Daiichi Sankyo Company Limited announced the initiation of Hokusai-VTE Cancer, a multinational study which will investigate the efficacy and safety of edoxaban, an oral, once-daily selective factor Xa inhibitor, versus dalteparin for the treatment of VTE associated with cancer (other than basal-cell or squamous-cell carcinoma of the skin) for whom long-term treatment with a low molecular weight heparin (LMWH) is intended. The purpose of the study is to evaluate edoxaban in comparison with dalteparin in preventing the combined outcome of VTE recurrence or major bleeding following an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) event in patients with cancer. The recruitment has started, and approximately 1,000 patients are expected to be enrolled in the study at clinical sites across 13 countries.
Edoxaban is an oral, once-daily anticoagulant that specifically inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting.14 The global edoxaban clinical trial program included two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48, with nearly 30,000 patients combined. The results from these trials form the basis of regulatory filings for edoxaban for treatment and prevention of symptomatic VTE in patients with DVT and/or PE, and for the prevention of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF), respectively
