Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2
NCT ID: NCT07227246
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
350 participants
INTERVENTIONAL
2025-05-06
2029-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Recombinant Factor VIIa
rFVIIa given as IV injection over 2 minutes within 120 minutes of stroke onset
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 angiography and be treated within 120 minutes of onset. 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.
Placebo
Placebo given as IV injection over 2 minutes within 120 minutes of stroke onset
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 angiography and be treated within 120 minutes or onset. 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.
Interventions
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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 angiography and be treated within 120 minutes of onset. 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/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 angiography and be treated within 120 minutes or onset. 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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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
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 -
18 Years
80 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Japan Agency for Medical Research and Development
OTHER_GOV
Novo Nordisk A/S
INDUSTRY
Joseph Broderick, MD
OTHER
Responsible Party
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Joseph Broderick, MD
Professor
Principal Investigators
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Joseph P Broderick
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Alabama Hospital
Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Kaiser Permanente Baldwin Park Medical Center
Baldwin Park, California, United States
Mills Peninsula Medical Center
Burlingame, California, United States
Kaiser Permanente Downey Medical Center
Downey, California, United States
Kaiser Permanente Fontana Medical Center
Fontana, California, United States
Kaiser Permanente South Bay Medical Center
Harbor City, California, United States
UCSD Health La Jolla
La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Kaiser Permanente West Los Angeles Medical Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UC Irvine Medical Center,
Orange, California, United States
Kaiser Permanente Riverside Medical Center
Riverside, California, United States
UC Davis Medical Center
Sacramento, California, United States
UCSD Medical Center - Hillcrest Hospital
San Diego, California, United States
San Francisco General Hospital
San Francisco, California, United States
UF Health Shands Hospital
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
WellStar Kennestone Hospital
Marietta, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Central DuPage Hospital
Winfield, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
M Health Fairview Ridges Hospital,
Burnsville, Minnesota, United States
M Health Fairview Southdale Hospital
Edina, Minnesota, United States
M Health Fairview St. John's Hospital
Maplewood, Minnesota, United States
M Health Fairview University of Minnesota Medical Center Hospital,
Minneapolis, Minnesota, United States
Mayo Clinic Saint Marys Campus
Rochester, Minnesota, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
North Shore University Hospital
Manhasset, New York, United States
Mount Sinai West
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
St. John Medical Center
Tulsa, Oklahoma, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina University Hospital
Charleston, South Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States
Memorial Hermann-Texas Medical Center
Houston, Texas, United States
University of Utah Healthcare
Salt Lake City, Utah, United States
VCU Medical Center
Richmond, Virginia, United States
University of Calgary - Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
St. Michaels Hospital
Toronto, Ontario, Canada
University of Montreal Hospital
Montreal, Quebec, Canada
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
University Hospital Erlangen
Erlangen, Bavaria, Germany
Clinic Frankfurt Hoechst
Frankfurt am Main, Hesse, Germany
University Hospital Augsburg
Augsburg, , Germany
Charite University Medicine Berlin
Berlin, , Germany
University Medical Center Hamburg
Hamburg, , Germany
University Hospital Tuebingen
Tübingen, , Germany
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan
Kyushu Medical Center
Fukuoka, , Japan
Gifu University Hospital
Gifu, , Japan
Kagoshima City Hospital
Kagoshima, , Japan
Kobe City Medical Center General Hospital
Kobe, , Japan
Japanese Red Cross Kyoto Daini Hospital
Kyoto, , Japan
Iwate Prefectural Central Hospital
Morioka, , Japan
Niigata City General Hospital
Niigata, , Japan
KMU University Hospital
Osaka, , Japan
NHO Osaka National Hospital
Osaka, , Japan
Nakamura Memorial Hospital
Sapporo, , Japan
Jichi Medical University Hospital
Shimotsuke, , Japan
Kyorin University Hospital
Tokyo, , Japan
Toranomon Hospital
Tokyo, , Japan
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Vall d'Hebron University Hospital (VHUH)
Horta, Barcelona, Spain
Bellvitge University Hospital,
L'Hospitalet de Llobregat, Barcelona, Spain
Santa Creu and Sant Pau Hospital
Barcelona, Catalonia, Spain
Girona University Hospital
Girona, Catalonia, Spain
Arnau de Vilanova University Hospital
Lleida, Catalonia, Spain
Valladolid University Hospital
Valladolid, , Spain
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Queens Medical Centre
Nottingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Elizabeth Liptrap, MD
Role: primary
Supreet Kaur, MD
Role: primary
Navdeep Sangha, MD
Role: primary
Ilana Spokoyny, MD
Role: primary
Navdeep Sangha, MD
Role: primary
Navdeep Sangha, MD
Role: primary
Navdeep Sangha, MD
Role: primary
Brett Meyer, MD
Role: primary
Navdeep S Sangha, MD
Role: primary
Navdeep Sangha, MD
Role: primary
May Nour, MD, PhD
Role: primary
Jay Shah, MD
Role: primary
Navdeep S Sangha, MD
Role: primary
Lara L Zimmermann, MD
Role: primary
Brett Meyer, MD
Role: primary
Vineeta Singh, MD
Role: primary
Anna Y Khanna, MD
Role: primary
Lauren K Ng, MD
Role: primary
Digvijaya Navalkele, MD, MPH
Role: primary
Raisa C. Martinez, MD
Role: primary
Chung-Huan Sun, MD
Role: primary
Babak S. Jahromi, MD, PhD
Role: primary
Ali Mansour, MD
Role: primary
Harish N. Showkeen, MD
Role: primary
Pierre Borczuk, MD
Role: primary
Adalia H. Jun-O'Connell, MD
Role: primary
Christopher A Lewandowski, MD
Role: primary
Christopher Streib, MD
Role: primary
Christopher Streib, MD
Role: primary
Christopher Streib, MD
Role: primary
Christopher Streib, MD
Role: primary
Eugene L. Scharf, M.D.
Role: primary
Peter D Panagos, MD
Role: primary
Richard Elias Temes, MD
Role: primary
John W Liang, MD
Role: primary
John Liang, MD
Role: primary
Jason Mathew, DO
Role: primary
Kyle Walsh, MD
Role: primary
Yousef Hannawi, MD
Role: primary
William J Hicks, MD
Role: primary
Errol L Gordon, MD
Role: primary
Ted J Lowenkopf, MD
Role: primary
Nina T Gentile, MD
Role: primary
Christine Holmstedt, MD
Role: primary
Sanjeev Sivakumar, MD
Role: primary
Ritvij Bowry, MD
Role: primary
James Grotta, MD
Role: primary
Ramesh Grandhi, MD, MS
Role: primary
Dennis J. Rivet, MD
Role: primary
Andrew M Demchuk, MD, PhD
Role: primary
Brian H. Buck, MD, FRCPC
Role: primary
Ming Yin Dominic TSE, MD
Role: primary
Nishita Singh, MD, DM, MSc
Role: primary
Ashkan Shoamanesh, MD
Role: primary
Dar Dowlatshahi, MD
Role: primary
Houman Khosravani, MD PhD FRCPC
Role: primary
Alexandra Muccilli, MD
Role: primary
Laura C Gioia, MD, MSc
Role: primary
Jan C Purrucker, MD
Role: primary
Stefan T Gerner, MD
Role: primary
Thorsten Steiner, MD
Role: primary
Hauke Schneider, Dr. med.
Role: primary
Christian Nolte, MD
Role: primary
Götz Thomalla, MD
Role: primary
Sven Poli, Dr. med.
Role: primary
Kazunori Toyoda, MD,PhD,FAHA
Role: primary
Yasushi Okada, MD
Role: primary
Toru Iwama, MD
Role: primary
Fumio Miyashita, MD
Role: primary
Nobuyuki Sakai, MD
Role: primary
Yoshinari Nagakane, MD
Role: primary
Naoto Kimura, MD
Role: primary
Kenichi Morita, MD, PhD
Role: primary
Yusuke Yakushiji, MD
Role: primary
Toshiyuki Fujinaka, MD
Role: primary
Kenji Kamiyama, MD
Role: primary
Shigeru Fujimoto, MD, PhD
Role: primary
Teruyuki Hirano, MD, PhD
Role: primary
Takayuki Hara, MD
Role: primary
Alejandro Bustamante Rangel, MD
Role: primary
Carlos A. Molina, MD, PhD
Role: primary
Pere Cardona Portela, MD
Role: primary
Joan Martí-Fàbregas, MD,PhD
Role: primary
Yolanda Silva Blas, MD, PhD
Role: primary
Francisco Purroy Garcia, MD PhD
Role: primary
Juan F Arenillas Lara, MD
Role: primary
Philip Mathieson, MD
Role: primary
Indira Natarajan, FRCP, MSc
Role: primary
Tudor Gheorghiu, MD
Role: primary
Ganesh Subramanian, MB, FRCP, M Ed, M Res
Role: primary
Related Links
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Related Info
Other Identifiers
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Ucincinnatifastestpart2
Identifier Type: -
Identifier Source: org_study_id