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Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

NCT03496883 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 860

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Intracerebral Hemorrhage

Interventions

BIOLOGICAL

Recombinant Activated Factor VII (rFVIIa)

Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. 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

Placebo

Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. 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.

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Joseph Broderick, MD

    lead OTHER

Principal Investigators

  • Joseph Broderick, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-03
Primary Completion
2028-01-01
Completion
2028-01-01
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Japan
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03496883 on ClinicalTrials.gov