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Clinical Trial 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 ICH within a time window and subgroup of patients that is most likely to benefit. Our central hypothesis is that rFVIIa, administered within 120 minutes from onset with an identified subgroup of subjects 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

Clinical Trial Description

The investigators will perform a global, Phase III, randomized, double-blind controlled trial of rFVIIa plus best standard therapy vs. placebo and best standard therapy alone. The investigators will include subjects with a volume of ICH < 60 cc, no IVH or a small volume of IVH (IVH score ≤ 7), age ≤ age 80, Glasgow Coma Scale of ≥ 8, and treated within 120 minutes from stroke onset. To minimize time-to-treatment, the study will use exemption from informed consent (EFIC) and mobile stroke care units (MSUs) with a goal of ½ of patients treated within 90 minutes as accomplished in the NINDS t-PA trials. At 100 hospital sites and 15 MSUs in the NINDS-funded StrokeNet, and key global institutions with large volumes of ICH patients and ability to treat them within 2 hours of onset, we plan to recruit 860 participants over 3 1/2 years. Countries planning to participate in the trial include the United States, Canada, Australia, Japan, Germany and Spain.

The investigators will randomize participants in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 8 mg dose) or placebo. Subjects in both arms will receive best medical therapy as per published AHA Guidelines for ICH, including a target blood pressure of 140 mm Hg. Primary outcome (ordinal mRS with the following categories: 0-2, 3, and 4-6) will be determined at 90 days, but we will follow participants by a telephone assessment at 30 days and 180 days. To measure growth of ICH, all subjects will have baseline non-contrast CT of the head and a repeat CT at 24 hours. The investigators will perform centralized volumetric measurements of ICH, IVH, and edema for both time points.

Novo Nordisk will manufacture and supply recombinant FVIIa as a research medication for use in the FASTEST Trial. Novo Nordisk will also manufacture and supply matching placebo that is identical in appearance and administration for the FASTEST Trial. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03496883
Study type Interventional
Source University of Cincinnati
Contact Joseph P Broderick, MD
Phone 513-919-5404
Status Not yet recruiting
Phase Phase 3
Start date January 2020
Completion date January 2026

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