RecruitingPHASE3INTERVENTIONAL

Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2

This study, called FASTEST Part 2, is looking for a way to treat a serious type of stroke known as a hemorrhagic stroke, which is bleeding in the brain. Doctors are testing a medicine called rFVIIa to see if it can help patients recover better and stop the bleeding from getting worse. They believe giving this medicine very soon after the stroke, especially within 90-120 minutes, could make a big difference for specific patients. The study wants to find out if rFVIIa, combined with standard care, is better than standard care alone for improving a patient's health 90 days after the stroke. They are focusing on patients aged 18-80 who meet certain criteria for the bleeding in their brain.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Joseph Broderick, MD

Enrolment target

350

Start

06 May 2025

Estimated completion

01 Jun 2029

Intracerebral Hemorrhage

What is this study about?

Imagine your brain is like a complex computer, and sometimes a blood vessel can burst, causing a 'short circuit' – this is called a hemorrhagic stroke. This type of stroke can be very serious. This study, called FASTEST Part 2, is trying to find the very first specific treatment for this kind of stroke that can be given quickly. Current treatments often focus on managing the symptoms, but this study hopes to find a medicine that directly helps with the bleeding.

The main idea behind FASTEST Part 2 is that giving a medicine called rFVIIa very soon after the bleeding starts – ideally within 90 to 120 minutes – might help. This medicine is thought to help the blood clot faster, which could stop the bleeding from getting worse. The researchers want to see if this quick treatment can improve how well people recover after 90 days and reduce the amount of ongoing bleeding, compared to just getting standard care.

This study is building on findings from an earlier part of the FASTEST trial. They've found that certain groups of patients might benefit most. For example, those treated within 2 hours who show a specific sign on a brain scan (called a 'spot sign'), or those treated even faster, within 90 minutes, might see the best results. The study aims to recruit patients from various countries, including the UK, and compare the new medicine with a 'dummy' medicine (placebo) alongside the usual care.

Key takeaways

Tests a new medicine (rFVIIa) for bleeding strokes.
Aims to improve recovery by stopping brain bleeding quickly.
Treatment needs to start very fast, within 90-120 minutes.
Compares the new medicine to a dummy pill (placebo) plus standard care.
Recruits patients aged 18-80 with a specific type of brain bleed.
Follow-up for recovery is over 90 days.

Who may be eligible?

To join this study, you would need to be between 18 and 80 years old and have experienced a spontaneous bleeding stroke. You would also need to be able to receive the study medicine very quickly after your stroke – either within two hours if a scan shows a particular bleeding pattern (called a 'spot sign'), or within 90 minutes regardless of this scan sign.

There are also some reasons why you might not be able to join. For example, if your stroke was caused by something specific like a head injury, an aneurysm (a bulge in a blood vessel), or if you were taking certain blood-thinning medicines just before the stroke. You also couldn't join if the bleeding in your brain is too small or too large, or if you have severe brain swelling caused by the bleeding. People with certain serious heart or blood clot problems in the last three months, or those who are already very ill, would also not be eligible.

Quick self-check

Are you between 18 and 80 years old?
Did you recently have a bleeding stroke?
Can treatment be started within 90-120 minutes of your stroke?
Was your stroke not caused by injury, an aneurysm, or certain blood thinners?
Is the amount of blood in your brain within specific limits?
Do you have a Glasgow Coma Scale score of 8 or higher (meaning you're fairly responsive)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you are eligible and agree to take part, you would be randomly assigned to receive either the study medicine (rFVIIa) or a placebo, which looks identical but has no active ingredient. You wouldn't know which one you're getting, and neither would your doctors. Both groups would also receive the best standard care for your type of stroke, according to current guidelines, including managing your blood pressure. The main focus is on giving the treatment very quickly, within 90 to 120 minutes of your stroke. After this initial treatment, doctors will monitor your condition closely. Your recovery will be checked at different times, with the main assessment happening 90 days after your stroke. This assessment will help understand how well you are managing daily activities. The entire study involves being closely monitored and having follow-up assessments over this 90-day period.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. One potential benefit of this study is that the treatment being tested might help to improve recovery from your bleeding stroke and reduce further bleeding. However, because it's a study, there's no guarantee this will happen, and you might receive the placebo. Potential risks could include side effects from the study medicine or other complications, although the researchers will monitor you very closely for any issues. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (89)

University of Alabama Hospital
Birmingham, United States· Recruiting
Kaiser Permanente Baldwin Park Medical Center
Baldwin Park, United States· Recruiting
Mills Peninsula Medical Center
Burlingame, United States· Recruiting
Kaiser Permanente Downey Medical Center
Downey, United States· Recruiting
Kaiser Permanente Fontana Medical Center
Fontana, United States· Recruiting
Kaiser Permanente South Bay Medical Center
Harbor City, United States· Recruiting
UCSD Health La Jolla
La Jolla, United States· Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles, United States· Recruiting
Kaiser Permanente West Los Angeles Medical Center
Los Angeles, United States· Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles, United States· Recruiting
UC Irvine Medical Center,
Orange, United States· Recruiting
Kaiser Permanente Riverside Medical Center
Riverside, United States· Recruiting

+77 more sites — see the official record for the full list.

Common questions

What is a hemorrhagic stroke?

It's a type of stroke caused by a blood vessel bursting in the brain, leading to bleeding.

What is rFVIIa?

It's a medicine being tested to help blood clot faster and potentially stop bleeding in the brain.

Why is quick treatment so important?

The study believes that treating the stroke very quickly, within 90-120 minutes, might give the best chance for recovery.

Will I know if I'm getting the real medicine?

No, it's a 'blinded' study, meaning neither you nor your doctors will know if you're getting the medicine or the placebo.

How long does the study follow-up last?

Your recovery will be closely watched, with the main assessment taking place 90 days after your stroke.

How to find out more

Joseph P Broderick, MD

broderjp@ucmail.uc.edu 15139195404 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.