Bayer presents results of Xarelto trial at AHA

Germany's Bayer Schering Pharma presented findings from a Phase II study of the novel oral anticoagulant Xarelto (rivaroxaban) as a secondary prevention of acute coronary syndrome at the American Heart Association's meeting in New Orleans.

As a Phase II dose-finding study, the ATLAS ACS TIMI 46 trial was designed to test the safety and efficacy of rivaroxaban at escalating total daily doses, ranging from 5mg up to 20mg. Patients were then randomized to additionally receive either rivaroxaban or a placebo for six months. The primary efficacy endpoint was death, myocardiaI infarction, stroke or severe recurrent ischemia requiring revascularization. Rivaroxaban was associated with an observed 21% Relative Risk Reduction for the primary efficacy endpoint (p=0.1) and a statistically-significant 31% RRR against the secondary endpoint of death, MI, or stroke (p=0.028), demonstrating a consistent trend for efficacy across doses.

"Given the encouraging response rates we saw in the ATLAS ACS TIMI 46 trial, we feel very confident in the two doses selected for evaluation in the Phase III study," said Kemal Malik, head of global development. The Phase III ATLAS ACS TIMI 51 trial is planned to be initiated in December with a potential enrollment of up to 16,000 patients.