Janssen, Bayer, Put Early Halt to Study Evaluating Efficacy, Safety of Xarelto

RARITAN, NJ — Janssen Research & Development LLC and Bayer have stopped on the basis of “futility” a study evaluating the efficacy and safety of Xarelto (rivaroxaban) for the secondary prevention of stroke and systemic embolism in patients with a recent embolic stroke of undetermined source (ESUS).

In an Oct. 5 announcement, the companies explained that the study, if it were to be completed, is “unlikely” to show the benefit of rivaroxaban versus aspirin.

“The trial showed comparable efficacy between rivaroxaban and the standard of care, aspirin, and little chance of rivaroxaban showing an overall benefit versus aspirin if the …