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

ConditionIntracerebral Hemorrhage
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJoseph Broderick, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 with a positive spot sign on pretreatment CT angiography or treatment within 90 minutes with or without spot sign.

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Recombinant Factor VIIa

    Biological/Vaccine

    Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. All participants in FASTEST Part 2 must have a positive spot sign on baseline CTA and be treated within 120 minutes of onset or patients treated within 90 minutes of stroke onset, with or without a positive spot sign. Participants in both arms will receive best standard therapy as per published AHA Guidelines for ICH, including a target systolic blood pressure of 140 mm Hg.

  • Biological/Vaccine: Placebo

    Biological/Vaccine

    Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. All participants in FASTEST Part 2 must have a positive spot sign on baseline CTA and be treated within 120 minutes of onset or patients treated within 90 minutes of stroke onset, with or without a positive spot sign. Participants in both arms will receive best standard therapy as per published AHA Guidelines for ICH, including a target systolic blood pressure of 140 mm Hg.

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Recombinant Factor VIIaExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Modified Rankin Scale

Ordinal distribution with the following steps: 0-2, 3, 4-6

Time frame
90 days

Secondary outcomes

1

Modified Rankin Scale

Utility-Weighted

Time frame
90 days
2

Modified Rankin Scale

0-2

Time frame
90 days
3

Modified Rankin Scale

Ordinal distribution with the following steps: 0-2, 3, 4-6

Time frame
180 days
4

Modified Rankin Scale

Ordinal

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Joseph Broderick, MD

Lead sponsor

University of Cincinnati

Sponsor institution

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Japan Agency for Medical Research and Development

Collaborator

Novo Nordisk A/S

Collaborator

Source ClinicalTrials.gov
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