Daiichi Sankyo Company, Limited has announced that the first patient has been enrolled into the ENTRUST-AF PCI study. The multinational, randomized phase 3b study will evaluate a treatment regimen based on the company’s oral, once-daily direct factor Xa-inhibitor edoxaban (known by the brand name Lixiana outside the US and Savaysa in the US) against a vitamin K antagonist based regimen in patients with atrial fibrillation following successful percutaneous coronary intervention (PCI) with stent placement to investigate the incidence of major or clinically relevant non-major ISTH-defined bleeding (MCRB). 1,500 patients will be enrolled in ENTRUST-AF PCI from 200 clinical sites across Europe, Korea, Taiwan and the Ukraine.
“The optimal antithrombotic strategy for atrial fibrillation patients undergoing PCI with coronary stent implantation is unknown at this time,” said Pascal Vranckx, MD, clinical consultant in interventional cardiology and medical director of cardiac critical care services at the Hartcentrum Hasselt, Belgium. “The ENTRUST-AF PCI study will evaluate the role of edoxaban as part of a dual antithrombotic treatment strategy compared to a vitamin-K antagonist based antithrombotic strategy as recommended by current guidelines.”
“ENTRUST AF-PCI is an important study for atrial fibrillation patients undergoing PCI who require antiplatelet therapy and chronic edoxabanfor stroke prevention”, said Andreas Goette, MD, chief physician, St. Vincenz-Hospital Paderborn, Germany, Department of Cardiology and Intensive Care Medicine and principal study investigator. “In this study, edoxaban will be used with the approved dosage regimenfor stroke prevention in atrial fibrillation.”
“ENTRUST-AF PCI will add to the growing body of evidence in the Edoxaban Clinical Research Programme, and the results will advance clinicians’ understanding of the potential to reduce the risk of bleeding in atrial fibrillation patients undergoing PCI procedures,” said Hans Lanz, MD, executive director, global medical affairs, Daiichi Sankyo.
Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through our research programs evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in atrial fibrillation (AF) and venous thromboembolism (VTE). The edoxaban clinical research program includes multiple RCTs (randomized, controlled trials), registries and non-interventional studies, with the goal of generating new clinical and real-world-data regarding its use in AF and VTE populations. Daiichi Sankyo expects that more than 100,000 patients will participate in the edoxaban clinical research programme, including completed, ongoing and future research.
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets.