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Clotting Factor

rFVIIa for Hemorrhagic Stroke (FASTEST Trial)

Phase 3

Recruiting

Research Sponsored by Joseph Broderick, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with spontaneous ICH

Able to treat with study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well

Must not have

Contraindications to study medication

Pre-existing disability (mRS > 2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days

Awards & highlights

FASTEST Trial Summary

This trial is testing whether a drug called rFVIIa can improve outcomes for people who have had a spontaneous intracerebral hemorrhage (ICH), if it is given within 120 minutes of the stroke.

Who is the study for?

This trial is for adults aged 18-80 who've had a spontaneous hemorrhagic stroke and can start treatment within 2 hours of onset. It's not for those with certain pre-existing conditions, drug dependencies, recent participation in other trials, or women who are pregnant/lactating. Patients must be able to follow the trial protocol.Check my eligibility

What is being tested?

The FASTEST Trial is testing if Recombinant Activated Factor VII (rFVIIa), given quickly after a hemorrhagic stroke starts, can improve recovery at six months compared to standard care. Half will get rFVIIa and half a placebo to see which works better.See study design

What are the potential side effects?

Potential side effects of rFVIIa include allergic reactions, increased risk of blood clots leading to events like heart attack or deep vein thrombosis, and possibly others related to bleeding disorders.

FASTEST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a stroke caused by bleeding in my brain.

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I can take the study medication within 2 hours of my stroke or when I was last well.

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic or sensitive to the study medication.

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I have a significant disability before joining the study.

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I have signs of a heart attack on my EKG or from symptoms.

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I have had surgery or stenting for heart or brain vessels within the last 3 months.

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I am not pregnant, within 12 weeks after giving birth, or breastfeeding.

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I, or my legal representative/family, do not consent to participate in the study.

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I haven't taken any blood clotting drugs in the last 24 hours.

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I am using heparin and my blood test for clotting time is abnormal.

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I am planning to receive only comfort care.

FASTEST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Modified Rankin Scale (mRS)

Secondary outcome measures

Change in the volume of ICH and ICH+IVH

EQ-5D

mRS

FASTEST Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Recombinant Activated Factor VII (rFVIIa)Active Control1 Intervention

rFVIIa given as IV injection over 2 minutes within 120 minutes of stroke onset

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo given as IV injection over 2 minutes within 120 minutes of stroke onset

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Joseph Broderick, MDLead Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,349 Previous Clinical Trials

647,317 Total Patients Enrolled

173 Trials studying Stroke

81,072 Patients Enrolled for Stroke

Novo Nordisk A/SIndustry Sponsor

1,525 Previous Clinical Trials

2,418,876 Total Patients Enrolled

1 Trials studying Stroke

380 Patients Enrolled for Stroke

Media Library

Recombinant Activated Factor VII (rFVIIa) (Clotting Factor) Clinical Trial Eligibility Overview. Trial Name: NCT03496883 — Phase 3

Stroke Research Study Groups: Recombinant Activated Factor VII (rFVIIa), Placebo

Stroke Clinical Trial 2023: Recombinant Activated Factor VII (rFVIIa) Highlights & Side Effects. Trial Name: NCT03496883 — Phase 3

Recombinant Activated Factor VII (rFVIIa) (Clotting Factor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03496883 — Phase 3

~490 spots leftby Jan 2028

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