Intracerebral HemorrhagePhase 3FASTEST Part 2NCT07227246
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2
A Phase 3 study testing Recombinant Factor VIIa in people with Intracerebral Hemorrhage, run by Joseph Broderick, MD at 89 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Recombinant Factor VIIa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 89 sitesin 6 countries
- Study dates
- 6 May 2025to Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 with a positive spot sign on pretreatment CT angiography or treatment within 90 minutes with or without spot sign.
- Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, Finland, U.K., Japan, Australia)
Who cannot join
- 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)
Show all 22Show fewer
- 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
- Recent (within 30 days) participation in any investigational drug or device trial or earlier participation in any investigational drug or device trial for which the duration of effect is expected to persist until to the time of FASTEST enrollment
- Planned withdrawal of care or comfort care measures
- Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism, drug dependency, or psychological disorder)
- Known or suspected allergy to trial medication(s), excipients, or related products
- Contraindications to study medication
- Previous participation in this trial (previously randomized)
- Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment -
Trial locations and contacts
89 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
89 sites in 6 countries
United States49 sites, 49 recruiting
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30303
Digvijaya Navalkele, MD, MPH, digvijaya.navalkele@emory.edu
- Recruiting
Kaiser Permanente Baldwin Park Medical Center
Baldwin Park, California, 91706
Navdeep Sangha, MD, Navdeep.X.Sangha@kp.org
- Recruiting
University of Alabama Hospital
Birmingham, Alabama, 35233
Elizabeth Liptrap, MD, elizabethle@uabmc.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Pierre Borczuk, MD, Borczuk.Pierre@mgh.harvard.edu
- Recruiting
Mills Peninsula Medical Center
Burlingame, California, 94010
Ilana Spokoyny, MD, spokoyi@sutterhealth.org
- Recruiting
M Health Fairview Ridges Hospital,
Burnsville, Minnesota, 55337
Christopher Streib, MD, streib@umn.edu
- Recruiting
Medical University of South Carolina University Hospital
Charleston, South Carolina, 29425
Christine Holmstedt, MD, holmsted@musc.edu
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Babak S. Jahromi, MD, PhD, Babak.Jahromi@nm.org
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Ali Mansour, MD, ali.mansour@uchospitals.edu
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45229
Kyle Walsh, MD, walshk4@ucmail.uc.edu
- Recruiting
OSU Wexner Medical Center
Columbus, Ohio, 43210
Yousef Hannawi, MD, Yousef.Hannawi@osumc.edu
- Recruiting
Riverside Methodist Hospital
Columbus, Ohio, 43214
William J Hicks, MD, william.hicks@ohiohealth.com
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48208
Christopher A Lewandowski, MD, CLEWAND1@hfhs.org
- Recruiting
Kaiser Permanente Downey Medical Center
Downey, California, 90242
Navdeep Sangha, MD, Navdeep.X.Sangha@kp.org
- Recruiting
M Health Fairview Southdale Hospital
Edina, Minnesota, 55435
Christopher Streib, MD, cdstreib@umn.edu
- Recruiting
Kaiser Permanente Fontana Medical Center
Fontana, California, 92335
Navdeep Sangha, MD, Navdeep.X.Sangha@kp.org
- Recruiting
UF Health Shands Hospital
Gainesville, Florida, 32608
Anna Y Khanna, MD, anna.khanna@neurology.ufl.edu
- Recruiting
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Sanjeev Sivakumar, MD, sanjeev.sivakumar@prismahealth.org
- Recruiting
Kaiser Permanente South Bay Medical Center
Harbor City, California, 90710
Navdeep Sangha, MD, Navdeep.X.Sangha@kp.org
- Recruiting
The Queen's Medical Center
Honolulu, Hawaii, 96813
Chung-Huan Sun, MD, chsun@queens.org
- Recruiting
Memorial Hermann Memorial City Medical Center
Houston, Texas, 77024
Ritvij Bowry, MD, Ritvij.Bowry@uth.tmc.edu
- Recruiting
Memorial Hermann-Texas Medical Center
Houston, Texas, 77030
James Grotta, MD, james.c.grotta@uth.tmc.edu
- Recruiting
University of Florida Jacksonville (UF Health)
Jacksonville, Florida, 32209
Benjamin T Alwood, MD, (904) 383-1022, Benjamin.Alwood@jax.ufl.edu
Yasmeen Shabbir, yasmeen.shabbir@ufhealth.org
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Lauren K Ng, MD, Ng.Lauren@mayo.edu
- Recruiting
UCSD Health La Jolla
La Jolla, California, 92037
Brett Meyer, MD, bcmeyer@health.ucsd.edu
- Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Navdeep S Sangha, MD, navdeep.x.sangha@kp.org
- Recruiting
Kaiser Permanente West Los Angeles Medical Center
Los Angeles, California, 90034
Navdeep Sangha, MD, Navdeep.X.Sangha@kp.org
- Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
May Nour, MD, PhD, MNour@mednet.ucla.edu
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
Richard Elias Temes, MD, Rtemes@northwell.edu
- Recruiting
M Health Fairview St. John's Hospital
Maplewood, Minnesota, 55109
Christopher Streib, MD, streib@umn.edu
- Recruiting
WellStar Kennestone Hospital
Marietta, Georgia, 30060
Raisa C. Martinez, MD, Raisa.MartinezMartinez@wellstar.org
- Recruiting
M Health Fairview University of Minnesota Medical Center Hospital,
Minneapolis, Minnesota, 55455
Christopher Streib, MD, streib@umn.edu
- Recruiting
Mount Sinai West
New York, New York, 10019
John W Liang, MD, john.liang@mountsinai.org
- Recruiting
The Mount Sinai Hospital
New York, New York, 10029
John Liang, MD, John.Liang@mountsinai.org
- Recruiting
UC Irvine Medical Center,
Orange, California, 92868
Jay Shah, MD, jshah@uci.edu
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Nina T Gentile, MD, ngentile@temple.edu
- Recruiting
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Ted J Lowenkopf, MD, Theodore.Lowenkopf@providence.org
- Recruiting
VCU Medical Center
Richmond, Virginia, 23219
Dennis J. Rivet, MD, dennis.rivet@vcuhealth.org
- Recruiting
Kaiser Permanente Riverside Medical Center
Riverside, California, 92505
Navdeep S Sangha, MD, Navdeep.X.Sangha@kp.org
- Recruiting
Mayo Clinic Saint Marys Campus
Rochester, Minnesota, 55902
Eugene L. Scharf, M.D., scharf.eugene@mayo.edu
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
Lara L Zimmermann, MD, LLZimmermann@ucdavis.edu
- Recruiting
University of Utah Healthcare
Salt Lake City, Utah, 84132
Ramesh Grandhi, MD, MS, ramesh.grandhi@hsc.utah.edu
- Recruiting
UCSD Medical Center - Hillcrest Hospital
San Diego, California, 92103
Brett Meyer, MD, bcmeyer@health.ucsd.edu
- Recruiting
San Francisco General Hospital
San Francisco, California, 94110
Vineeta Singh, MD, vineeta.singh@ucsf.edu
- Recruiting
Barnes Jewish Hospital
St Louis, Missouri, 63110
Peter D Panagos, MD, panagospd@wustl.edu
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Jason Mathew, DO, Jason.Mathew@stonybrookmedicine.edu
- Recruiting
St. John Medical Center
Tulsa, Oklahoma, 74104
Errol L Gordon, MD, Errol.gordon@ascension.org
- Recruiting
Central DuPage Hospital
Winfield, Illinois, 60190
Harish N. Showkeen, MD, harish_shownkeen@cdh.org
- Recruiting
UMass Memorial Medical Center
Worcester, Massachusetts, 01605
Adalia H. Jun-O'Connell, MD, Adalia.Jun@umassmemorial.org
Japan13 sites, 13 recruiting
- Recruiting
Kyushu Medical Center
Fukuoka
Yasushi Okada, MD, okada.yasushi.yh@mail.hosp.go.jp
- Recruiting
Gifu University Hospital
Gifu
Toru Iwama, MD, tiwama@gifu-u.ac.jp
- Recruiting
Kagoshima City Hospital
Kagoshima
Fumio Miyashita, MD, fu-miya@xc4.so-net.ne.jp
- Recruiting
Kobe City Medical Center General Hospital
Kobe
Nobuyuki Sakai, MD, n.sakai@siren.ocn.ne.jp
- Recruiting
Japanese Red Cross Kyoto Daini Hospital
Kyoto
Yoshinari Nagakane, MD, ynagakane@gmail.com
- Recruiting
Niigata City General Hospital
Niigata
Kenichi Morita, MD, PhD, kmt@bri.niigata-u.ac.jp
- Recruiting
KMU University Hospital
Osaka
Yusuke Yakushiji, MD, yakushiy@hirakata.kmu.ac.jp
- Recruiting
NHO Osaka National Hospital
Osaka
Toshiyuki Fujinaka, MD, fujinaka@nsurg.med.osaka-u.ac.jp
- Recruiting
Nakamura Memorial Hospital
Sapporo
Kenji Kamiyama, MD, ikamirin911@med.nmh.or.jp
- Recruiting
Jichi Medical University Hospital
Shimotsuke
Shigeru Fujimoto, MD, PhD, shigeruf830@jichi.ac.jp
- Recruiting
National Cerebral and Cardiovascular Center
Suita, Osaka, 564-8565
Kazunori Toyoda, MD,PhD,FAHA, toyoda@ncvc.go.jp
- Recruiting
Kyorin University Hospital
Tokyo
Teruyuki Hirano, MD, PhD, terry@ks.kyorin-u.ac.jp
- Recruiting
Toranomon Hospital
Tokyo
Takayuki Hara, MD, thara@toranomon.gr.jp
Canada9 sites, 9 recruiting
- Recruiting
University of Calgary - Foothills Medical Centre
Calgary, Alberta
Andrew M Demchuk, MD, PhD, ademchuk@ucalgary.ca
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, AB T6G 2B7
Brian H. Buck, MD, FRCPC, bbuck@ualberta.ca
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Ashkan Shoamanesh, MD, ashkan.shoamanesh@phri.ca
- Recruiting
University of Montreal Hospital
Montreal, Quebec, H2X 3E4
Laura C Gioia, MD, MSc, laura.gioia@umontreal.ca
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Dar Dowlatshahi, MD, ddowlat@toh.ca
- Recruiting
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5
Houman Khosravani, MD PhD FRCPC, Houman.Khosravani@sunnybrook.ca
- Recruiting
St. Michaels Hospital
Toronto, Ontario, M5B 1W8
Alexandra Muccilli, MD, 416-864-5377, alexandra.muccilli@unityhealth.to
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Ming Yin Dominic TSE, MD, dominic.tse@vch.ca
- Recruiting
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, R3A 1R9
Nishita Singh, MD, DM, MSc, 204-787-7772, nishita.singh@umanitoba.ca
Germany7 sites, 7 recruiting
- Recruiting
University Hospital Augsburg
Augsburg, 86156
Hauke Schneider, Dr. med., hauke.schneider@uk-augsburg.de
- Recruiting
Charite University Medicine Berlin
Berlin
Christian Nolte, MD, christian.nolte@charite.de
- Recruiting
University Hospital Erlangen
Erlangen, Bavaria, 91054
Stefan T Gerner, MD, +49 9131 85-33001, Stefan.Gerner@uk-erlangen.de
- Recruiting
Clinic Frankfurt Hoechst
Frankfurt am Main, Hesse
Thorsten Steiner, MD, thorsten.steiner@icloud.com
- Recruiting
University Medical Center Hamburg
Hamburg, 20246
Götz Thomalla, MD, +49 (0) 40 7410 - 50137, thomalla@uke.de
- Recruiting
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Jan C Purrucker, MD, jan.purrucker@med.uni-heidelberg.de
- Recruiting
University Hospital Tuebingen
Tübingen, 72076
Sven Poli, Dr. med., sven.poli@uni-tuebingen.de
Spain7 sites, 7 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 21A 08916
Alejandro Bustamante Rangel, MD
- Recruiting
Santa Creu and Sant Pau Hospital
Barcelona, Catalonia, 08025
Joan Martí-Fàbregas, MD,PhD, jmarti@santpau.cat
- Recruiting
Girona University Hospital
Girona, Catalonia, 17007
Yolanda Silva Blas, MD, PhD, ysilva.girona.ics@gencat.cat
- Recruiting
Vall d'Hebron University Hospital (VHUH)
Horta, Barcelona
Carlos A. Molina, MD, PhD, cmolina@vhebron.net
- Recruiting
Bellvitge University Hospital,
L'Hospitalet de Llobregat, Barcelona, 08907
Pere Cardona Portela, MD, pcardonap@bellvitgehospital.cat
- Recruiting
Arnau de Vilanova University Hospital
Lleida, Catalonia, 25198
Francisco Purroy Garcia, MD PhD, fpurroy.lleida.ics@gencat.cat
- Recruiting
Valladolid University Hospital
Valladolid, 47002
Juan F Arenillas Lara, MD, 0034 983 420 000-86874, juanfarenillas@gmail.com
United Kingdom4 sites, 4 recruiting
- Recruiting
Royal Victoria Infirmary
Newcastle upon Tyne
Tudor Gheorghiu, MD, tudor.gheorghiu1@nhs.net
- Recruiting
Queens Medical Centre
Nottingham
Ganesh Subramanian, MB, FRCP, M Ed, M Res, Ganesh.subramanian@nuh.nhs.uk
- Recruiting
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Philip Mathieson, MD, Phil.Mathieson@ouh.nhs.uk
- Recruiting
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG
Indira Natarajan, FRCP, MSc
About this study
Official title: Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial - Part 2
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.
Read the detailed description
FASTEST Part 2 is a global, Phase III, randomized, double-blind controlled trial of rFVIIa plus best standard therapy vs. placebo and best standard therapy alone. The investigators will include participants with a volume of ICH ≥ 2 and < 60 cc, no more than a small volume of intraventricular hemorrhage (IVH) (less than 2/3 of one lateral ventricle and less than 1/3 in both lateral ventricles), age ≥ 18 and ≤ 80, Glasgow Coma Scale of ≥ 8, and with a positive spot sign on a baseline CTA treated within 120 minutes from stroke onset or patients treated within 90 minutes of stroke onset, with or without a positive spot sign. This is based upon data from FASTEST Part 1 from the overall FASTEST Trial where the greatest potential for benefit was demonstrated. To minimize time-to-treatment, the study uses emergency research informed consent procedures (including exception from informed consent (EFIC) in the United States) and mobile stroke units (MSUs), with a goal of ½ of participants treated within 90 minutes, as accomplished in the NINDS t-PA trials. The FASTEST Trial will include approximately 100 hospital sites and at least 15 MSUs in the NINDS-funded StrokeNet and key global institutions with large volumes of ICH patients and the ability to treat them within 120 minutes of stroke onset.
Recruitment of a maximum of 350 participants over approximately 3½ years is planned. Countries participating in the trial include the United States, Canada, Japan, Germany, Spain, Finland, the United Kingdom, and Australia. Involving other countries may be possible in the future depending upon recruitment needs.
Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or 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. The primary outcome (ordinal mRS with the following categories: 0-2, 3, and 4-6) will be determined at 90 days, but participants will be followed by remote assessment at 30 days and 180 days. To measure growth of ICH, all participants will have a standard of care baseline non-contrast CT of the head and a repeat scan at 24 hours. Centralized volumetric measurements of ICH, IVH, and edema will be performed for both time points.
Novo Nordisk A/S will manufacture and supply rFVIIa as a research medication for use in the FASTEST Trial. Novo Nordisk A/S will also manufacture and supply matching placebo that is identical to rFVIIa in appearance and administration.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Recombinant Factor VIIa, Biological/Vaccine: Placebo
- Keywords
- Intracerebral hemorrhage, recombinant factor VIIa
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Factor VIIaBiological
Also called NovoSeven NiaStase
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: PlaceboBiological
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 group | Role | What they receive |
|---|---|---|
| Recombinant Factor VIIa | Experimental | rFVIIa given as IV injection over 2 minutes within 120 minutes of stroke onset Receives: Biological: Recombinant Factor VIIa |
| Placebo | Placebo comparator | Placebo given as IV injection over 2 minutes within 120 minutes of stroke onset Receives: Biological: Biological/Vaccine: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale
Ordinal distribution with the following steps: 0-2, 3, 4-6
Measured: 90 days
Secondary outcomes (9)
Modified Rankin Scale
Utility-Weighted
Measured: 90 days
Modified Rankin Scale
0-2
Measured: 90 days
Modified Rankin Scale
Ordinal distribution with the following steps: 0-2, 3, 4-6
Measured: 180 days
Modified Rankin Scale
Ordinal
Measured: 90 days
Modified Rankin Scale
Utility-weighted
Measured: 180 days
Modified Rankin Scale
0-2
Measured: 180 days
EQ-5D
Quality of life scale
Measured: 90 days
EQ-5D
Quality of life scale
Measured: 180 days
Change in the volume of ICH and ICH+IVH
As measured by non-contrast CT of head
Measured: Between baseline and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start6 May 2025
- Primary completionJan 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph Broderick, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Japan Agency for Medical Research and Development, Novo Nordisk A/S
- Responsible party
- Sponsor-investigator, Joseph Broderick, MD, University of Cincinnati
- Investigators
- Joseph P Broderick, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227246
- Sponsor's protocol ID
- Ucincinnatifastestpart2
- Other IDs
- U01NS110772-04
- Acronym
- FASTEST Part 2
- Status last verified
- Aug 2026
- First submitted
- 9 Nov 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results to be reported on ClinicalTrials.gov, and trial database prepared for NINDS for sharing with other investigators
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial - Part 2
- ClinicalTrials.gov ID
- NCT07227246
- Acronym / sponsor ID
- FASTEST Part 2 / Ucincinnatifastestpart2
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral hemorrhage, recombinant factor VIIa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Joseph Broderick, MDUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Japan Agency for Medical Research and Development, Novo Nordisk A/S
- Study start
- 6 May 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
FASTEST Part 2 is a global, Phase III, randomized, double-blind controlled trial of rFVIIa plus best standard therapy vs. placebo and best standard therapy alone. The investigators will include participants with a volume of ICH ≥ 2 and < 60 cc, no more than a small volume of intraventricular hemorrhage (IVH) (less than 2/3 of one lateral ventricle and less than 1/3 in both lateral ventricles), age ≥ 18 and ≤ 80, Glasgow Coma Scale of ≥ 8, and with a positive spot sign on a baseline CTA treated within 120 minutes from stroke onset or patients treated within 90 minutes of stroke onset, with or without a positive spot sign. This is based upon data from FASTEST Part 1 from the overall FASTEST Trial where the greatest potential for benefit was demonstrated. To minimize time-to-treatment, the study uses emergency research informed consent procedures (including exception from informed consent (EFIC) in the United States) and mobile stroke units (MSUs), with a goal of ½ of participants treated within 90 minutes, as accomplished in the NINDS t-PA trials. The FASTEST Trial will include approximately 100 hospital sites and at least 15 MSUs in the NINDS-funded StrokeNet and key global institutions with large volumes of ICH patients and the ability to treat them within 120 minutes of stroke onset.
Recruitment of a maximum of 350 participants over approximately 3½ years is planned. Countries participating in the trial include the United States, Canada, Japan, Germany, Spain, Finland, the United Kingdom, and Australia. Involving other countries may be possible in the future depending upon recruitment needs.
Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or 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. The primary outcome (ordinal mRS with the following categories: 0-2, 3, and 4-6) will be determined at 90 days, but participants will be followed by remote assessment at 30 days and 180 days. To measure growth of ICH, all participants will have a standard of care baseline non-contrast CT of the head and a repeat scan at 24 hours. Centralized volumetric measurements of ICH, IVH, and edema will be performed for both time points.
Novo Nordisk A/S will manufacture and supply rFVIIa as a research medication for use in the FASTEST Trial. Novo Nordisk A/S will also manufacture and supply matching placebo that is identical to rFVIIa in appearance and administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Factor VIIa | Experimental | Biological: Recombinant Factor VIIarFVIIa given as IV injection over 2 minutes within 120 minutes of stroke onset |
| Placebo | Placebo comparator | Biological: Biological/Vaccine: PlaceboPlacebo given as IV injection over 2 minutes within 120 minutes of stroke onset |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 with a positive spot sign on pretreatment CT angiography or treatment within 90 minutes with or without spot sign.
- Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, Finland, U.K., Japan, Australia)
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Factor VIIaAlso: NovoSeven NiaStaseParticipants 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 | Recombinant Factor VIIa |
| Biological/Vaccine: PlaceboParticipants 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 | Placebo |
Primary outcome
Modified Rankin Scale
Time frame: 90 days
Ordinal distribution with the following steps: 0-2, 3, 4-6
9 secondary outcomes
Modified Rankin Scale
Time frame: 90 days
Modified Rankin Scale
Time frame: 90 days
Modified Rankin Scale
Time frame: 180 days
Modified Rankin Scale
Time frame: 90 days
Modified Rankin Scale
Time frame: 180 days
Modified Rankin Scale
Time frame: 180 days
EQ-5D
Time frame: 90 days
EQ-5D
Time frame: 180 days
Change in the volume of ICH and ICH+IVH
Time frame: Between baseline and 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Results to be reported on ClinicalTrials.gov, and trial database prepared for NINDS for sharing with other investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph P Broderick principal investigator
University of Cincinnati
89 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Factor VIIa in people with Intracerebral Hemorrhage, run by Joseph Broderick, MD at 89 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States, Japan, Canada, Germany, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph P Broderick, MD (15139195404, broderjp@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.