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Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (FASTEST)

Primary Purpose

Intracerebral Hemorrhage

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Recombinant Activated Factor VII (rFVIIa)
Placebo
Sponsored by
Joseph Broderick, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  4. Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, U.K., Japan)

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. IVH score > 7
  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. 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 participation in this trial (previously randomized)
  21. Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment

Sites / Locations

  • University of Alabama HospitalRecruiting
  • St. Joseph's Hospital and Medical CenterRecruiting
  • Mills Peninsula Medical CenterRecruiting
  • UCSD Health La JollaRecruiting
  • Kaiser Permanente Los Angeles Medical CenterRecruiting
  • Ronald Reagan UCLA Medical CenterRecruiting
  • UC Irvine Medical Center,Recruiting
  • UC Davis Medical CenterRecruiting
  • UCSD Medical Center - Hillcrest HospitalRecruiting
  • Mayo ClinicRecruiting
  • Grady Memorial HospitalRecruiting
  • WellStar Kennestone HospitalRecruiting
  • The Queen's Medical CenterRecruiting
  • Northwestern Memorial HospitalRecruiting
  • University of Chicago Medical CenterRecruiting
  • Central DuPage HospitalRecruiting
  • Massachusetts General HospitalRecruiting
  • UMass Memorial Medical CenterRecruiting
  • Henry Ford HospitalRecruiting
  • M Health Fairview Ridges Hospital,Recruiting
  • M Health Fairview Southdale HospitalRecruiting
  • M Health Fairview St. John's HospitalRecruiting
  • M Health Fairview University of Minnesota Medical Center Hospital,Recruiting
  • Mayo Clinic Saint Marys CampusRecruiting
  • Regions HospitalRecruiting
  • Barnes Jewish HospitalRecruiting
  • Mount Sinai WestRecruiting
  • The Mount Sinai HospitalRecruiting
  • Stony Brook University HospitalRecruiting
  • Wake Forest Baptist Medical CenterRecruiting
  • University of Cincinnati Medical CenterRecruiting
  • OSU Wexner Medical CenterRecruiting
  • Riverside Methodist HospitalRecruiting
  • Toledo HospitalRecruiting
  • St. John Medical CenterRecruiting
  • Providence St. Vincent Medical CenterRecruiting
  • Temple University HospitalRecruiting
  • Medical University of South Carolina University HospitalRecruiting
  • Memorial Hermann Memorial City Medical CenterRecruiting
  • Memorial Hermann-Texas Medical CenterRecruiting
  • University of Utah HealthcareRecruiting
  • VCU Medical CenterRecruiting
  • University of Calgary - Foothills Medical CentreRecruiting
  • University of Alberta HospitalRecruiting
  • Vancouver General HospitalRecruiting
  • Hamilton General HospitalRecruiting
  • Ottawa Hospital Research InstituteRecruiting
  • Sunnybrook Health Sciences CenterRecruiting
  • University Hospital HeidelbergRecruiting
  • Clinic Frankfurt HoechstRecruiting
  • University Hospital AugsburgRecruiting
  • Charite University Medicine BerlinRecruiting
  • University Hospital TuebingenRecruiting
  • National Cerebral and Cardiovascular CenterRecruiting
  • Kyushu Medical CenterRecruiting
  • Gifu University HospitalRecruiting
  • Kagoshima City HospitalRecruiting
  • Kobe City Medical Center General HospitalRecruiting
  • Japanese Red Cross Kyoto Daini HospitalRecruiting
  • Iwate Prefectural Central HospitalRecruiting
  • Niigata City General HospitalRecruiting
  • KMU University HospitalRecruiting
  • NHO Osaka National HospitalRecruiting
  • Nakamura Memorial HospitalRecruiting
  • Jichi Medical University HospitalRecruiting
  • Kyorin University HospitalRecruiting
  • Toranomon HospitalRecruiting
  • Vall d'Hebron University Hospital (VHUH)Recruiting
  • Bellvitge University Hospital,Recruiting
  • Santa Creu and Sant Pau HospitalRecruiting
  • Girona University HospitalRecruiting
  • John Radcliffe HospitalRecruiting
  • Royal Stoke University HospitalRecruiting
  • Royal Victoria InfirmaryRecruiting
  • Queens Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Recombinant Activated Factor VII (rFVIIa)

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Modified Rankin Scale (mRS)
Ordinal distribution with the following steps: 0-2, 3, 4-6

Secondary Outcome Measures

mRS
Utility-weighted
mRS
Score of 0-2
EQ-5D
Quality of life scale
Change in the volume of ICH and ICH+IVH
As measured by non-contrast CT of the head
mRS
Ordinal distribution
EQ-5D
Quality of life scale
mRS
Ordinal distribution

Full Information

First Posted
April 5, 2018
Last Updated
September 13, 2023
Sponsor
Joseph Broderick, MD
Collaborators
Novo Nordisk A/S, National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT03496883
Brief Title
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial
Acronym
FASTEST
Official Title
Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
January 1, 2028 (Anticipated)
Study Completion Date
January 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph Broderick, MD
Collaborators
Novo Nordisk A/S, National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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 participants with a volume of ICH ≥ 2 and < 60 cc, no more than a small volume of intraventricular hemorrhage (IVH) (IVH score ≤ 7), age ≥ 18 and ≤ 80, Glasgow Coma Scale of ≥ 8, and treated within 120 minutes from stroke onset. To minimize time-to-treatment, the study will use 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 860 participants over 3½ years is planned. Countries participating in the trial include the United States, Canada, Japan, Germany, Spain, and the United Kingdom. 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 180 days, but participants will be followed by remote assessment at 30 days and 90 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Blinded study medication
Allocation
Randomized
Enrollment
860 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recombinant Activated Factor VII (rFVIIa)
Arm Type
Active Comparator
Arm Description
rFVIIa given as IV injection over 2 minutes within 120 minutes of stroke onset
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo given as IV injection over 2 minutes within 120 minutes of stroke onset
Intervention Type
Biological
Intervention Name(s)
Recombinant Activated Factor VII (rFVIIa)
Other Intervention Name(s)
NovoSeven, NiaStase
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Rankin Scale (mRS)
Description
Ordinal distribution with the following steps: 0-2, 3, 4-6
Time Frame
180 days
Secondary Outcome Measure Information:
Title
mRS
Description
Utility-weighted
Time Frame
180 days
Title
mRS
Description
Score of 0-2
Time Frame
180 days
Title
EQ-5D
Description
Quality of life scale
Time Frame
180 days
Title
Change in the volume of ICH and ICH+IVH
Description
As measured by non-contrast CT of the head
Time Frame
Between baseline CT and 24-hour CT
Title
mRS
Description
Ordinal distribution
Time Frame
90 days
Title
EQ-5D
Description
Quality of life scale
Time Frame
90 days
Title
mRS
Description
Ordinal distribution
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, U.K., Japan) Exclusion Criteria: 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. Pre-existing disability (mRS > 2) Symptomatic thrombotic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction, pulmonary embolus, deep vein thrombosis, or unstable angina) Clinical or EKG evidence of ST elevation consistent with acute myocardial ischemia Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled) Refusal to participate in study by patient, legal representative, or family member Known or suspected thrombocytopenia (unless current platelet count documented above 50,000/μL) Unfractionated heparin use with abnormal PTT Pro-coagulant drugs within 24 hours prior to patient enrollment into the FASTEST trial (example, tranexamic acid or aminocaproic acid) Low-molecular weight heparin use within the previous 24 hours Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered 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 Planned withdrawal of care or comfort care measures Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism, drug dependency, or psychological disorder) Known or suspected allergy to trial medication(s), excipients, or related products Contraindications to study medication Previous participation in this trial (previously randomized) Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Broderick, MD
Phone
(513) 919-5404
Email
joseph.broderick@uc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
James Grotta, MD
Phone
(281) 387-2329
Email
james.c.grotta@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Broderick, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Liptrap, MD
Email
elizabethle@uabmc.edu
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Supreet Kaur, MD
Email
supreet.kaur@DignityHealth.org
Facility Name
Mills Peninsula Medical Center
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilana Spokoyny, MD
Email
spokoyi@sutterhealth.org
Facility Name
UCSD Health La Jolla
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brett Meyer, MD
Email
bcmeyer@health.ucsd.edu
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Navdeep S Sangha, MD
Email
navdeep.x.sangha@kp.org
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
May Nour, MD, PhD
Email
MNour@mednet.ucla.edu
Facility Name
UC Irvine Medical Center,
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Shah, MD
Email
jshah@uci.edu
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lara L Zimmermann, MD
Email
LLZimmermann@ucdavis.edu
Facility Name
UCSD Medical Center - Hillcrest Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brett Meyer, MD
Email
bcmeyer@health.ucsd.edu
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren K Ng, MD
Email
Ng.Lauren@mayo.edu
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Digvijaya Navalkele, MD, MPH
Email
digvijaya.navalkele@emory.edu
Facility Name
WellStar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raisa C. Martinez, MD
Email
Raisa.MartinezMartinez@wellstar.org
Facility Name
The Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chung-Huan Sun, MD
Email
chsun@queens.org
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Babak S. Jahromi, MD, PhD
Email
Babak.Jahromi@nm.org
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Mansour, MD
Email
ali.mansour@uchospitals.edu
Facility Name
Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harish N. Showkeen, MD
Email
harish_shownkeen@cdh.org
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Borczuk, MD
Email
Borczuk.Pierre@mgh.harvard.edu
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adalia H. Jun-O'Connell, MD
Email
Adalia.Jun@umassmemorial.org
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher A Lewandowski, MD
Email
CLEWAND1@hfhs.org
Facility Name
M Health Fairview Ridges Hospital,
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Streib, MD
Email
streib@umn.edu
Facility Name
M Health Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Streib, MD
Email
cdstreib@umn.edu
Facility Name
M Health Fairview St. John's Hospital
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Streib, MD
Email
streib@umn.edu
Facility Name
M Health Fairview University of Minnesota Medical Center Hospital,
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Streib, MD
Email
streib@umn.edu
Facility Name
Mayo Clinic Saint Marys Campus
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugene L. Scharf, M.D.
Email
scharf.eugene@mayo.edu
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael E Brogan, MD
Email
Michael.E.Brogan@HealthPartners.Com
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter D Panagos, MD
Email
panagospd@wustl.edu
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John W Liang, MD
Email
john.liang@mountsinai.org
Facility Name
The Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Liang, MD
Email
John.Liang@mountsinai.org
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Mathew, DO
Email
Jason.Mathew@stonybrookmedicine.edu
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustapha A Ezzeddine, MD
Email
Mustapha.Ezzeddine@wakehealth.edu
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyle Walsh, MD
Email
walshk4@ucmail.uc.edu
Facility Name
OSU Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yousef Hannawi, MD
Email
Yousef.Hannawi@osumc.edu
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William J Hicks, MD
Email
william.hicks@ohiohealth.com
Facility Name
Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mouhammad Jumaa, MD
Email
Mouhammad.JumaaMD@ProMedica.org
Facility Name
St. John Medical Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Errol L Gordon, MD
Email
Errol.gordon@ascension.org
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ted J Lowenkopf, MD
Email
Theodore.Lowenkopf@providence.org
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina T Gentile, MD
Email
ngentile@temple.edu
Facility Name
Medical University of South Carolina University Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Holmstedt, MD
Email
holmsted@musc.edu
Facility Name
Memorial Hermann Memorial City Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ritvij Bowry, MD
Email
Ritvij.Bowry@uth.tmc.edu
Facility Name
Memorial Hermann-Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Grotta, MD
Email
james.c.grotta@uth.tmc.edu
Facility Name
University of Utah Healthcare
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramesh Grandhi, MD, MS
Email
ramesh.grandhi@hsc.utah.edu
Facility Name
VCU Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis J. Rivet, MD
Email
dennis.rivet@vcuhealth.org
Facility Name
University of Calgary - Foothills Medical Centre
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew M Demchuk, MD, PhD
Email
ademchuk@ucalgary.ca
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
AB T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian H. Buck, MD, FRCPC
Email
bbuck@ualberta.ca
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Yin Dominic TSE, MD
Email
dominic.tse@vch.ca
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashkan Shoamanesh, MD
Email
ashkan.shoamanesh@phri.ca
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dar Dowlatshahi, MD
Email
ddowlat@toh.ca
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Houman Khosravani, MD PhD FRCPC
Email
Houman.Khosravani@sunnybrook.ca
Facility Name
University Hospital Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan C Purrucker, MD
Email
jan.purrucker@med.uni-heidelberg.de
Facility Name
Clinic Frankfurt Hoechst
City
Frankfurt
State/Province
Hessen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thorsten Steiner, MD
Email
thorsten.steiner@icloud.com
Facility Name
University Hospital Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hauke Schneider, Dr. med.
Email
hauke.schneider@uk-augsburg.de
Facility Name
Charite University Medicine Berlin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Nolte, MD
Email
christian.nolte@charite.de
Facility Name
University Hospital Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Poli, Dr. med.
Email
sven.poli@uni-tuebingen.de
Facility Name
National Cerebral and Cardiovascular Center
City
Suita
State/Province
Osaka
ZIP/Postal Code
564-8565
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazunori Toyoda, MD,PhD,FAHA
Email
toyoda@ncvc.go.jp
Facility Name
Kyushu Medical Center
City
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasushi Okada, MD
Email
okada.yasushi.yh@mail.hosp.go.jp
Facility Name
Gifu University Hospital
City
Gifu
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toru Iwama, MD
Email
tiwama@gifu-u.ac.jp
Facility Name
Kagoshima City Hospital
City
Kagoshima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fumio Miyashita, MD
Email
fu-miya@xc4.so-net.ne.jp
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nobuyuki Sakai, MD
Email
n.sakai@siren.ocn.ne.jp
Facility Name
Japanese Red Cross Kyoto Daini Hospital
City
Kyoto
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshinari Nagakane, MD
Email
ynagakane@gmail.com
Facility Name
Iwate Prefectural Central Hospital
City
Morioka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naoto Kimura, MD
Email
kmr@themis.ocn.ne.jp
Facility Name
Niigata City General Hospital
City
Niigata
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenichi Morita, MD, PhD
Email
kmt@bri.niigata-u.ac.jp
Facility Name
KMU University Hospital
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yusuke Yakushiji, MD
Email
yakushiy@hirakata.kmu.ac.jp
Facility Name
NHO Osaka National Hospital
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshiyuki Fujinaka, MD
Email
fujinaka@nsurg.med.osaka-u.ac.jp
Facility Name
Nakamura Memorial Hospital
City
Sapporo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenji Kamiyama, MD
Email
ikamirin911@med.nmh.or.jp
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigeru Fujimoto, MD, PhD
Email
shigeruf830@jichi.ac.jp
Facility Name
Kyorin University Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teruyuki Hirano, MD, PhD
Email
terry@ks.kyorin-u.ac.jp
Facility Name
Toranomon Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takayuki Hara, MD
Email
thara@toranomon.gr.jp
Facility Name
Vall d'Hebron University Hospital (VHUH)
City
Horta
State/Province
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos A. Molina, MD, PhD
Email
cmolina@vhebron.net
Facility Name
Bellvitge University Hospital,
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pere Cardona Portela, MD
Email
pcardonap@bellvitgehospital.cat
Facility Name
Santa Creu and Sant Pau Hospital
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Martí-Fàbregas, MD,PhD
Email
jmarti@santpau.cat
Facility Name
Girona University Hospital
City
Girona
State/Province
Catalonia
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yolanda Silva Blas, MD, PhD
Email
ysilva.girona.ics@gencat.cat
Facility Name
John Radcliffe Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Mathieson, MD
Email
Phil.Mathieson@ouh.nhs.uk
Facility Name
Royal Stoke University Hospital
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Indira Natarajan, FRCP, MSc
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tudor Gheorghiu, MD
Email
tudor.gheorghiu1@nhs.net
Facility Name
Queens Medical Centre
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ganesh Subramanian, MB, FRCP, M Ed, M Res
Email
Ganesh.subramanian@nuh.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
34427473
Citation
Naidech AM, Grotta J, Elm J, Janis S, Dowlatshahi D, Toyoda K, Steiner T, Mayer SA, Khanolkar P, Denlinger J, Audebert HJ, Molina C, Khatri P, Sprigg N, Vagal A, Broderick JP. Recombinant factor VIIa for hemorrhagic stroke treatment at earliest possible time (FASTEST): Protocol for a phase III, double-blind, randomized, placebo-controlled trial. Int J Stroke. 2022 Aug;17(7):806-809. doi: 10.1177/17474930211042700. Epub 2021 Sep 5.
Results Reference
derived

Learn more about this trial

Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

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