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

Sponsored by Joseph Broderick, MD

About this study

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.

FASTEST Part 2 is 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 participants with a volume of ICH ≥ 2 and \< 60 cc, no more than a small volume of intraventricular hemorrhage (IVH) (less than 2/3 of one lateral ventricle and less than 1/3 in both lateral ventricles), age ≥ 18 and ≤ 80, Glasgow Coma Scale of ≥ 8, and with a positive spot sign on a baseline CTA treated within 120 minutes from stroke onset or patients treated within 90 minutes of stroke onset, with or without a positive spot sign. This is based upon data from FASTEST Part 1 from the overall FASTEST Trial where the greatest potential for benefit was demonstrated. To minimize time-to-treatment, the s…

Where this study is enrolling (49)

  • University of Alabama Hospital

    Birmingham, Alabama

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  • Ronald Reagan UCLA Medical Center

    Los Angeles, California

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  • San Francisco General Hospital

    San Francisco, California

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  • Kaiser Permanente West Los Angeles Medical Center

    Los Angeles, California

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  • UCSD Medical Center - Hillcrest Hospital

    San Diego, California

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Who can participate

Inclusion criteria

  • ✓1. Patients aged 18-80 years, inclusive
  • ✓2. Patients with spontaneous ICH
  • ✓3. Able to treat with study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well with a positive spot sign on pretreatment CT angiography or treatment within 90 minutes with or without spot sign.
  • ✓4. Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, Finland, U.K., Japan, Australia)

Exclusion criteria

  • ✕1. Score of 3 to 7 on the Glasgow Coma Scale
  • ✕2. 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.)
  • ✕3. ICH volume \< 2 cc or ≥ 60 cc
  • ✕4. Blood filling 2/3 or more of one lateral ventricle of the brain, OR, blood filling at least 1/3 of both lateral ventricles.
  • ✕5. Pre-existing disability (mRS \> 2)
  • ✕6. Symptomatic thrombotic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction, pulmonary embolus, deep vein thrombosis, or unstable angina)
  • ✕7. Clinical or EKG evidence of ST elevation consistent with acute myocardial ischemia
  • ✕8. Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled)
  • ✕9. Refusal to participate in study by patient, legal representative, or family member
  • ✕10. Known or suspected thrombocytopenia (unless current platelet count documented above 50,000/μL)
  • ✕11. Unfractionated heparin use with abnormal PTT
  • ✕12. Pro-coagulant drugs within 24 hours prior to patient enrollment into the FASTEST trial (example, tranexamic acid or aminocaproic acid)
  • ✕13. Low-molecular weight heparin use within the previous 24 hours
  • ✕14. Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting
  • ✕15. Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered
  • ✕16. Recent (within 30 days) participation in any investigational drug or device trial or earlier participation in any investigational drug or device trial for which the duration of effect is expected to persist until to the time of FASTEST enrollment
  • ✕17. Planned withdrawal of care or comfort care measures
  • ✕18. Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism, drug dependency, or psychological disorder)
  • ✕19. Known or suspected allergy to trial medication(s), excipients, or related products
  • ✕20. Contraindications to study medication
  • ✕21. Previous participation in this trial (previously randomized)
  • ✕22. Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment -

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Trial data sourced from ClinicalTrials.gov.