Eliquis (apixaban) enters Phase IV trial in patients with nonvalvular atrial fibrillation following ACS or PCI- Pfizer + BMS

BMS and Pfizer Inc. announced that the first patient has been enrolled into the Phase IV clinical trial, AUGUSTUS. This two-by-two factorial, randomized controlled trial will evaluate the safety of Eliquis (apixaban) versus warfarin or other vitamin K antagonists (VKA) in patients with nonvalvular atrial fibrillation (NVAF) and a recent acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI), also known as a stent.

In addition, patients will also be randomized to aspirin or placebo. All patients will receive a P2Y12 inhibitor (such as clopidogrel) in combination with either Eliquis or a VKA. Eliquis is approved to reduce the risk of stroke and systemic embolism in patients with NVAF.