Acute Trial Ongoing NCT07227246ICH in Stroke

FASTEST: Part 2

Sponsor: NIH • Phase: III • Design: Randomized • Population: Adults

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Purpose

Primary Aims: To test the hypothesis that treatment with rFVIIa within two hours of onset in appropriately selected patients with spontaneous ICH improves outcome as measured by the ordinal distribution of the modified Rankin Scale (mRS) at 180 days, as compared to placebo. Secondary Specific Aim To test the hypothesis that treatment with rFVIIa within two hours of onset in appropriately selected patients with spontaneous ICH decreases bleeding between baseline and 24-hour head imaging, as compared to placebo.
Primary Endpoints: As per Food and Drug Administration (FDA) recommendation, the primary outcome measure is the following distribution of the ordinal mRS at 180 days: 0-2, 3, and 4-6. Secondary Endpoints Secondary endpoints include the ordinal mRS (all seven steps), utility-weighted Rankin Score,33 mRS of 0-2, and EQ-5D34,35 at 90 days and 180 days; and change in the volume of ICH and ICH+IVH between the baseline CT and 24-hour CT.

Study Overview

Key Eligibility (high-level)

Patients aged 18-80 years, with spontaneous ICH, who are eligible for study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well.

Study Design

FASTEST is a global, Phase III, randomized, double-blind controlled trial of rFVIIa plus best standard therapy vs. placebo and best standard therapy alone.

Sites & Participation

Approximately 115 hospital sites and 15 mobile stroke units (MSUs) in the NINDS-funded StrokeNet in the U.S. and key global institutions

Additional Resources

FASTEST Trial Resources

One-page overview for clinicians.

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FAQ

Who is eligible?

Patients aged 18-80 years
Patients with spontaneous ICH
Eligible for study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well.
Efforts to obtain informed consent per EFIC guidelines.