Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

80 Years

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)
Refusal to participate in study by patient, legal representative, or family member
Known or suspected thrombocytopenia (unless current platelet count documented above 50,000/μL)
Unfractionated heparin use with abnormal PTT
Pro-coagulant drugs within 24 hours prior to patient enrollment into the FASTEST trial (example, tranexamic acid or aminocaproic acid)
Low-molecular weight heparin use within the previous 24 hours
Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting
Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered
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
Planned withdrawal of care or comfort care measures
Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism, drug dependency, or psychological disorder)
Known or suspected allergy to trial medication(s), excipients, or related products
Contraindications to study medication
Previous participation in this trial (previously randomized)
Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment