Recombinant Factor VIIa for Hemorrhagic Stroke

(FASTEST Part 2 Trial)

This trial seeks an effective treatment for acute spontaneous intracerebral hemorrhage (ICH), a type of stroke caused by sudden brain bleeding. Researchers are testing recombinant Factor VIIa, administered through an IV injection, to determine if it can stop the bleeding and improve recovery when given within 120 minutes of the stroke. Participants may receive either the drug or a placebo (inactive substance) for comparison. The trial seeks individuals who have experienced a spontaneous ICH and can receive treatment quickly after symptoms start, particularly those with a positive spot sign on a CT scan, indicating ongoing bleeding. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

The trial does not specify if you need to stop all current medications, but you cannot participate if you've used certain blood thinners or pro-coagulant drugs recently. It's best to discuss your specific medications with the trial team.

Research has shown that recombinant Factor VIIa (rFVIIa) has been studied for treating brain bleeding after a stroke. In earlier studies, administering rFVIIa within four hours of stroke symptoms reduced the size of brain bleeds, known as hematomas. However, it did not completely stop the bleeding in every case.

One study examined serious issues like heart attacks or new strokes that could result from clots. Although these issues were closely monitored, they were not common according to the study. It is important to note that the FDA has already approved recombinant Factor VIIa for other uses, indicating a known safety profile.

Recombinant Factor VIIa is unique because it targets hemorrhagic stroke by promoting blood clotting quickly, potentially reducing bleeding in the brain. Unlike standard treatments like supportive care and blood pressure management, which are more about stabilizing a patient, rFVIIa directly addresses the bleeding by enhancing the body's natural clotting process. Researchers are excited about this treatment because it can be administered as an intravenous injection within 120 minutes of stroke onset, offering a rapid response and potentially improving outcomes significantly faster than current options.

Research has shown that recombinant Factor VIIa (rFVIIa), which participants in this trial may receive, can help reduce the size of a hematoma—a blood collection outside blood vessels—in patients who have experienced a bleeding stroke. One study found that 36% of patients treated with rFVIIa had no increase in hematoma size after 24 hours, compared to 25% of those who received a placebo. However, while rFVIIa helps control bleeding, it has not consistently improved survival or overall recovery in past studies. The treatment appears most effective when administered early, within 120 minutes of stroke onset. Acting quickly is crucial for better outcomes, especially for certain patients identified by early scans.¹²⁴⁵⁶