NCT07227246 Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2
| NCT ID | NCT07227246 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Joseph Broderick, MD |
| Condition | Intracerebral Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 350 participants in total. It began in 2025-05-06 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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 -
Contact & Investigator
Joseph P Broderick
PRINCIPAL INVESTIGATOR
University of Cincinnati
Frequently Asked Questions
Who can join the NCT07227246 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Intracerebral Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07227246 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 350 participants.
Is NCT07227246 currently recruiting?
Yes, NCT07227246 is actively recruiting participants. Contact the research team at broderjp@ucmail.uc.edu for enrollment information.
Where is the NCT07227246 trial being conducted?
This trial is being conducted at Birmingham, United States, Baldwin Park, United States, Burlingame, United States, Downey, United States and 11 additional locations.
Who is sponsoring the NCT07227246 clinical trial?
NCT07227246 is sponsored by Joseph Broderick, MD. The principal investigator is Joseph P Broderick at University of Cincinnati. The trial plans to enroll 350 participants.