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.