Recombinant Factor VIIa for Hemorrhagic Stroke Treatment at Earliest Possible Time (FASTEST): Protocol for a Phase III, Double-Blind, Randomized, Placebo-Controlled Trial

Authors

Andrew M. Naidech, Northwestern Medicine, Chicago, IL, USA.
James Grotta, University of Texas at Houston, TX, USA.
Jordan Elm, Medical University of South Carolina, Charleston, SC, USA.
Scott Janis, National Institute of Neurological Diseases and Stroke, Bethesda, MD, USA.
Dar Dowlatshahi, University of Ottawa, Ottawa, Canada.
Kazunori Toyoda, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
Thorsten Steiner, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
Stephan A. Mayer, New York Medical College, Valhalla, NY, USA.
Pooja Khanolkar, University of Cincinnati, OH, USA.
Julie Denlinger, University of Cincinnati, OH, USA.
Heinrich J. Audebert, Charité University Hospital, Berlin, Germany.
Carlos Molina, Hospital Vall d'Hebron, Barcelona, Spain.
Pooja Khatri, University of Cincinnati, OH, USA.
Nikola Sprigg, University of Nottingham, Nottingham, UK.
Achala Vagal, University of Cincinnati, OH, USA.
Joseph P. Broderick, University of Cincinnati, OH, USA.

Author Type(s)

Faculty

Journal Title

International Journal of Stroke

First Page

806

Last Page

809

Document Type

Article

Publication Date

8-1-2022

Department

Neurology

Abstract

INTRODUCTION: Intracerebral hemorrhage is the deadliest form of stroke. Hematoma expansion, growth of the hematoma between the baseline computed tomography scan and a follow-up computed tomography scan at 24 ± 6 h, predicts long-term disability or death. Recombinant factor VIIa (rFVIIa) has reduced hematoma expansion in previous clinical trials with a variable effect on clinical outcomes, with the greatest impact on hematoma expansion and potential benefit when administered within 2 h of symptom onset. METHODS: Factor VIIa for Hemorrhagic Stroke Treatment at Earliest Possible Time (FASTEST, NCT03496883) is a randomized controlled trial that will enroll 860 patients at ∼100 emergency departments and mobile stroke units in five countries. Patients are eligible for enrollment if they have acute intracerebral hemorrhage within 2 h of symptom onset confirmed by computed tomography, a hematoma volume of 2 to 60 mL, no or small volumes of intraventricular hemorrhage, do not take anticoagulant medications or concurrent heparin/heparinoids (antiplatelet medications are permissible), and are not deeply comatose. Enrolled patients will receive rFVIIa 80 µg/kg or placebo intravenously over 2 min. The primary outcome measure is the distribution of the ordinal modified Rankin Scale at 180 days. FASTEST is monitored by a Data Safety Monitoring Board. Safety endpoints include thrombotic events (e.g. myocardial infarction). Human subjects research is monitored by an external Institutional Review Board in participating countries. DISCUSSION: In the US, FASTEST will be first NIH StrokeNet Trial with an Exception from Informed Consent which allows enrollment of non-communicative patients without an immediately identifiable proxy.

Recommended Citation

Naidech, A. M., Grotta, J., Elm, J., Janis, S., Dowlatshahi, D., Toyoda, K., Steiner, T., Mayer, S. A., Khanolkar, P., Denlinger, J., Audebert, H. J., Molina, C., Khatri, P., Sprigg, N., Vagal, A., & Broderick, J. P. (2022). Recombinant Factor VIIa for Hemorrhagic Stroke Treatment at Earliest Possible Time (FASTEST): Protocol for a Phase III, Double-Blind, Randomized, Placebo-Controlled Trial. International Journal of Stroke, 17 (7), 806-809. https://doi.org/10.1177/17474930211042700