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

April 21, 2026 updated by: Joseph Broderick, MD

Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial - Part 2

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 study uses emergency research informed consent procedures (including exception from informed consent (EFIC) in the United States) and mobile stroke units (MSUs), with a goal of ½ of participants treated within 90 minutes, as accomplished in the NINDS t-PA trials. The FASTEST Trial will include approximately 100 hospital sites and at least 15 MSUs in the NINDS-funded StrokeNet and key global institutions with large volumes of ICH patients and the ability to treat them within 120 minutes of stroke onset.

Recruitment of a maximum of 350 participants over approximately 3½ years is planned. Countries participating in the trial include the United States, Canada, Japan, Germany, Spain, Finland, the United Kingdom, and Australia. Involving other countries may be possible in the future depending upon recruitment needs.

Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or 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. The primary outcome (ordinal mRS with the following categories: 0-2, 3, and 4-6) will be determined at 90 days, but participants will be followed by remote assessment at 30 days and 180 days. To measure growth of ICH, all participants will have a standard of care baseline non-contrast CT of the head and a repeat scan at 24 hours. Centralized volumetric measurements of ICH, IVH, and edema will be performed for both time points.

Novo Nordisk A/S will manufacture and supply rFVIIa as a research medication for use in the FASTEST Trial. Novo Nordisk A/S will also manufacture and supply matching placebo that is identical to rFVIIa in appearance and administration.

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Recruiting
        • University of Calgary - Foothills Medical Centre
        • Contact:
      • Edmonton, Alberta, Canada, AB T6G 2B7
        • Recruiting
        • University of Alberta Hospital
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Recruiting
        • Health Sciences Centre Winnipeg
        • Contact:
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa Hospital Research Institute
        • Contact:
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5B 1W8
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
  • Germany
      • Augsburg, Germany, 86156
      • Berlin, Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • University Medical Center Hamburg
        • Contact:
          • Götz Thomalla, MD
          • Phone Number: +49 (0) 40 7410 - 50137
          • Email: thomalla@uke.de
      • Tübingen, Germany, 72076
    • Baden-Wurttemberg
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
    • Hesse
      • Frankfurt am Main, Hesse, Germany
  • Japan
    • Osaka
      • Suita, Osaka, Japan, 564-8565
        • Recruiting
        • National Cerebral and Cardiovascular Center
        • Contact:
  • Spain
      • Valladolid, Spain, 47002
        • Recruiting
        • Valladolid University Hospital
        • Contact:
    • Barcelona
      • Badalona, Barcelona, Spain, 21A 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
        • Contact:
          • Alejandro Bustamante Rangel, MD
      • Horta, Barcelona, Spain
        • Recruiting
        • Vall d'Hebron University Hospital (VHUH)
        • Contact:
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    • Catalonia
      • Barcelona, Catalonia, Spain, 08025
        • Recruiting
        • Santa Creu and Sant Pau Hospital
        • Contact:
      • Girona, Catalonia, Spain, 17007
      • Lleida, Catalonia, Spain, 25198
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom
      • Nottingham, United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • Recruiting
        • Royal Stoke University Hospital
        • Contact:
          • Indira Natarajan, FRCP, MSc
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
    • California
      • Baldwin Park, California, United States, 91706
        • Recruiting
        • Kaiser Permanente Baldwin Park Medical Center
        • Contact:
      • Burlingame, California, United States, 94010
      • Downey, California, United States, 90242
      • Fontana, California, United States, 92335
      • Harbor City, California, United States, 90710
      • La Jolla, California, United States, 92037
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Los Angeles Medical Center
        • Contact:
      • Los Angeles, California, United States, 90095
      • Los Angeles, California, United States, 90034
        • Recruiting
        • Kaiser Permanente West Los Angeles Medical Center
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Medical Center,
        • Contact:
      • Riverside, California, United States, 92505
        • Recruiting
        • Kaiser Permanente Riverside Medical Center
        • Contact:
      • Sacramento, California, United States, 95817
      • San Diego, California, United States, 92103
      • San Francisco, California, United States, 94110
    • Florida
      • Gainesville, Florida, United States, 32608
      • Jacksonville, Florida, United States, 32224
    • Georgia
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • The Queen's Medical Center
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Contact:
      • Winfield, Illinois, United States, 60190
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Worcester, Massachusetts, United States, 01605
    • Michigan
      • Detroit, Michigan, United States, 48208
        • Recruiting
        • Henry Ford Hospital
        • Contact:
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • M Health Fairview Ridges Hospital,
        • Contact:
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • M Health Fairview Southdale Hospital
        • Contact:
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • M Health Fairview St. John's Hospital
        • Contact:
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • M Health Fairview University of Minnesota Medical Center Hospital,
        • Contact:
      • Rochester, Minnesota, United States, 55902
    • Missouri
      • St Louis, Missouri, United States, 63110
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital
        • Contact:
      • New York, New York, United States, 10019
      • New York, New York, United States, 10029
      • Stony Brook, New York, United States, 11794
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • University of Cincinnati Medical Center
        • Contact:
      • Columbus, Ohio, United States, 43214
      • Columbus, Ohio, United States, 43210
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
    • Oregon
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina University Hospital
        • Contact:
      • Greenville, South Carolina, United States, 29605
    • Texas
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77024
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • Virginia
      • Richmond, Virginia, United States, 23219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recombinant Factor VIIa
rFVIIa given as IV injection over 2 minutes within 120 minutes of stroke onset
Biological: Recombinant Factor VIIa
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.
Other Names:
  • NovoSeven NiaStase
Placebo Comparator: Placebo
Placebo given as IV injection over 2 minutes within 120 minutes of stroke onset
Biological: Biological/Vaccine: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale
Time Frame: 90 days
Ordinal distribution with the following steps: 0-2, 3, 4-6
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D
Time Frame: 180 days
Quality of life scale
180 days
EQ-5D
Time Frame: 90 days
Quality of life scale
90 days
Modified Rankin Scale
Time Frame: 180 days
Ordinal distribution with the following steps: 0-2, 3, 4-6
180 days
Modified Rankin Scale
Time Frame: 90 days
Utility-Weighted
90 days
Modified Rankin Scale
Time Frame: 90 days
0-2
90 days
Modified Rankin Scale
Time Frame: 90 days
Ordinal
90 days
Modified Rankin Scale
Time Frame: 180 days
Utility-weighted
180 days
Modified Rankin Scale
Time Frame: 180 days
0-2
180 days
Change in the volume of ICH and ICH+IVH
Time Frame: Between baseline and 24 hours
As measured by non-contrast CT of head
Between baseline and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph Broderick, MD

Collaborators

Novo Nordisk A/S
National Institute of Neurological Disorders and Stroke (NINDS)
Japan Agency for Medical Research and Development

Investigators

  • Principal Investigator: Joseph P Broderick, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

November 9, 2025

First Submitted That Met QC Criteria

November 10, 2025

First Posted (Actual)

November 12, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ucincinnatifastestpart2
  • U01NS110772-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results to be reported on ClinicalTrials.gov, and trial database prepared for NINDS for sharing with other investigators

IPD Sharing Time Frame

Available 12 months after publication of primary results

IPD Sharing Access Criteria

Approval by NINDS

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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