At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- Mix of remote tasks and in-person visits
- Drug or intervention
- Recombinant Factor VIIa (biological), Biological/Vaccine: Placebo (biological)
- How long the study runs
- Study runs about 49 months (dates as stated)
- About the drug or intervention
- 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. · 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.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at whether a drug called recombinant factor VIIa (rFVIIa), a clotting protein, can help people who have had a bleed in the brain (a type of stroke called intracerebral haemorrhage). The drug is compared with a placebo (a dummy treatment with no active medicine). People must be treated very quickly after their stroke starts.
Who can take part
- Aged 18 to 80 years
- Had a spontaneous bleed in the brain (not caused by injury or another known cause)
- Able to receive the study medicine within 120 minutes of stroke onset (or within 90 minutes), in line with the trial's timing rules
- Emergency consent rules are followed, according to each country's regulations
Who may not be able to
- Very low level of consciousness (Glasgow Coma Scale score of 3 to 7)
- Bleed caused by injury, an aneurysm, an abnormal tangle of blood vessels, blood-thinning medicines in the past 7 days, or a clotting problem
- Bleed in the brain is smaller than 2 cc or 60 cc or larger
- A lot of blood has filled the fluid-filled spaces (ventricles) in the brain
- Already had a disability before the stroke
- Had a blood clot problem in the past 90 days, such as a stroke, heart attack, blood clot in the lungs or leg, or unstable angina
- Signs of a current heart attack on tests
- Bleed is in the brainstem
- Patient, family, or legal representative says no to taking part
- Low platelet count (unless a recent test shows it is above 50,000 per microlitre)
- Recent use of certain blood-thinning or clot-helping medicines (heparin, low-molecular-weight heparin, tranexamic acid, or aminocaproic acid)
- Recent surgery or stenting on blood vessels (within the past 90 days)
- Serious illness where the study drug could be harmful
- Took part in another research study of a drug or device in the past 30 days (or earlier if its effects could still be present)
- Planned withdrawal of care or comfort care only
- Cannot follow the study plan, for example because of alcohol or drug problems or a mental health condition
- Known or suspected allergy to the study medicines or their ingredients
- Any reason the study drug must not be given
- Already took part in this trial before
- Pregnant, within 12 weeks after giving birth, or breastfeeding
What taking part involves
- • A single dose of the study drug (rFVIIa) or a placebo (dummy medicine), given through a drip soon after the stroke
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 350
- Started
- 2025-05-06
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for intracerebral hemorrhage
- • Phase3 - 350 participants
- • 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
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with intracerebral hemorrhage
Where?
- • Oxford - John Radcliffe Hospital
- • Stoke-on-Trent - Royal Stoke University Hospital
- • Newcastle upon Tyne - Royal Victoria Infirmary
- • Nottingham - Queens Medical Centre
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This 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 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.
More detail
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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 80 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Patients aged 18-80 years, inclusive
- ✓Patients with spontaneous ICH
- ✓Efforts to obtain agreement to take part per EFIC guidelines (U.S.) or adherence to country-specific emergency research...
Who cannot take part
- ✗Score of 3 to 7 on the Glasgow Coma Scale
- ✗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...
- ✗Pre-existing disability (mRS \> 2)
- ✗causing symptoms thrombotic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction,...
See the full criteria
Where Is This Study? (4 UK sites)
John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent ST4 6QG, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Queens Medical Centre
Nottingham, United Kingdom
How to Get in Touch
Joseph P Broderick, MD
Sponsor contactCONTACT
James Grotta, MD
Sponsor contactCONTACT