Clinical Trial

Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

Study acronym: FASTEST
Active, Not Recruiting Phase 3
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Summary
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 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.
Protocol Amendment History 35 amendments
This ClinicalTrials.gov record has been amended 35 times since 2018-04-05; most recent amendment 2026-01-16.
Status change: Recruiting → Active, Not Recruiting 2026-01-16
Status change: Not Yet Recruiting → Recruiting 2021-09-28
Trial Details
NCT Number NCT03496883
Lead Sponsor Joseph Broderick, MD
Collaborators: Novo Nordisk A/S, National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Intracerebral Hemorrhage
Enrollment 860 participants
Start Date 2021-12-03
Primary Completion 2028-01-01 (estimated)
Study Completion 2028-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-21