Bristol-Myers Squibb and Pfizer commence new safety trial of Eliquis

Bristol-Myers Squibb and Pfizer have commenced patient enrolment for AUGUSTUS, a phase IV trial that aims to provide further data on the safety performance of Eliquis.

The study will evaluate the safety of the novel oral anticoagulant versus warfarin or other vitamin K antagonists in patients with nonvalvular atrial fibrillation and a recent acute coronary syndrome, or who are undergoing percutaneous coronary intervention.

AUGUSTUS is anticipated to enroll 4,600 eligible patients from 30 countries, and aims to test two hypotheses in the study population – first, whether Eliquis is noninferior to vitamin K antagonists in terms of bleeding prevention, and second, whether the addition of aspirin to an anticoagulant and P2Y12 inhibitor results in more bleeding.

This is intended to be one of several new clinical trials that will help provide additional information on the safe and appropriate use of Eliquis for certain specific types of patients.

Principal investigator Dr Renato Lopes of the Duke Clinical Research Institute said: "Limited data are available to inform the use of Eliquis and other oral anticoagulants in nonvalvular atrial fibrillation patients who require concomitant dual antiplatelet therapy."

Eliquis was recommended for use in the prevention of blood clots by the National Institute for Health and Care Excellence earlier this year.