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

Part 2: Testing rFVIIa for treating hemorrhagic stroke.

Recruiting
18-80 years
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

Recombinant Factor VIIa (rFVIIa) is a treatment being studied for a type of stroke called hemorrhagic stroke, which is bleeding in the brain. This trial, called the FASTEST Trial, aims to test if rFVIIa can help patients who get treated quickly after a stroke starts. A CT scan and a Modified Rankin Score (mRS), a scale for measuring the effects of a stroke, will help doctors understand the treatment's impact. Participants will receive either rFVIIa or a placebo (a substance with no active medicine) along with standard stroke care.

  • The trial will last about 3½ years and involve up to 350 participants from countries like the US, Canada, and others.
  • Patients must be 18-80 years old and can be treated within 90-120 minutes after a stroke begins.
  • Participants will have follow-up assessments at 30, 90, and 180 days after treatment.

This study uses special consent procedures to allow quick treatment. Emergency services and mobile stroke units will be involved to treat patients as soon as possible.

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Study details
    Intracerebral Hemorrhage

NCT07227246

Joseph Broderick, MD

17 October 2026

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