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FVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial

Award Number: U01NS110772
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/01/2020
PERIOD OF PERFORMANCE END DATE: 12/31/2026

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FVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial - Project Summary Recombinant Factor VIIa (rFVIIa) for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is a randomized, double-blind, controlled global trial of rFVIIa plus best standard therapy vs. best standard therapy alone for patients with intracerebral hemorrhage (ICH). Our central hypothesis is that treatment with rFVIIa within two hours of onset in appropriately selected patients with spontaneous ICH improves outcome as measured by the ordinal distribution of the modified Rankin Scale (mRS) at 90 days, as compared to placebo. We will test our hypothesis in 860 patients recruited at 100 hospital sites and at least 15 mobile stroke units (MSUs) within the NINDS StrokeNet (70 sites) and key global institutions (30 sites) with large volumes of patients with ICH and ability to treat within 2 hours of onset. Participating countries include the U.S., Canada, United Kingdom, Germany, Spain, Japan, and Australia. We will include subjects with a volume of ICH < 60 cc, no intraventricular hemorrhage (IVH) or a small volume of IVH (IVH score ≤ 7), age ≤ 80, GCS ≥ 8, and treated within 120 minutes from last known normal. To minimize time-to-treatment, the study will use exception from informed consent and MSUs with a goal of ½ of patients treated within 90 minutes as accomplished in the NINDS t-PA trials. We will recruit the 860 patients over 3 1/2 years and randomize them in a double-blinded fashion to rFVIIa 80 micrograms/kg dose (maximum 8mg dose) or placebo. Subjects in both arms will receive best medical therapy as per published AHA Guidelines for ICH, including a target blood pressure of 140 mm Hg. The primary efficacy outcome measure is the ordinal distribution of the mRS at 90 days. Primary safety outcomes will include ischemic events (cerebral infarction, myocardial infarction, and pulmonary embolus) within 4 days of study medication. To measure growth of ICH and IVH, all subjects will have baseline non- contrast CT and at 24 hours. Centralized volumetric measurements of ICH, IVH, and edema will be done for both time-points. The overall principal investigators (PIs) for the Trial include Joseph Broderick, James Grotta, Andrew Naidech, and Jordan Elm (primary statistical PI) as well as PIs for each participating non-U.S. country. In summary, the goal of FAST is to find the first scientifically proven treatment for acute ICH.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $3,387,873 )
2026	2026	CINCINNATI UNIV OF	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	5	2/27/2026	SUPPLEMENT FOR EXPANSION	$389,840
2026	2026	CINCINNATI UNIV OF	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	004	5	3/5/2026	SUPPLEMENT FOR EXPANSION	$50,000
2026	2026	CINCINNATI UNIV OF	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	5	2/25/2026	NON-COMPETING CONTINUATION	$287,576
2026	2026	CINCINNATI UNIV OF	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	2/2/2026	NON-COMPETING CONTINUATION	$2,588,182
2026	2026	CINCINNATI UNIV OF	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	5	2/28/2026	SUPPLEMENT FOR EXPANSION	$72,275
														Subtotal = $3,387,873

Issue Date FY: 2025 ( Subtotal = $4,412,639 )
2025	2025	CINCINNATI UNIV OF	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	4	2/17/2025	NON-COMPETING CONTINUATION	$4,412,639
2025	2024	CINCINNATI UNIV OF	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	12/3/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $4,412,639

Issue Date FY: 2024 ( Subtotal = $4,884,159 )
2024	2024	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	3	4/25/2024	NON-COMPETING CONTINUATION	$348,373
2024	2024	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	3	2/29/2024	SUPPLEMENT FOR EXPANSION	$56,700
2024	2024	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	3	1/24/2024	NON-COMPETING CONTINUATION	$4,479,086
2024	2021	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	11/2/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $4,884,159

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	2	6/26/2023	NON-COMPETING CONTINUATION	$0
2023	2021	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	3/20/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	3/11/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $5,130,446 )
2021	2021	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	1/12/2021	NON-COMPETING CONTINUATION	$5,130,446
														Subtotal = $5,130,446

Issue Date FY: 2020 ( Subtotal = $6,472,265 )
2020	2020	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	2/28/2020	NEW	$6,472,265
														Subtotal = $6,472,265

Grand Total All Awards = $24,287,382

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FVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial

Award Number: U01NS110772

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/01/2020

PERIOD OF PERFORMANCE END DATE: 12/31/2026

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