Bayer HealthCare announced today the initiation of the PIONEER AF-PCI study, a Phase IIIb clinical study of its oral anticoagulant Xarelto® (rivaroxaban) to investigate how best to treat patients with non-valvular atrial fibrillation (AF) who undergo percutaneous coronary intervention (PCI) with stent placement.
The PIONEER AF-PCI study will enrol approximately 2,100 patients worldwide. The trial will assess the safety of two rivaroxaban treatment strategies and a dose-adjusted vitamin K antagonist (VKA) treatment strategy. Patients will be treated for 12 months.
“There are limited data available on how best to treat those patients with atrial fibrillation who require anticoagulant therapy for stroke prevention and also have a coronary stent implanted requiring dual antiplatelet therapy,” said C. Michael Gibson, MS, MD, Chairman of the PERFUSE Study Group, Harvard Medical School, and the Principal Investigator of the PIONEER AF-PCI study. “This study will help to address a clinically important question and provide physicians with information needed to make treatment decisions for this high-risk patient population.”
“We heard the excitement from physicians when Xarelto was approved for use in patients with non-valvular atrial fibrillation and we also listened to the questions they asked us about what to do for patients with overlapping risk factors,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “The PIONEER AF-PCI study is part of our ongoing commitment to improve patient outcomes across a broad range of venous and arterial thromboembolic conditions.”
The PIONEER AF-PCI trial is part of the global clinical development program for rivaroxaban, which will – by the time of its completion – have involved more than 100,000 patients worldwide.