Hokusai-VTE Phase 3 study, which enrolled more than 8,250 patients from more than 400 clinical sites, will compare Edoxaban 60mg once-daily to warfarin control therapy.
The double-dummy, event-driven, multi-national study design, which reflects clinical practice and provides a flexible treatment duration of three, six or 12 months, will allow investigators to assess patients with a range of risks, including patients with moderate or severe conditions of PE and DVT.
Hokusai-VTE steering committee chairman, the Academic Medical Center in Amsterdam department of vascular medicine chairman, internal medicine professor Harry Buller said Hokusai-VTE marks an important step in the development of the new class of oral anticoagulants, direct factor Xa inhibitors due to its design and large patient population.
"What sets the Hokusai-VTE study apart from other studies of its kind is that it aims to reflect clinical practice through the flexible treatment duration," Buller added.
Edoxaban is an investigational, once daily, novel oral factor Xa inhibitor licensed only in Japan for the prevention of VTE after major orthopaedic surgery, under the brand name Lixiana.