Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2

Part of paid clinical trials in Birmingham, Alabama.

Sponsor: Joseph Broderick, MD
Study ID: NCT07227246
Phase: PHASE3
Status: Recruiting

Apply to this trial

Conditions

Intracerebral Hemorrhage

Eligibility Criteria

Sex: ALL
Age: 18 Years - 80 Years
Healthy Volunteers: Not accepted

Interventions

Recombinant Factor VIIa — BIOLOGICAL
Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. All participants in FASTEST Part 2 must have a positive spot sign on baseline CTA and be treated within 120 minutes of onset or patients treated within 90 minutes of stroke onset, with or without a positive spot sign. Participants in both arms will receive best standard therapy as per published AHA Guidelines for ICH, including a target systolic blood pressure of 140 mm Hg.
Biological/Vaccine: Placebo — BIOLOGICAL
Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. All participants in FASTEST Part 2 must have a positive spot sign on baseline CTA and be treated within 120 minutes of onset or patients treated within 90 minutes of stroke onset, with or without a positive spot sign. Participants in both arms will receive best standard therapy as per published AHA Guidelines for ICH, including a target systolic blood pressure of 140 mm Hg.

Study Details

The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 90 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. FASTEST Part 2 is an extension of the FASTEST Trial where the subgroups include those treated within 2 hours with a positive spot sign on a baseline CT angiogram or patients treated within 90 minutes of stroke onset, with or without a positive spot sign.

Key Dates

Start date: May 6, 2025
Status verified: May 2025
Primary completion: Jan 31, 2029
Completion: Jun 30, 2029

Study Design

Enrollment: 350 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Recombinant Factor VIIa
rFVIIa given as IV injection over 2 minutes within 120 minutes of stroke onset
Placebo Comparator: Placebo
Placebo given as IV injection over 2 minutes within 120 minutes of stroke onset

Primary Outcome Measure

Modified Rankin Scale [ Time Frame: 90 days ]

Central Contacts

Joseph P Broderick, MD
15139195404
[email protected]
James Grotta, MD
(281) 387-2329
[email protected]

Locations (48)

Facility	City	State	ZIP	Site coordinators
University of Alabama Hospital	Birmingham	Alabama	35233	Elizabeth Liptrap, MD [email protected]
Kaiser Permanente Baldwin Park Medical Center	Baldwin Park	California	91706	Navdeep Sangha, MD [email protected]
Mills Peninsula Medical Center	Burlingame	California	94010	Ilana Spokoyny, MD [email protected]
Kaiser Permanente Downey Medical Center	Downey	California	90242	Navdeep Sangha, MD [email protected]
Kaiser Permanente Fontana Medical Center	Fontana	California	92335	Navdeep Sangha, MD [email protected]
Kaiser Permanente South Bay Medical Center	Harbor City	California	90710	Navdeep Sangha, MD [email protected]
UCSD Health La Jolla	La Jolla	California	92037	Brett Meyer, MD [email protected]
Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	90027	Navdeep S Sangha, MD [email protected]
Kaiser Permanente West Los Angeles Medical Center	Los Angeles	California	90034	Navdeep Sangha, MD [email protected]
Ronald Reagan UCLA Medical Center	Los Angeles	California	90095	May Nour, MD, PhD [email protected]
UC Irvine Medical Center,	Orange	California	92868	Jay Shah, MD [email protected]
Kaiser Permanente Riverside Medical Center	Riverside	California	92505	Navdeep S Sangha, MD [email protected]
UC Davis Medical Center	Sacramento	California	95817	Lara L Zimmermann, MD [email protected]
UCSD Medical Center - Hillcrest Hospital	San Diego	California	92103	Brett Meyer, MD [email protected]
San Francisco General Hospital	San Francisco	California	94110	Vineeta Singh, MD [email protected]
UF Health Shands Hospital	Gainesville	Florida	32608	Anna Y Khanna, MD [email protected]
Mayo Clinic	Jacksonville	Florida	32224	Lauren K Ng, MD [email protected]
Grady Memorial Hospital	Atlanta	Georgia	30303	Digvijaya Navalkele, MD, MPH [email protected]
WellStar Kennestone Hospital	Marietta	Georgia	30060	Raisa C. Martinez, MD [email protected]
The Queen's Medical Center	Honolulu	Hawaii	96813	Chung-Huan Sun, MD [email protected]
Northwestern Memorial Hospital	Chicago	Illinois	60611	Babak S. Jahromi, MD, PhD [email protected]
University of Chicago Medical Center	Chicago	Illinois	60637	Ali Mansour, MD [email protected]
Central DuPage Hospital	Winfield	Illinois	60190	Harish N. Showkeen, MD [email protected]
Massachusetts General Hospital	Boston	Massachusetts	02114	Pierre Borczuk, MD [email protected]
UMass Memorial Medical Center	Worcester	Massachusetts	01605	Adalia H. Jun-O'Connell, MD [email protected]
Henry Ford Hospital	Detroit	Michigan	48208	Christopher A Lewandowski, MD [email protected]
M Health Fairview Ridges Hospital,	Burnsville	Minnesota	55337	Christopher Streib, MD [email protected]
M Health Fairview Southdale Hospital	Edina	Minnesota	55435	Christopher Streib, MD [email protected]
M Health Fairview St. John's Hospital	Maplewood	Minnesota	55109	Christopher Streib, MD [email protected]
M Health Fairview University of Minnesota Medical Center Hospital,	Minneapolis	Minnesota	55455	Christopher Streib, MD [email protected]
Mayo Clinic Saint Marys Campus	Rochester	Minnesota	55902	Eugene L. Scharf, M.D. [email protected]
Barnes Jewish Hospital	St Louis	Missouri	63110	Peter D Panagos, MD [email protected]
North Shore University Hospital	Manhasset	New York	11030	Richard Elias Temes, MD [email protected]
Mount Sinai West	New York	New York	10019	John W Liang, MD [email protected]
The Mount Sinai Hospital	New York	New York	10029	John Liang, MD [email protected]
Stony Brook University Hospital	Stony Brook	New York	11794	Jason Mathew, DO [email protected]
University of Cincinnati Medical Center	Cincinnati	Ohio	45229	Kyle Walsh, MD [email protected]
OSU Wexner Medical Center	Columbus	Ohio	43210	Yousef Hannawi, MD [email protected]
Riverside Methodist Hospital	Columbus	Ohio	43214	William J Hicks, MD [email protected]
St. John Medical Center	Tulsa	Oklahoma	74104	Errol L Gordon, MD [email protected]
Providence St. Vincent Medical Center	Portland	Oregon	97225	Ted J Lowenkopf, MD [email protected]
Temple University Hospital	Philadelphia	Pennsylvania	19140	Nina T Gentile, MD [email protected]
Medical University of South Carolina University Hospital	Charleston	South Carolina	29425	Christine Holmstedt, MD [email protected]
Prisma Health Greenville Memorial Hospital	Greenville	South Carolina	29605	Sanjeev Sivakumar, MD [email protected]
Memorial Hermann Memorial City Medical Center	Houston	Texas	77024	Ritvij Bowry, MD [email protected]
Memorial Hermann-Texas Medical Center	Houston	Texas	77030	James Grotta, MD [email protected]
University of Utah Healthcare	Salt Lake City	Utah	84132	Ramesh Grandhi, MD, MS [email protected]
VCU Medical Center	Richmond	Virginia	23219	Dennis J. Rivet, MD [email protected]

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University of Alabama Hospital· Birmingham, AL Kaiser Permanente Baldwin Park Medical Center· Baldwin Park, CA Mills Peninsula Medical Center· Burlingame, CA Kaiser Permanente Downey Medical Center· Downey, CA Kaiser Permanente Fontana Medical Center· Fontana, CA Kaiser Permanente South Bay Medical Center· Harbor City, CA

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