Bristol-Myers Squibb and Pfizer begin Phase IV clinical trial of Eliquis

10th September 2015 (Last Updated September 10th, 2015 18:30)

Bristol-Myers Squibb and Pfizer have started the Phase four clinical trial, Augustus, with the enrolment of the first patient.

Bristol-Myers Squibb and Pfizer have started the Phase four clinical trial, Augustus, with the enrolment of the first patient.

As part of the trial, participants with nonvalvular atrial fibrillation (NVAF) and a recent acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI) will receive P2Y12 inhibitor in combination with Eliquis or other vitamin K antagonists (VKA).

Participants will also be randomised to aspirin or placebo. Eliquis has been approved to reduce the risk of stroke and systemic embolism in patients with NVAF.

Approximately 4,600 patients from 30 countries are expected to take part in Augustus, which will test two hypotheses in the study population.

"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."

In an open-label manner, it will initially evaluate whether Eliquis is non-inferior or not to a VKA on the combined outcome of major bleeding and clinically relevant non-major (CRNM) bleeding.

In double-blind scenario, the study will test whether the addition of aspirin to an anticoagulant and P2Y12 inhibitor leads to major and CRNM bleeding.

Duke Clinical Research Institute (DCRI) clinical events classification director and AUGUSTUS principle investigator 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."

The clinical trial will also compare Eliquis to VKA (with concomitant P2Y12 therapy) for CRNM bleeding, death, stroke, myocardial infarction, stent thrombosis, urgent revascularization, or re-hospitalisation.

A P2Y12 inhibitor and aspirin with a P2Y12 inhibitor alone with either Eliquis or VKA will also be evaluated with respect to death, stroke, myocardial infarction, stent thrombosis, or urgent revascularization and re-hospitalisation.