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Trial record 1 of 1 for:    FASTEST | hemorrhagic stroke
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Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (FASTEST)

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ClinicalTrials.gov Identifier: NCT03496883
Recruitment Status : Not yet recruiting
First Posted : April 12, 2018
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
Novo Nordisk A/S
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Joseph Broderick, MD, University of Cincinnati

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 ICH within a time window and subgroup of patients that is most likely to benefit. Our central hypothesis is that rFVIIa, administered within 120 minutes from onset with an identified subgroup of subjects 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

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Biological: Recombinant Activated Factor VII (rFVIIa) Drug: Placebos Phase 3

Detailed Description:

The investigators will perform 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 subjects with a volume of ICH < 60 cc, no IVH or a small volume of IVH (IVH score ≤ 7), age ≤ age 80, Glasgow Coma Scale of ≥ 8, and treated within 120 minutes from stroke onset. To minimize time-to-treatment, the study will use exemption from informed consent (EFIC) and mobile stroke care units (MSUs) with a goal of ½ of patients treated within 90 minutes as accomplished in the NINDS t-PA trials. At 100 hospital sites and 15 MSUs in the NINDS-funded StrokeNet, and key global institutions with large volumes of ICH patients and ability to treat them within 2 hours of onset, we plan to recruit 860 participants over 3 1/2 years. Countries planning to participate in the trial include the United States, Canada, Australia, Japan, Germany and Spain.

The investigators will randomize participants in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or placebo. Subjects in both arms will receive best medical therapy as per published AHA Guidelines for ICH, including a target blood pressure of 140 mm Hg. Primary outcome (ordinal mRS with the following categories: 0-2, 3, and 4-6) will be determined at 180 days, but we will follow participants by a telephone assessment at 30 days and 90 days. To measure growth of ICH, all subjects will have baseline non-contrast CT of the head and a repeat CT at 24 hours. The investigators will perform centralized volumetric measurements of ICH, IVH, and edema for both time points.

Novo Nordisk will manufacture and supply recombinant FVIIa as a research medication for use in the FASTEST Trial. Novo Nordisk will also manufacture and supply matching placebo that is identical in appearance and administration for the FASTEST Trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 860 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Blinded study medication
Primary Purpose: Treatment
Official Title: Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Recombinant Activated Factor VII (rFVIIa)
FVIIa given as IV injection over 2 minutes within 2 hours of symptom onset
Biological: Recombinant Activated Factor VII (rFVIIa)
Investigators will randomize participants in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. Subjects in both arms will receive best medical therapy as per published AHA Guidelines for ICH, including a target blood pressure of 140 mm Hg.
Other Name: NovoSeven

Placebo Comparator: Placebo
Matching placebo given as IV injection over 2 minutes within 2 hours of symptom onset
Drug: Placebos
Investigators will randomize participants in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. Subjects in both arms will receive best medical therapy as per published AHA Guidelines for ICH, including a target blood pressure of 140 mm Hg.




Primary Outcome Measures :
  1. Modified Rankin Scale (mRS) [ Time Frame: 180 days ]
    Ordinal distribution of mRS with the following steps: 0-2, 3, and 4-6.


Secondary Outcome Measures :
  1. Utility-weighted mRS [ Time Frame: 180 days ]
    Utility-weighted

  2. mRS [ Time Frame: 180 days ]
    Score of 0-2

  3. EQ-5d [ Time Frame: 180 days ]
    Quality of life scale

  4. Change in the volume of ICH and ICH +IVH . [ Time Frame: Between baseline CT and 24 hour CT. ]
    As measured by CT of the head

  5. mRS [ Time Frame: 90 days ]
    Ordinal distribution of mRS - obtained by Telephone

  6. EQ-5d [ Time Frame: 90 days ]
    Quality of life scale

  7. ordinal distribution of mRS [ Time Frame: 90 days ]
    all seven steps



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ICH patients aged 18-80 years with spontaneous ICH
  2. Able to treat with rFVIIa within 120 minutes of stroke onset or last known well
  3. Efforts to obtain informed consent per EFIC guidelines

Exclusion Criteria:

  1. Score of 3 to 7 on the Glasgow Coma Scale (indicating deep coma).
  2. Secondary ICH related known causes (e.g. trauma, aneurysm, AVM, current oral anticoagulant use, coagulopathy, etc.)
  3. ICH volume < 2 cc and ≥ 60 cc
  4. IVH score > 7
  5. Pre-existing disability (mRS > 2)
  6. Symptomatic thrombo-embolic or vaso-occlusive disease in past 90 days (e.g. cerebral infarction/ischemic stroke, 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. Low-molecular weight heparin use within the previous 24 hours.
  13. Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting
  14. Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered.
  15. 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.
  16. Planned withdrawal of care or comfort care measures
  17. Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism, drug dependency or psychological disorder).
  18. Known or suspected allergy to trial medication(s), excipients, or related products
  19. Contraindications to study medication.
  20. Previous randomization in this trial.
  21. Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496883


Contacts
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Contact: Joseph P Broderick, MD 513-919-5404 joseph.broderick@uc.edu
Contact: James Grotta, MD 281-387-2329 James.C.Grotta@uth.tmc.edu

Sponsors and Collaborators
Joseph Broderick, MD
Novo Nordisk A/S
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Joseph P Broderick, MD University of Cincinnati
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Responsible Party: Joseph Broderick, MD, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03496883    
Other Study ID Numbers: UCincinnatifastest
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results to be reported on clinical trials.gov and trial database prepared for NINDS for sharing with other investigators.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 12 months after publication of primary results
Access Criteria: Approval by NINDS

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases