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RECRUITING

NCT07227246

PHASE3

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

Sponsor: Joseph Broderick, MD

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2025-05-06

Completion Date

2029-06

Last Updated

2026-01-27

Healthy Volunteers

Conditions

Intracerebral Hemorrhage

Interventions

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.

BIOLOGICAL

Biological/Vaccine: Placebo

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 -

Locations (90)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (90)