FVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial

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Project Summary Recombinant Factor VIIa (rFVIIa) for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is a randomized, double-blind, controlled global trial of rFVIIa plus best standard therapy vs. best standard therapy alone for patients with intracerebral hemorrhage (ICH). Our central hypothesis is 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 90 days, as compared to placebo. We will test our hypothesis in 860 patients recruited at 100 hospital sites and at least 15 mobile stroke units (MSUs) within the NINDS StrokeNet (70 sites) and key global institutions (30 sites) with large volumes of patients with ICH and ability to treat within 2 hours of onset. Participating countries include the U.S., Canada, United Kingdom, Germany, Spain, Japan, and Australia. We will include subjects with a volume of ICH < 60 cc, no intraventricular hemorrhage (IVH) or a small volume of IVH (IVH score ≤ 7), age ≤ 80, GCS ≥ 8, and treated within 120 minutes from last known normal. To minimize time-to-treatment, the study will use exception from informed consent and MSUs with a goal of ½ of patients treated within 90 minutes as accomplished in the NINDS t-PA trials. We will recruit the 860 patients over 3 1/2 years and randomize them in a double-blinded fashion to rFVIIa 80 micrograms/kg dose (maximum 8mg 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. The primary efficacy outcome measure is the ordinal distribution of the mRS at 90 days. Primary safety outcomes will include ischemic events (cerebral infarction, myocardial infarction, and pulmonary embolus) within 4 days of study medication. To measure growth of ICH and IVH, all subjects will have baseline non- contrast CT and at 24 hours. Centralized volumetric measurements of ICH, IVH, and edema will be done for both time-points. The overall principal investigators (PIs) for the Trial include Joseph Broderick, James Grotta, Andrew Naidech, and Jordan Elm (primary statistical PI) as well as PIs for each participating non-U.S. country. In summary, the goal of FAST is to find the first scientifically proven treatment for acute ICH.