Intracerebral HemorrhagePhase 3FASTESTNCT03496883
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial
A Phase 3 study testing Recombinant Activated Factor VII (rFVIIa) in people with Intracerebral Hemorrhage, run by Joseph Broderick, MD at 88 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 Activated Factor VII (rFVIIa)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 860 participants
- Where
- 88 sitesin 6 countries
- Study dates
- 3 Dec 2021to 1 Jan 2028
- 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
- 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)
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
88 sites in 6 countries.
88 sites in 6 countries
United States51 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Kaiser Permanente Baldwin Park Medical Center
Baldwin Park, California, 91706
University of Alabama Hospital
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mills Peninsula Medical Center
Burlingame, California, 94010
M Health Fairview Ridges Hospital,
Burnsville, Minnesota, 55337
Medical University of South Carolina University Hospital
Charleston, South Carolina, 29425
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Cincinnati Medical Center
Cincinnati, Ohio, 45229
OSU Wexner Medical Center
Columbus, Ohio, 43210
Riverside Methodist Hospital
Columbus, Ohio, 43214
Henry Ford Hospital
Detroit, Michigan, 48208
Kaiser Permanente Downey Medical Center
Downey, California, 90242
M Health Fairview Southdale Hospital
Edina, Minnesota, 55435
Kaiser Permanente Fontana Medical Center
Fontana, California, 92335
UF Health Shands Hospital
Gainesville, Florida, 32608
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Kaiser Permanente South Bay Medical Center
Harbor City, California, 90710
The Queen's Medical Center
Honolulu, Hawaii, 96813
Memorial Hermann Memorial City Medical Center
Houston, Texas, 77024
Memorial Hermann-Texas Medical Center
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
UCSD Health La Jolla
La Jolla, California, 92037
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Kaiser Permanente West Los Angeles Medical Center
Los Angeles, California, 90034
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
North Shore University Hospital
Manhasset, New York, 11030
M Health Fairview St. John's Hospital
Maplewood, Minnesota, 55109
WellStar Kennestone Hospital
Marietta, Georgia, 30060
M Health Fairview University of Minnesota Medical Center Hospital,
Minneapolis, Minnesota, 55455
Mount Sinai West
New York, New York, 10019
The Mount Sinai Hospital
New York, New York, 10029
UC Irvine Medical Center,
Orange, California, 92868
Temple University Hospital
Philadelphia, Pennsylvania, 19140
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Providence St. Vincent Medical Center
Portland, Oregon, 97225
VCU Medical Center
Richmond, Virginia, 23219
Kaiser Permanente Riverside Medical Center
Riverside, California, 92505
Mayo Clinic Saint Marys Campus
Rochester, Minnesota, 55902
UC Davis Medical Center
Sacramento, California, 95817
University of Utah Healthcare
Salt Lake City, Utah, 84132
UCSD Medical Center - Hillcrest Hospital
San Diego, California, 92103
San Francisco General Hospital
San Francisco, California, 94110
Barnes Jewish Hospital
St Louis, Missouri, 63110
Stony Brook University Hospital
Stony Brook, New York, 11794
Toledo Hospital
Toledo, Ohio, 43606
St. John Medical Center
Tulsa, Oklahoma, 74104
Central DuPage Hospital
Winfield, Illinois, 60190
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
UMass Memorial Medical Center
Worcester, Massachusetts, 01605
Japan14 sites
Kyushu Medical Center
Fukuoka
Gifu University Hospital
Gifu
Kagoshima City Hospital
Kagoshima
Kobe City Medical Center General Hospital
Kobe
Japanese Red Cross Kyoto Daini Hospital
Kyoto
Iwate Prefectural Central Hospital
Morioka
Niigata City General Hospital
Niigata
KMU University Hospital
Osaka
NHO Osaka National Hospital
Osaka
Nakamura Memorial Hospital
Sapporo
Jichi Medical University Hospital
Shimotsuke
National Cerebral and Cardiovascular Center
Suita, Osaka, 564-8565
Kyorin University Hospital
Tokyo
Toranomon Hospital
Tokyo
Canada8 sites
University of Calgary - Foothills Medical Centre
Calgary, Alberta
University of Alberta Hospital
Edmonton, Alberta, AB T6G 2B7
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
University of Montreal Hospital
Montreal, Quebec, H2X 3E4
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5
St. Michaels Hospital
Toronto, Ontario, M5B 1W8
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Spain6 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 21A 08916
Santa Creu and Sant Pau Hospital
Barcelona, Catalonia, 08025
Girona University Hospital
Girona, Catalonia, 17007
Vall d'Hebron University Hospital (VHUH)
Horta, Barcelona
Bellvitge University Hospital,
L'Hospitalet de Llobregat, Barcelona, 08907
Arnau de Vilanova University Hospital
Lleida, Catalonia, 25198
Germany5 sites
University Hospital Augsburg
Augsburg, 86156
Charite University Medicine Berlin
Berlin
Clinic Frankfurt Hoechst
Frankfurt am Main, Hesse
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
University Hospital Tuebingen
Tübingen, 72076
United Kingdom4 sites
Royal Victoria Infirmary
Newcastle upon Tyne
Queens Medical Centre
Nottingham
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG
About this study
Official title: Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
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.
Read the detailed description
The investigators will perform 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) (IVH score ≤ 7), age ≥ 18 and ≤ 80, Glasgow Coma Scale of ≥ 8, and treated within 120 minutes from stroke onset. To minimize time-to-treatment, the study will use 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 860 participants over 3½ years is planned. Countries participating in the trial include the United States, Canada, Japan, Germany, Spain, and the United Kingdom. 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 180 days, but participants will be followed by remote assessment at 30 days and 90 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 Activated Factor VII (rFVIIa), Placebo
- 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 Activated Factor VII (rFVIIa)Biological
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. 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.
PlaceboBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Activated Factor VII (rFVIIa) | Active comparator | rFVIIa given as IV injection over 2 minutes within 120 minutes of stroke onset Receives: Biological: Recombinant Activated Factor VII (rFVIIa) |
| Placebo | Placebo comparator | Matching placebo given as IV injection over 2 minutes within 120 minutes of stroke onset Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS)
Ordinal distribution with the following steps: 0-2, 3, 4-6
Measured: 180 days
Secondary outcomes (7)
mRS
Utility-weighted
Measured: 180 days
mRS
Score of 0-2
Measured: 180 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 the head
Measured: Between baseline CT and 24-hour CT
mRS
Ordinal distribution
Measured: 90 days
EQ-5D
Quality of life scale
Measured: 90 days
mRS
Ordinal distribution
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start3 Dec 2021
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph Broderick, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph Broderick, MD, University of Cincinnati
- Investigators
- Joseph Broderick, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496883
- Sponsor's protocol ID
- UCincinnatifastest
- Other IDs
- 1U01NS110772-01, 2019-003722-25, U1111-1201-0087, 2019
- Acronym
- FASTEST
- Status last verified
- Jan 2026
- First submitted
- 5 Apr 2018
- Last updated
- 21 Jan 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
Publications
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.
PubMed 41653933Yu 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.
PubMed 39654449Eilertsen 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.
PubMed 37870112Naidech 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.
PubMed 34427473
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 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
- ClinicalTrials.gov ID
- NCT03496883
- Acronym / sponsor ID
- FASTEST / UCincinnatifastest
- Conditions
- Intracerebral Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 860 participants (estimated)
- Lead sponsor
- Joseph Broderick, MDUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 12 Apr 2018 (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 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.
Detailed description
The investigators will perform 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) (IVH score ≤ 7), age ≥ 18 and ≤ 80, Glasgow Coma Scale of ≥ 8, and treated within 120 minutes from stroke onset. To minimize time-to-treatment, the study will use 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 860 participants over 3½ years is planned. Countries participating in the trial include the United States, Canada, Japan, Germany, Spain, and the United Kingdom. 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 180 days, but participants will be followed by remote assessment at 30 days and 90 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 Activated Factor VII (rFVIIa) | Active comparator | Biological: Recombinant Activated Factor VII (rFVIIa)rFVIIa given as IV injection over 2 minutes within 120 minutes of stroke onset |
| Placebo | Placebo comparator | Biological: PlaceboMatching placebo 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
- 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)
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 Activated Factor VII (rFVIIa)Also: NovoSeven, NiaStaseParticipants 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. | Biological | Recombinant Activated Factor VII (rFVIIa) |
| PlaceboParticipants 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. | Biological | Placebo |
Primary outcome
Modified Rankin Scale (mRS)
Time frame: 180 days
Ordinal distribution with the following steps: 0-2, 3, 4-6
7 secondary outcomes
mRS
Time frame: 180 days
mRS
Time frame: 180 days
EQ-5D
Time frame: 180 days
Change in the volume of ICH and ICH+IVH
Time frame: Between baseline CT and 24-hour CT
mRS
Time frame: 90 days
EQ-5D
Time frame: 90 days
mRS
Time frame: 180 days
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 21 Jan 2026.
- Derived from this study: PubMed 41653933Broderick 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.
- Derived from this study: PubMed 39654449Yu 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.
- Derived from this study: PubMed 37870112Eilertsen 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.
- Derived from this study: PubMed 34427473Naidech 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.
- 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. This study is not recruiting at the moment.
Joseph Broderick, MD principal investigator
University of Cincinnati
88 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 Activated Factor VII (rFVIIa) in people with Intracerebral Hemorrhage, run by Joseph Broderick, MD at 88 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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in United States, Japan, Canada, Spain, Germany 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03496883, which also lists 4 linked publications.
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 21 Jan 2026.