Recombinant factor VIIa versus placebo for spontaneous intracerebral haemorrhage within 2 h of symptom onset (FASTEST): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial - Pub

3 months ago

Recombinant factor VIIa was tested against placebo in a phase 3 trial (FASTEST) for spontaneous intracerebral haemorrhage (ICH) within 2 hours of symptom onset.
The study involved 626 participants across 93 sites in multiple countries, with a mean age of 61 years and a mean time to treatment of 100 minutes.
Primary outcome was functional status at 180 days measured by modified Rankin Scale (mRS), showing no significant difference between the intervention and placebo groups.
Recombinant factor VIIa reduced haematoma growth (-3.7 mL for ICH, -5.2 mL for ICH plus IVH) but did not improve functional outcomes.
Increased risk of life-threatening thromboembolic events was observed in the intervention group (3.41 relative risk).
The trial was stopped early for futility based on interim analyses.
Funding was provided by the National Institute of Neurological Diseases and Stroke, Japan Agency for Medical Research and Development, and Novo Nordisk.

Hasty Briefsbeta