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rFVIIa for Hemorrhagic Stroke (FASTEST Trial)
FASTEST Trial Summary
This trial is testing whether a drug called rFVIIa can improve outcomes for people who have had a spontaneous intracerebral hemorrhage (ICH), if it is given within 120 minutes of the stroke.
FASTEST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFASTEST Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FASTEST Trial Design
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Who is running the clinical trial?
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- I am not allergic or sensitive to the study medication.My bleeding is in the brainstem or cerebellum.You have a lot of blood in part of your brain called the ventricles.I have had a clot or blockage in my blood vessels in the last 3 months.Your Glasgow Coma Scale score is between 3 and 7.I have a significant disability before joining the study.I have signs of a heart attack on my EKG or from symptoms.You have low platelet count unless it is above 50,000/μL.I have had surgery or stenting for heart or brain vessels within the last 3 months.You have a serious illness or condition that the doctor thinks could be very risky if you were given rFVIIa.I have had a stroke caused by bleeding in my brain.I have had a brain bleed due to a specific cause like injury or blood thinner use in the last week.I am not pregnant, within 12 weeks after giving birth, or breastfeeding.I can take the study medication within 2 hours of my stroke or when I was last well.I, or my legal representative/family, do not consent to participate in the study.I haven't taken any blood clotting drugs in the last 24 hours.I am between 18 and 80 years old.Your brain bleed is less than 2 cubic centimeters or more than 60 cubic centimeters.I am using heparin and my blood test for clotting time is abnormal.I am planning to receive only comfort care.I have used a blood thinner in the last 24 hours.
- Group 1: Recombinant Activated Factor VII (rFVIIa)
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the target age group for this trial over 40 years old?
"This specific trial is for patients aged 18 to 80. However, there are a total of 62 clinical trials underway for those under 18 and 340 for patients over 65 years old."
In how many different places is this trial being run today?
"Currently, there are 24 sites enrolling patients for this study. To try and make the burden of participation as small as possible, researchers have spread these sites across Toledo, Winston-Salem, Winfield and other locations."
Are there other ongoing or completed studies that have used rFVIIa?
"There are currently 8 clinical trials studying Recombinant Activated Factor VII (rFVIIa), with 4 of them in Phase 3. 96 different trial sites are investigating this topic, with some locations in Dijon and Massachusetts."
How many people are currently enrolled in this trial?
"The sponsor, Novo Nordisk A/S, needs to recruit 860 individuals that match the study's eligibility requirements. The trial will take place in different locations such as Toledo Hospital located in Toledo, Ohio and Wake Forest Baptist Medical Center situated in Winston-Salem, North carolina."
What is the significance of this trial in the medical world?
"There have been a total of 8 clinical trials for Recombinant Activated Factor VII (rFVIIa) across 51 cities and 10 countries since the first one was held in 2018. The initial study, which was sponsored by CSL Behring, reached Phase 3 approval after involving 60 participants. A total of 18357 studies have been completed as of now."
Could I please receive more information on the requirements for this particular medical study?
"This study is recruiting 860 individuals who have suffered a cerebral hemorrhage and fall between 18-80 years old. Most importantly, the following inclusion criteria must be met: Being able to administer the study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well, Aged 18-80 years, inclusive, Patients with spontaneous ICH, Having given informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, U.K., Japan)."
What are some of the primary conditions that rFVIIa treats?
"Recombinant Activated Factor VII (rFVIIa), which is commonly used to treat hemophilia, can also be an effective intervention for hemorrhage and surgery."
Could you explain any health risks associated with rFVIIa?
"There is already some data suggesting that rFVIIa is effective and safe, so our team has given it a score of 3."
Are volunteers still being enrolled in this research program?
"The trial is still open and recruiting patients, according to the information available on clinicaltrials.gov. The listing for the study was first posted on December 3rd, 2021 and has since been updated on November 14th, 2022."
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