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

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 90 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. FASTEST Part 2 is an extension of the FASTEST Trial where the subgroups include those treated within 2 hours with a positive spot sign on a baseline CT angiogram or patients treated within 90 minutes of stroke onset, with or without a positive spot sign.

NCT Number	NCT07227246
Lead Sponsor	Joseph Broderick, MD Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Japan Agency for Medical Research and Development, Novo Nordisk A/S
Conditions	Intracerebral Hemorrhage
Enrollment	350 participants
Start Date	2025-05-06
Primary Completion	2029-01 (estimated)
Study Completion	2029-06 (estimated)
Updated on ClinicalTrials.gov	2026-04-22