EMIT-AF/VTE Registry Initiated to Evaluate Daiichi Sankyo's Lixiana
December 13, 2016—Daiichi Sankyo Europe GmbH announced that the first patient has been enrolled in the EMIT-AF/VTE registry, which will collect real-world clinical data on the use of the company's once-daily Lixiana (edoxaban) with regard to diagnostic and interventional procedures in patients with nonvalvular atrial fibrillation (NVAF) or venous thromboembolism (VTE).
The EMIT-AF/VTE registry is a real-world, multinational, multicenter, prospective, observational, noninterventional study that will include approximately 2,000 patients over 2.5 years.
According to the company, data will be collected from patients treated with edoxaban for 2,000 planned or unplanned procedures across 500 sites, including hospitals and office-based sites, in Belgium, France, Germany, Italy, The Netherlands, Spain, and the United Kingdom. Daiichi Sankyo is also reviewing options to expand the EMIT-AF/VTE registry to clinical sites beyond Europe.
Patients will be enrolled from primary and secondary care settings, as well as other specialty settings, to collect data on the usage pattern of edoxaban in the context of diagnostic or interventional procedures in unselected patients with NVAF or VTE.
The study will document the periprocedural management of edoxaban and collect data on safety and other outcomes. Additional objectives include assessing efficacy outcomes as a composite of major cardiovascular events and collecting details on the types of diagnostic or therapeutic procedures. The primary safety outcome is the rate of major bleeding (within 30 days postintervention) using the International Society on Thrombosis and Hemostasis definition.
Edoxaban is an oral, once-daily, direct factor Xa inhibitor that is currently marketed in Europe, the United States, Japan, South Korea, and Taiwan.
In Europe, edoxaban is approved for the prevention of stroke and systemic embolic events in adult patients with NVAF with one or more risk factors and for the treatment of deep vein thrombosis and pulmonary embolism and prevention of recurrent deep vein thrombosis and pulmonary embolism in adults.