Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial

Who is this study for? Patients with Intracerebral Hemorrhage
What treatments are being studied? Recombinant Activated Factor VII (rFVIIa)
Status: Recruiting
Location: See all (88) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients aged 18-80 years, inclusive

• Patients with spontaneous ICH

• Able to treat with study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well

• Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, U.K., Japan)

Locations
United States
Alabama
University of Alabama Hospital
RECRUITING
Birmingham
Arizona
St. Joseph's Hospital and Medical Center
RECRUITING
Phoenix
California
Kaiser Permanente Baldwin Park Medical Center
RECRUITING
Baldwin Park
Mills Peninsula Medical Center
RECRUITING
Burlingame
Kaiser Permanente Downey Medical Center
RECRUITING
Downey
Kaiser Permanente Fontana Medical Center
RECRUITING
Fontana
Kaiser Permanente South Bay Medical Center
RECRUITING
Harbor City
UCSD Health La Jolla
RECRUITING
La Jolla
Kaiser Permanente Los Angeles Medical Center
RECRUITING
Los Angeles
Kaiser Permanente West Los Angeles Medical Center
RECRUITING
Los Angeles
Ronald Reagan UCLA Medical Center
RECRUITING
Los Angeles
UC Irvine Medical Center,
RECRUITING
Orange
Kaiser Permanente Riverside Medical Center
RECRUITING
Riverside
UC Davis Medical Center
RECRUITING
Sacramento
UCSD Medical Center - Hillcrest Hospital
RECRUITING
San Diego
San Francisco General Hospital
RECRUITING
San Francisco
Florida
UF Health Shands Hospital
RECRUITING
Gainesville
Mayo Clinic
RECRUITING
Jacksonville
Georgia
Grady Memorial Hospital
RECRUITING
Atlanta
WellStar Kennestone Hospital
RECRUITING
Marietta
Hawaii
The Queen's Medical Center
RECRUITING
Honolulu
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
University of Chicago Medical Center
RECRUITING
Chicago
Central DuPage Hospital
RECRUITING
Winfield
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
UMass Memorial Medical Center
RECRUITING
Worcester
Michigan
Henry Ford Hospital
RECRUITING
Detroit
Minnesota
M Health Fairview Ridges Hospital,
RECRUITING
Burnsville
M Health Fairview Southdale Hospital
RECRUITING
Edina
M Health Fairview St. John's Hospital
RECRUITING
Maplewood
M Health Fairview University of Minnesota Medical Center Hospital,
RECRUITING
Minneapolis
Mayo Clinic Saint Marys Campus
RECRUITING
Rochester
Missouri
Barnes Jewish Hospital
RECRUITING
St Louis
North Carolina
Wake Forest Baptist Medical Center
RECRUITING
Winston-salem
New York
North Shore University Hospital
RECRUITING
Manhasset
Mount Sinai West
RECRUITING
New York
The Mount Sinai Hospital
RECRUITING
New York
Stony Brook University Hospital
RECRUITING
Stony Brook
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
OSU Wexner Medical Center
RECRUITING
Columbus
Riverside Methodist Hospital
RECRUITING
Columbus
Toledo Hospital
RECRUITING
Toledo
Oklahoma
St. John Medical Center
RECRUITING
Tulsa
Oregon
Providence St. Vincent Medical Center
RECRUITING
Portland
Pennsylvania
Temple University Hospital
RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina University Hospital
RECRUITING
Charleston
Prisma Health Greenville Memorial Hospital
RECRUITING
Greenville
Texas
Memorial Hermann Memorial City Medical Center
RECRUITING
Houston
Memorial Hermann-Texas Medical Center
RECRUITING
Houston
Utah
University of Utah Healthcare
RECRUITING
Salt Lake City
Virginia
VCU Medical Center
RECRUITING
Richmond
Other Locations
Canada
University of Calgary - Foothills Medical Centre
RECRUITING
Calgary
University of Alberta Hospital
RECRUITING
Edmonton
Hamilton General Hospital
RECRUITING
Hamilton
University of Montreal Hospital
RECRUITING
Montreal
Ottawa Hospital Research Institute
RECRUITING
Ottawa
St. Michaels Hospital
RECRUITING
Toronto
Sunnybrook Health Sciences Center
RECRUITING
Toronto
Vancouver General Hospital
RECRUITING
Vancouver
Germany
University Hospital Augsburg
RECRUITING
Augsburg
Charite University Medicine Berlin
RECRUITING
Berlin
Clinic Frankfurt Hoechst
RECRUITING
Frankfurt Am Main
University Hospital Heidelberg
RECRUITING
Heidelberg
University Hospital Tuebingen
RECRUITING
Tübingen
Japan
Kyushu Medical Center
RECRUITING
Fukuoka
Gifu University Hospital
RECRUITING
Gifu
Kagoshima City Hospital
RECRUITING
Kagoshima
Kobe City Medical Center General Hospital
RECRUITING
Kobe
Japanese Red Cross Kyoto Daini Hospital
RECRUITING
Kyoto
Iwate Prefectural Central Hospital
RECRUITING
Morioka
Niigata City General Hospital
RECRUITING
Niigata
KMU University Hospital
RECRUITING
Osaka
NHO Osaka National Hospital
RECRUITING
Osaka
Nakamura Memorial Hospital
RECRUITING
Sapporo
Jichi Medical University Hospital
RECRUITING
Shimotsuke
National Cerebral and Cardiovascular Center
RECRUITING
Suita
Kyorin University Hospital
RECRUITING
Tokyo
Toranomon Hospital
RECRUITING
Tokyo
Spain
Hospital Universitari Germans Trias i Pujol
RECRUITING
Badalona
Santa Creu and Sant Pau Hospital
RECRUITING
Barcelona
Girona University Hospital
RECRUITING
Girona
Vall d'Hebron University Hospital (VHUH)
RECRUITING
Horta
Bellvitge University Hospital,
RECRUITING
L'hospitalet De Llobregat
Arnau de Vilanova University Hospital
RECRUITING
Lleida
United Kingdom
Royal Victoria Infirmary
RECRUITING
Newcastle Upon Tyne
Queens Medical Centre
RECRUITING
Nottingham
John Radcliffe Hospital
RECRUITING
Oxford
Royal Stoke University Hospital
RECRUITING
Stoke-on-trent
Contact Information
Primary
Joseph Broderick, MD
joseph.broderick@uc.edu
(513) 919-5404
Backup
James Grotta, MD
james.c.grotta@uth.tmc.edu
(281) 387-2329
Time Frame
Start Date: 2021-12-03
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 860
Treatments
Active_comparator: Recombinant Activated Factor VII (rFVIIa)
rFVIIa given as IV injection over 2 minutes within 120 minutes of stroke onset
Placebo_comparator: Placebo
Matching placebo given as IV injection over 2 minutes within 120 minutes of stroke onset
Related Therapeutic Areas
Sponsors
Collaborators: Novo Nordisk A/S, National Institute of Neurological Disorders and Stroke (NINDS)
Leads: Joseph Broderick, MD

This content was sourced from clinicaltrials.gov