Abstract Number: Esoc2026ot107 Recombinant Factor Viia (rfviia) for Acute Hemorrhagic Stroke Administered at Earliest Time (fastest) Trial
Year: 2026
Type: conference-abstract
Abstract: Background and aims The FASTEST trial was designed to evaluate whether ultra-early administration of recombinant activated factor VII (rFVIIa) in an enriched subgroup, can improve outcomes in spontaneous intracerebral hemorrhage (ICH). Methods To determine whether rFVIIa administered within 120 minutes of symptom onset slows growth at 24 hours and improves functional outcomes at 180 days as measured by the modified Rankin Scale in patients with ICH. Results FASTEST is a phase III, international, randomized, adaptive, double-blind, placebo-controlled trial comparing rFVIIa (80 μg/kg; maximum dose 10 mg) plus best standard therapy versus placebo plus best standard therapy. In FASTEST Part 1, eligible participants were aged 18–80 years, had spontaneous ICH with a volume ≥2 cc and <60 cc, a Glasgow Coma Scale score ≥8, limited intraventricular hemorrhage, and could be treated within 120 minutes of stroke onset. Imaging included baseline and 24-hour non-contrast CT scans of the head and CT angiography (CTA) when done as standard of care. A neuroradiologist centrally assessed volume of ICH and intraventricular hemorrhage (IVH), and the presence of spot sign on CTA. Conclusions FASTEST Part 1 was stopped for futility overall in January 2025 after enrollment of 626 participants. Based upon data from FASTEST Part 1, FASTEST Part 2 began in May 2025 with the same entry criteria as Part 1, but patients must have a spot sign on CTA if treated within 120 minutes or be treated within 90 minutes. Conflict of interest
Source: European Stroke Journal
Authors: Joseph Broderick, James Grotta, Andrew M Naidech, Jordan Elm, Kazunori Toyoda, Dar Dowlatshahi, Thorsten Steiner, Philip Bath, Carlos Molina, Andrew Demchuk, Heinrich Audebert, J Mocco, Pooja Khatri, Achala Vagal, Lily Wang, Stephan A Mayer, Sohei Yoshimura, Richard Aviv, Emily Stinson, Fastest Investigators
Institutions: University of Cincinnati, Memorial Hermann, Texas Medical Center, Memorial Hermann–Texas Medical Center, Northwestern University, Medical University of South Carolina, National Cerebral and Cardiovascular Center, University of Ottawa, Klinikum Frankfurt Höchst, University of Nottingham, Queen's Medical Centre, Universitat Autònoma de Barcelona, Vall d'Hebron Hospital Universitari, University of Calgary, Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, NewYork–Presbyterian Hospital, Weill Cornell Medicine, Yale University, New York Medical College, Ottawa Hospital
Language: English
Subfield: Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,400
OpenAlex ID: W7160435609
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