Those who are randomized into CREST-2 will be asked if they would like to participate in CREST-H as well. CREST-H participants will receive an MRI or CT scan of the brain’s blood flow free of charge.
| SITE | PI at Site |
|---|---|
| Hartford Hospital | Parth S. Shah |
| Miriam Hospital | Gaurav Jindal |
| Yale New Haven Hospital (Yale IRB HIC# #2000032392) | Carlos Mena |
MOST
- Enrollment period: May 2019 to July 2023
- 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 |
I-ACQUIRE
I-Acquire Logo
- Enrollment period: May 2019 to October 2024
- Overview: This is a phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS). Ages eligible for study: 8-36 months
| SPIRIT Site Hub | PI at Site |
|---|---|
| Rhode Island Hospital, Women & Infants Hospital | Anna Albuja, Betty Vohr |
| Yale New Haven Hospital (Yale IRB: HIC# 2000025348) | Laura Ment |
Sleep SMART
- Enrollment period: June 2019 to December 2025
- Overview: Investigator-initiated, Phase III multicenter, prospective randomized open-, blinded-endpoint (PROBE) controlled trial to test whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure is effective for secondary prevention and recovery after stroke.
| SPIRIT Site Hub | PI at Site |
|---|---|
| Hartford Hospital | Francoise Roux |
| North Shore University Hospital | Rohan Arora |
| Staten Island University Hospital (Closed to enrollment) | Umran Ugur |
| Yale New Haven Hospital (Yale IRB HIC # 2000025466) | Henry Yaggi |