Redefining Stroke and Neurological Care
As one of the nation’s elite teaching hospitals, our neurology clinicians are involved in studies aimed at finding better, more effective ways to care for neurology patients. Research conducted at Grady is helping to redefine the way doctors around the world treat stroke and neurological conditions. This commitment to research means that Grady offers the best standard stroke and neurological care – and the best emerging care. The benefit to patients is clear: They have access to treatment options unavailable at most other institutions.
FASTEST/ Navalkele, PI
FASTEST is a multicenter research study involving patients who have had bleeding in the brain, also called intracerebral hemorrhage (ICH). ICH occurs when a weakened blood vessel in the brain breaks and bleeding accumulates in the brain. Most of this bleeding occurs within a few hours of onset of symptoms. The brain injury from ICH is usually very severe, over 40% of people with ICH die within a month, and only 20% can independently care for themselves after 6 months. There is currently no treatment for ICH that is scientifically proven to improve outcome. The FASTEST research study is being done to determine if recombinant Factor VIIa (rFVIIa), a protein that our body makes to stop bleeding at the site of injury to a blood vessel, can slow bleeding in the brain and improve outcome. rFVIIa is approved for treatment of bleeding in patients who have inherited lack of clotting factors but is not approved for treatment of ICH. For more information, visit https://nihstrokenet.org/fastest/home
ESCAPE NA-1 / Nogueira, PI
A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Singledose Design to Determine the Efficacy and Safety of Intravenous NA-1 in Subjects with Acute Ischemic Stroke Undergoing Endovascular Thrombectomy (ESCAPE-NA1 Trial): This study is a Phase 3, randomized, multicenter, blinded, placebo controlled, parallel group, single-dose design. Subjects having an acute ischemic stroke and who are selected for endovascular revascularization and who have a small established infarct core and with good collateral circulation are will be given a single intravenous dose of NA-1 or placebo as soon as they are deemed to have met the enrollment criteria.
EXCELLENT (Embotrap device registry) / Haussen, PI
Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy: The objective of this global, multi-site study is to assess the efficacy of the EmboTrap® Revascularization Device in a real-world setting, and to explore correlations between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes.
Arcadia / Bianchi, PI
AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke: 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.
CHARM (IV Glyburide massive cerebral edema) / Ratcliff, PI
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction: CHARM is a 2-part Phase 3 study to assess efficacy and safety of intravenous (IV) BIIB093 to improve functional outcomes in subjects with large hemispheric infarction. Part 1 is a 90-day efficacy and safety evaluable period following a 72-hour infusion of BIIB093 or matching placebo, and Part 2 is a follow-up period with study visits at Month 6 and Month 12.
Novartis (BAF312 Siponimod) ICH / Ratcliff, PI
A phase II, patient- and investigator-blinded, randomized, placebo-controlled study to evaluate efficacy, safety and tolerability of BAF312 (siponimod) in patients with stroke due to intracerebral hemorrhage (ICH): The purpose of the study is to investigate the initial efficacy and safety of BAF312 administered on top of standard-of-care compared to placebo in patients with stroke due to ICH; and to determine if the overall clinical profile of BAF312 warrants further clinical development in ICH.
VIGOR (Volumetric Impedance to Guide Stroke Response) / Nogueira
The purpose of this two-part study is to assess the ability of the Cerebrotech Visor System (CVS) to detect hemispheric bioimpedance asymmetry associated with severe stroke in patients presenting for the evaluation of acute stroke. The device is noninvasive, minimal risk. No diagnostic or therapeutic decisions will be informed by the investigational device.
Current Stem Cell Trials
Cobis 2 / Belagaje, PI
Phase 2 Study of Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke – CoBIS 2: This is a multicenter, placebo-controlled, randomized, double‑blinded Phase 2 study in 100 subjects 18-90 years of age who have sustained a recent ischemic stroke. Treatment with umbilical cord blood (UCB) cells or placebo will be administered intravenously as a single infusion as early as 3 days but no later than 10 days after the patient’s stroke. Administration of UCB cells or placebo diluent will only be done after confirmation of eligibility criteria. UCB units will be selected from an accredited U.S. public cord bank based on blood type. Study patients will not receive immunosuppressive or myeloablative medications prior to infusion of the cord blood or placebo. For more information, visit https://nihstrokenet.org/fastest/home
PISCES (A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells(CTX0E03) in Subjects with Disability Following an Ischemic Stroke) / Belagaje, PI
A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells (CTX0E03) in Subjects with Disability following an Ischemic Stroke (PISCES III): Following confirmation of eligibility criteria, subjects will be randomized in 1:1 ratio to receive either a single administration of CTX0E03 DP by intracerebral implantation or receive placebo surgery only.
Pivotal Clinical Trials
DWI or CTP Assessment With Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention With Trevo.
The purpose of this study was to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days, as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.
The DAWN trial showed that, among patients with acute ischemic stroke presenting 6-24 hours after symptom onset due to proximal large arterial occlusion, and with evidence of a mismatch between infarct volume on imaging and severity of clinical deficits, endovascular thrombectomy along with standard of care was superior to routine standard of care for outcomes of disability and functional independence at 90 days.
Grady was the second highest enrolling site internationally and was recognized as having the least number of protocol deviations study-wide.
A Double-Blind, Controlled Phase 2b Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Ischemic Stroke.
*Pending results of trial (anticipated Summer 2019)
Solitaire™ FR with the intention for thrombectomy as primary endovascular treatment for acute ischemic stroke.
The study was stopped early because of efficacy. The SWIFT-PRIME trial showed that in patients receiving intravenous t-PA for acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, thrombectomy with a stent retriever within 6 hours after onset improved functional outcomes at 90 days.
Research At Grady
If you are interested in performing research at Grady, find out how to begin by visiting our Office of Research Administration.