November 16, 2011 – Johnson & Johnson Pharmaceutical Research & Development announced that adding oral rivaroxaban to standard antiplatelet therapy significantly reduced the composite primary efficacy endpoint of cardiovascular-related deaths, heart attacks or strokes in patients with acute coronary syndrome (ACS) compared to those receiving standard therapy alone. Results from the pivotal Phase 3 ATLAS ACS 2 TIMI 51 trial presented at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine also showed that rivaroxaban significantly increased rates of major bleeding, but did not create an excess risk of fatal bleeding over standard therapy alone.
