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news.Bristol-Myers Squibb and Pfizer have enrolled first patient in Phase 4 clinical trial, dubbed Augustus, to evaluate safety of Eliquis (apixaban) in high risk patients.
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The trial will evaluate the safety of Eliquis in patients with nonvalvular atrial fibrillation (NVAF) with a recent acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI).
The companies expect to enroll 4,600 patients across 30 countries. The study is expected to be completed in September 2017.
All patients will receive a P2Y12 inhibitor in combination with Eliquis or a VKA. The study’s design is called a two-by-two factorial which includes the testing of two hypotheses in the study population.
It will initially evaluate whether or not Eliquis is noninferior to a VKA on the combined outcome of major bleeding and clinically relevant non-major (CRNM) bleeding when studied in an open-label manner.
In a double-blind manner, it will then identify whether or not the addition of aspirin to an anticoagulant and P2Y12 inhibitor results in more major and CRNM bleeding in the study population.
Duke Clinical Research Institute director of clinical events classification and principle investigator for Augustus Renato Lopes said: "Limited data are available to inform the use of Eliquis and other oral anticoagulants in NVAF patients who require concomitant dual antiplatelet therapy.
"With the first patient now enrolled in Augustus, we will be collecting data that will help inform the safety profile of Eliquis for NVAF patients who have suffered a recent ACS and/or are undergoing PCI."
Eliquis is an oral selective Factor Xa inhibitor. It lowers thrombin generation and blood clot formation.
It is approved for several indications in the US depending on efficacy and safety data from seven Phase 3 clinical trials.