Active — Not RecruitingPhase 3

Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

United States860 participantsStarted 2021-12-03

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Patients aged 18-80 years, inclusive
✓. Patients with spontaneous ICH
✓. Able to treat with study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well
✓. Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, U.K., Japan)

Exclusion criteria

✕. Score of 3 to 7 on the Glasgow Coma Scale
✕. Secondary ICH related to known causes (e.g., trauma, aneurysm, arteriovenous malformation (AVM), oral anticoagulant use (vitamin K antagonists or novel oral anticoagulants) within the past 7 days, coagulopathy, etc.)
✕. ICH volume \< 2 cc or ≥ 60 cc
✕. Blood filling 2/3 or more of one lateral ventricle of the brain, OR, blood filling at least 1/3 of both lateral ventricles.
✕. Pre-existing disability (mRS \> 2)
✕. Symptomatic thrombotic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction, pulmonary embolus, deep vein thrombosis, or unstable angina)
✕. Clinical or EKG evidence of ST elevation consistent with acute myocardial ischemia
✕. Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled)

What they're measuring

Modified Rankin Scale (mRS)

Timeframe: 180 days

Trial details

NCT IDNCT03496883

SponsorJoseph Broderick, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-01

View on ClinicalTrials.gov More Intracerebral Hemorrhage trials