Northwell Health will conduct a NIH-funded study assessing the effects of the experimental drug in treating patients with ICH.
A new multi-center, randomized, phase 3 study will assess the effects of experimental drug recombinant Factor Vlla (rFVllA) on intracerebral hemorrhage (ICH).1
The study, “Recombinant Factor Vlla (rFVlla) for Acute Hemorrhagic Stroke Administered at Earliest Time,” also called FASTEST, is funded by the National Institutes of Health (NIH) and will be conducted at North Shore University Hospital by Northwell Health’s Institute for Neurology and Neurosurgery and The Feinstein Institutes for Medical Research.
“ICH occurs when a diseased blood vessel within the brain bursts, allowing blood to leak inside the brain causing an increase in pressure,” said principal investigator Richard Temes, MD, director, Center for Neurocritical Care, Northwell Health, in a statement. “The sudden increase in pressure can cause damage to brain cells. Our hope is that rFVlla, if administered within two hours of onset in appropriately selected patients with spontaneous ICH, results in decreased bleeding as compared to placebo. The findings of the FASTEST study will help us better determine if rFVlla improves outcome for stroke patients.”
The study will enroll adults between the ages of 18 and 80 years with ICH. rFVllA will be administered within 2 hours of stroke onset. Patients may be enrolled without consent if unconscious and a family member or other representative is not readily available, as ICH requires immediate treatment. Every attempt will be made to locate family to give consent.
Before the study commences, Northwell must engage in community outreach efforts to provide information, answer questions, and get community members’ input about the clinical research, as a requirement of being a participating site of NIH research.
“The FASTEST trial is another example of our commitment to advance acute hemorrhagic stroke treatments into clinical practice and improve outcomes for stroke patients,” said Kevin J. Tracey, MD, president and CEO, Feinstein Institutes.
ICH is the deadliest type of stroke, accounting for more than 10% of the estimated 17 million worldwide strokes per year with a mortality rate of over 40%. There are no effective, approved treatments for ICH. Ongoing research continues to attempt to fill this void, despite setbacks. The recent phase 2 STOP-AUST trial (NCT01702636) revealed that tranexamic acid does not prevent ICH growth, although the treatment was safe with no increases in thromboembolic complications.2
Principal investigator Atte Meretoja, MD, PhD, MSc, FRACP, director, Helsinki University Central Hospital, and colleagues found that 26 (52%) patients in the placebo group and 22 (44%) in the tranexamic acid group experienced ICH growth at 24 hours (odds ratio [OR], 0.72; 95% CI, 0.32–1.59; P = 0.41). Adjusting for time from onset to therapy in addition to baseline volume also failed to yield significant benefit (OR, 0.72; 95% CI, 0.32–1.59; P = .43).
At 3 months, the distribution of functional outcome did not fulfil the proportional odds assumptions, and the assumption-free analysis showed no difference between the treatment groups (generalized OR, 1.01; 95% CI 0.63–1.61; P = .97). “Because hemorrhage growth is a major cause of morbidity and mortality in acute ICH, new, safe, and effective treatments to stem ongoing hemorrhage are urgently required.” Meretoja et al concluded.