ClinicaliQ Trial Snapshot
- Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial – Part 2 — Recruiting • Phase III • Cardiology / Cardiovascular • NCT07227246.
- What is being tested: Recombinant Factor VIIa (rFVIIa) as a potential therapeutic intervention to halt hematoma expansion and improve outcomes in patients with acute spontaneous intracerebral hemorrhage (ICH) when administered early in the clinical course.
- Patient eligibility overview: The trial focuses on acute ICH patients treated within an optimized early time window and specific patient subgroups identified as most likely to benefit from rFVIIa intervention, based on factors such as baseline hematoma volume and timing of presentation.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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…
Eligibility Snapshot
- : 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)
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.