Testing Recombinant Factor VIIa against a placebo for intracerebral hemorrhage
Official title: Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2
Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial - Part 2
- Phase 3
- 2 groups
- Sites in Calgary, Edmonton and 6 more cities
- Recruiting
Interventions
- Biological therapy
Recombinant Factor VIIa
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 therapy
Biological/Vaccine: Placebo
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.
Canadian Sites (9)
9 of 9 recruiting
- Recruiting
University of Calgary - Foothills Medical Centre
Calgary, Alberta
- Recruiting
University of Alberta Hospital
Edmonton, Alberta
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
- Recruiting
Health Sciences Centre Winnipeg
Winnipeg, Manitoba
- Recruiting
Hamilton General Hospital
Hamilton, Ontario
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario
- Recruiting
Sunnybrook Health Sciences Center
Toronto, Ontario
- Recruiting
St. Michaels Hospital
Toronto, Ontario
- Recruiting
University of Montreal Hospital
Montreal, Quebec
Eligibility Criteria
See who this study is looking for26 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients aged 18-80 years, inclusive
- +Patients with spontaneous ICH
- +Able to treat with study medication (rFVIIa/placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →) 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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, Finland, U.K., Japan, Australia)
Exclusion
- −Score of 3 to 7 on the Glasgow Coma Scale
- −Known or suspected allergy to trial medication(s), excipients, or related products
- −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 enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more →)
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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 protocolProtocolThe detailed plan a study must follow.Read more → (e.g., due to alcoholism, drug dependency, or psychological disorder)
- −Contraindications to study medication
- −Previous participation in this trial (previously randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →)
- −Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment -
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Recombinant Factor VIIa.
Registry label: A: Recombinant Factor VIIa
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Biological/Vaccine: Placebo.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 80 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 350 people.
The study is currently expected to finish around June 2029.
The main measurement is taken over: 90 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Modified Rankin Scale — measured over 90 days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07227246 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Recombinant Factor VIIaBiological
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.
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 80 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 80 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 90 days.
The study as a whole is currently expected to finish around 2029-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 350 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 17 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Hamilton, Ontario, Canada; Ottawa, Ontario, Canada, and 11 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (10)
Henry Ford Hospital
Detroit, Michigan, United States
M Health Fairview Ridges Hospital,
Burnsville, Minnesota, United States
M Health Fairview Southdale Hospital
Edina, Minnesota, United States
M Health Fairview St. John's Hospital
Maplewood, Minnesota, United States
M Health Fairview University of Minnesota Medical Center Hospital,
Minneapolis, Minnesota, United States
Mayo Clinic Saint Marys Campus
Rochester, Minnesota, United States
North Shore University Hospital
Manhasset, New York, United States
Mount Sinai West
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.