StrokeNet Trials at SPIRIT RCC Sites

ACTIVE (enrolling)

Laura Grenier, BA, BS, CRA, CCRC
email: laura.grenier@hhchealth.org

Betsy Moclair RN, CCRC
Email: bmoclair@norhwell.edu

Michael Kampp, CCRP
Email: michael.kampp@yale.edu

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

Open to enrollment: June 2019
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	Umran Ugur
Yale New Haven Hospital (Yale IRB HIC # 2000025466)	Henry Yaggi

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

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

Open to enrollment: approximately December 2019
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	Ana Albuja, Betty Vohr
Yale New Haven Hospital (Yale IRB: HIC# 2000025348)	Laura Ment

Open to enrollment: approximately March 2020
Overview: ASPIRE is a randomized, double-blinded, Phase III clinical trial designed to test the efficacy and safety of apixaban, compared with aspirin, in patients with a recent intracerebral hemorrhage (ICH) and high-risk non-valvular atrial fibrillation (AF). Seven hundred patients will be recruited at sites coordinated through the NIH/NINDS StrokeNET. Participants will be followed for outcomes over a median of 24 months (12 months minimum, 36 months maximum). Efficacy outcomes are stroke or death (primary) and change in modified Rankin Scale score (secondary). Tertiary outcomes include change in cognition and quality of life, major hemorrhage, myocardial infarction, venous thromboembolism, systemic embolism, and individual components of the primary outcome.

SPIRIT Site Hub	PI at Site
Hartford Hospital	Mark Alberts
North Shore University Hospital	Tania Rebeiz
Rhode Island Hospital	Michael Reznik
Yale New Haven Hospital (Yale IRB HIC# 200026409)	Guido Falcone

Open to enrollment
Overview: This is a multicenter, pragmatic, prospective, randomized, open-label, and blinded endpoint assessment (PROBE) clinical trial. A total of 1,456 patients presenting within seven days of a spontaneous lobar ICH while taking statins will be randomized to one of two treatment strategies: discontinuation vs. continuation (restarting) of statin therapy (using the same agent and dose that they were using at ICH onset). Randomization will take into account: clinical site, statin dose and indication (primary vs. secondary prevention), current use and intent-to-use oral anticoagulants (OAC) and/or antiplatelets in the long-term post-ICH, and severity of ICH upon presentation as assessed by baseline ICH volume. Participating subjects will undergo baseline testing for APOE genotype and will be followed for 24 months to assess for the occurrence of recurrent symptomatic ICH or MACCE during the follow-up period.

SITE	PI at Site
Hartford Hospital	Yan Hou
North Shore University Hospital	David LeDoux
Staten Island University Hospital	David Ledoux
South Shore University Hospital	Krista Lim-Hing
Rhode Island Hospital	Ali Mahta
Yale New Haven Hospital (Yale IRB HIC# 200027056)	Guido Falcone

Open to enrollment: September 2022
Overview: CAPTIVA is a two-stage Phase III trial randomizing subjects with stroke attributed to 70-99% intracranial atherosclerotic stenosis (sICAS) to 12 months treatment of:

ticagrelor (180 mg loading dose, then 90mg twice daily) + aspirin 81 mg / day, or…
low dose rivaroxaban (2.5mg twice daily) + aspirin 81 mg / day, or…
clopidogrel (600mg loading dose, then 75 mg daily) + aspirin 81 mg/day.
All subjects will also receive intensive risk factor management per the SAMMPRIS protocol and will undergo blinded genetic testing for CYP2C19 loss of carrier status. Subjects will be seen in person at 30 days, four months, eight months and at close out at 12 months. The primary goal of the trial is to determine if the experimental arm(s) (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the one-year rate of the primary endpoint (ischemic stroke, intracerebral hemorrhage (ICH), or vascular death).

Site	PI at Site
Hartford Hospital	Ajay Tunguturi
North Shore University Hospital	Rohan Arora
Rhode Island Hospital	Narendra Kala
Yale New Haven Hospital (Yale IRB HIC# 200031893)	Hardik Amin