Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial
FASTEST
4 other identifiers
interventional
860
6 countries
88
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2021
Longer than P75 for phase_3
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2018
CompletedFirst Posted
Study publicly available on registry
April 12, 2018
CompletedStudy Start
First participant enrolled
December 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
January 21, 2026
January 1, 2026
6.1 years
April 5, 2018
January 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Modified Rankin Scale (mRS)
Ordinal distribution with the following steps: 0-2, 3, 4-6
180 days
Secondary Outcomes (7)
mRS
180 days
mRS
180 days
EQ-5D
180 days
Change in the volume of ICH and ICH+IVH
Between baseline CT and 24-hour CT
mRS
90 days
- +2 more secondary outcomes
Study Arms (2)
Recombinant Activated Factor VII (rFVIIa)
ACTIVE COMPARATORrFVIIa given as IV injection over 2 minutes within 120 minutes of stroke onset
Placebo
PLACEBO COMPARATORMatching placebo given as IV injection over 2 minutes within 120 minutes of stroke onset
Interventions
Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. 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.
Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. 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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Score of 3 to 7 on the Glasgow Coma Scale
- Secondary ICH related to known causes (e.g., trauma, aneurysm, arteriovenous malformation (AVM), oral anticoagulant use (vitamin K antagonists or novel oral anticoagulants) within the past 7 days, coagulopathy, etc.)
- ICH volume \< 2 cc or ≥ 60 cc
- Blood filling 2/3 or more of one lateral ventricle of the brain, OR, blood filling at least 1/3 of both lateral ventricles.
- Pre-existing disability (mRS \> 2)
- Symptomatic thrombotic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction, pulmonary embolus, deep vein thrombosis, or unstable angina)
- Clinical or EKG evidence of ST elevation consistent with acute myocardial ischemia
- Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled)
- Refusal to participate in study by patient, legal representative, or family member
- Known or suspected thrombocytopenia (unless current platelet count documented above 50,000/μL)
- Unfractionated heparin use with abnormal PTT
- Pro-coagulant drugs within 24 hours prior to patient enrollment into the FASTEST trial (example, tranexamic acid or aminocaproic acid)
- Low-molecular weight heparin use within the previous 24 hours
- Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting
- Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joseph Broderick, MDlead
- Novo Nordisk A/Scollaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
Study Sites (88)
University of Alabama Hospital
Birmingham, Alabama, 35233, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Kaiser Permanente Baldwin Park Medical Center
Baldwin Park, California, 91706, United States
Mills Peninsula Medical Center
Burlingame, California, 94010, United States
Kaiser Permanente Downey Medical Center
Downey, California, 90242, United States
Kaiser Permanente Fontana Medical Center
Fontana, California, 92335, United States
Kaiser Permanente South Bay Medical Center
Harbor City, California, 90710, United States
UCSD Health La Jolla
La Jolla, California, 92037, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Kaiser Permanente West Los Angeles Medical Center
Los Angeles, California, 90034, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UC Irvine Medical Center,
Orange, California, 92868, United States
Kaiser Permanente Riverside Medical Center
Riverside, California, 92505, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
UCSD Medical Center - Hillcrest Hospital
San Diego, California, 92103, United States
San Francisco General Hospital
San Francisco, California, 94110, United States
UF Health Shands Hospital
Gainesville, Florida, 32608, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
WellStar Kennestone Hospital
Marietta, Georgia, 30060, United States
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01605, United States
Henry Ford Hospital
Detroit, Michigan, 48208, United States
M Health Fairview Ridges Hospital,
Burnsville, Minnesota, 55337, United States
M Health Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
M Health Fairview St. John's Hospital
Maplewood, Minnesota, 55109, United States
M Health Fairview University of Minnesota Medical Center Hospital,
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Saint Marys Campus
Rochester, Minnesota, 55902, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Mount Sinai West
New York, New York, 10019, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45229, United States
OSU Wexner Medical Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
St. John Medical Center
Tulsa, Oklahoma, 74104, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Medical University of South Carolina University Hospital
Charleston, South Carolina, 29425, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Memorial Hermann Memorial City Medical Center
Houston, Texas, 77024, United States
Memorial Hermann-Texas Medical Center
Houston, Texas, 77030, United States
University of Utah Healthcare
Salt Lake City, Utah, 84132, United States
VCU Medical Center
Richmond, Virginia, 23219, United States
University of Calgary - Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, AB T6G 2B7, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5, Canada
St. Michaels Hospital
Toronto, Ontario, M5B 1W8, Canada
University of Montreal Hospital
Montreal, Quebec, H2X 3E4, Canada
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Clinic Frankfurt Hoechst
Frankfurt am Main, Hesse, Germany
University Hospital Augsburg
Augsburg, 86156, Germany
Charite University Medicine Berlin
Berlin, Germany
University Hospital Tuebingen
Tübingen, 72076, Germany
National Cerebral and Cardiovascular Center
Suita, Osaka, 564-8565, Japan
Kyushu Medical Center
Fukuoka, Japan
Gifu University Hospital
Gifu, Japan
Kagoshima City Hospital
Kagoshima, Japan
Kobe City Medical Center General Hospital
Kobe, Japan
Japanese Red Cross Kyoto Daini Hospital
Kyoto, Japan
Iwate Prefectural Central Hospital
Morioka, Japan
Niigata City General Hospital
Niigata, Japan
KMU University Hospital
Osaka, Japan
NHO Osaka National Hospital
Osaka, Japan
Nakamura Memorial Hospital
Sapporo, Japan
Jichi Medical University Hospital
Shimotsuke, Japan
Kyorin University Hospital
Tokyo, Japan
Toranomon Hospital
Tokyo, Japan
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 21A 08916, Spain
Vall d'Hebron University Hospital (VHUH)
Horta, Barcelona, Spain
Bellvitge University Hospital,
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Santa Creu and Sant Pau Hospital
Barcelona, Catalonia, 08025, Spain
Girona University Hospital
Girona, Catalonia, 17007, Spain
Arnau de Vilanova University Hospital
Lleida, Catalonia, 25198, Spain
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Queens Medical Centre
Nottingham, United Kingdom
Related Publications (4)
Broderick JP, Naidech AM, Elm JJ, Toyoda K, Dowlatshahi D, Demchuk AM, Khatri P, Steiner T, Bath PM, Audebert HJ, Vagal A, Yoshimura S, Mayer SA, Wang LL, Sabagha N, Mocco JD, Molina C, Aviv R, Stinson E, Quadri SA, Carrozzella J, Huynh T, Phan A, Beall J, Davis I, Sakai N, Ohta T, Yokosawa M, Hara T, Sangha N, Morita K, Dominc Tse MY, Streib CD, Miyashita F, Silva Y, Nagakane Y, Gheorghiu T, Sun CH, Hirano T, Poli S, Izumo T, Fukuda-Doi M, Ihara M, Koga M, Buck B, Walsh KB, Spokovny I, Grotta JC; FASTEST Investigators. Recombinant factor VIIa versus placebo for spontaneous intracerebral haemorrhage within 2 h of symptom onset (FASTEST): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2026 Feb 21;407(10530):773-783. doi: 10.1016/S0140-6736(26)00097-8. Epub 2026 Feb 4.
PMID: 41653933DERIVEDYu W, Alexander MJ. Spontaneous intracerebral hemorrhage: Recent advances and critical thinking on future clinical trial design. Chin Med J (Engl). 2024 Dec 20;137(24):2899-2906. doi: 10.1097/CM9.0000000000003408. Epub 2024 Dec 10. No abstract available.
PMID: 39654449DERIVEDEilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
PMID: 37870112DERIVEDNaidech AM, Grotta J, Elm J, Janis S, Dowlatshahi D, Toyoda K, Steiner T, Mayer SA, Khanolkar P, Denlinger J, Audebert HJ, Molina C, Khatri P, Sprigg N, Vagal A, Broderick JP. Recombinant factor VIIa for hemorrhagic stroke treatment at earliest possible time (FASTEST): Protocol for a phase III, double-blind, randomized, placebo-controlled trial. Int J Stroke. 2022 Aug;17(7):806-809. doi: 10.1177/17474930211042700. Epub 2021 Sep 5.
PMID: 34427473DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Broderick, MD
University of Cincinnati
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Blinded study medication
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 5, 2018
First Posted
April 12, 2018
Study Start
December 3, 2021
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Available 12 months after publication of primary results
- Access Criteria
- Approval by NINDS
Results to be reported on ClinicalTrials.gov, and trial database prepared for NINDS for sharing with other investigators