StrokeNet Trials at SPIRIT RCC Sites

Hub Contacts:

Hartford Healthcare Primary Coordinator

• Hartford Hospital
• St. Vincent’s Medical Center
  

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

Northwell Health Research Manager

• North Shore University Hospital
• Lenox Hill Hospital
• Staten Island University Hospital
• South Shore University Hospital

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

Rhode Island Hospital Research Manager

Ashley Schomer
email: Ashley.Schomer@lifespan.org

Yale New Haven Hospital Primary Coordinator/Research Manager

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

• 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.

• Closed 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

• 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.

• 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.

• 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.

• 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.

• 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:

1. ticagrelor (180 mg loading dose, then 90mg twice daily) + aspirin 81 mg / day, or…
2. low dose rivaroxaban (2.5mg twice daily) + aspirin 81 mg / day, or…
3. clopidogrel (600mg loading dose, then 75 mg daily) + aspirin 81 mg/day.
4. 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).

• Open to enrollment
• Overview: CAPTIVA-MRI is an observational multimodal magnetic resonance imaging (MRI) that is ancillary to the CAPTIVA trial, a Phase III trial also being conducted at StrokeNet. The primary goal of this ancillary study is to evaluate advanced MRI biomarkers for identifying intracranial atherosclerosis patients who may not respond optimally to medical management.

• Open to enrollment December 2023
• Overview: The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial, a multi-centered, randomized, Phase 3 research study, is to learn if the experimental drug recombinant Factor VIIa (rFVIIA), a protein that our body makes, can be used to decrease bleeding in the brain of patients who suffer sudden bleeding in the brain, also called intracerebral hemorrhage (ICH). The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of participants most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.

• Open to enrollment – Open to Enrollment
• Overview: Strategy for Improving Stroke Treatment Response (SISTER) is a phase-2, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23. TS23 is a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke. The study will be conducted at up to 50 U.S. sites and enroll a total of 300 adults (>18 years) with acute ischemic stroke who have a baseline NIHSS >6 and are able to receive study drug within 4.5-24 hours after stroke onset (or last known well) who have evidence of core-penumbra mismatch on baseline perfusion imaging and are not planned for endovascular intervention or standard of care intravenous (IV) thrombolysis. SISTER’s primary objective is to identify a dose of TS23 that is safe and more efficacious than placebo for the treatment of patients from 4.5 to 24 hours of ischemic stroke onset (or last known well), who have evidence of core-penumbra mismatch on perfusion imaging and are not a candidate for standard of care reperfusion therapies.

• Pending Start up
• Overview: The overarching objective of the StrokeNet Thrombectomy Endovascular Platform (STEP) trial is to determine the optimal treatment strategies for patients with acute ischemic stroke due to large or medium vessel occlusions who are potentially amenable to endovascular therapy.
• Different treatments options considered will be improved devices, techniques, adjuvant therapies, and systems of care. As these different treatment options are identified to be tested, they will be added as domains through a Master Protocol. The Master Protocol describes trial procedures, data collection, data monitoring, follow-up visits, and safety procedures that will be employed in all Domain-Specific Appendices.
• The first STEP domain will test endovascular treatment vs medical management for the following groups of patients: 1)large vessel occlusion and low NIHSS and 2) Distal/medium vessel occlusion.