Xarelto Fails Phase III Trial.Bayer and Johnson & Johnson’s Janssen Research & Development have acknowledged that their Xarelto® (rivaroxaban) has
failed a Phase III trial assessing the blockbuster anticoagulant in patients with a recent embolic stroke of undetermined source (ESUS).
The companies said the Phase III NAVIGATE ESUS
missed its primary efficacy endpoint of superiority over aspirin in reducing the risk of stroke (ischemic, hemorrhagic, and undefined stroke; transient ischemic attack with positive neuroimaging) and systemic embolism.
NAVIGATE ESUS
was halted early at the recommendation of the study’s Independent Data Monitoring Committee, after a planned interim analysis showed comparable efficacy between patients treated with Xarelto and those treated with aspirin for secondary prevention of stroke and systemic embolism.
The study’s primary safety endpoint was major bleeding according to the criteria of the International Society on Thrombosis and Haemostasis. Bleeding rates were “very low overall and within the expected range,” Janssen said, though both companies acknowledged that
increased bleeding was observed in the rivaroxaban arm compared to the low-dose aspirin arm.Δεν είναι ορατοί οι σύνδεσμοι (links).
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