Contract Research & Services
Clinical Trials

Daiichi Sankyo initiates phase 3b study of Lixiana

Published 10 May 2017

Daiichi Sankyo announced the initiation of the ENVISAGE-TAVI AF study of Lixiana by enrolling the first patient in the trial.

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 LIXIANAKeytruda outside the US and SAVAYSAKeytruda in the US) against a vitamin K antagonist based regimen, with or without antiplatelet therapy, in patients with atrial fibrillation (AF) following successful transcatheter aortic valve implantation (TAVI).

The study will investigate the incidence of net adverse clinical events (NACE), including the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism (SEE), valve thrombosis, and major bleeding (International Society on Thrombosis and Haemostasis [ISTH] definition).

Approximately 1,400 patients will be enrolled in ENVISAGE-TAVI AF from 200 clinical sites across Europe, the United States and Canada.

George Dangas, MD, PhD, Professor of Medicine, Mount Sinai School of Medicine and co-principal study investigator, said: “ENVISAGE-TAVI AF is an important study because it will provide the first clinical evidence comparing the safety and efficacy of an edoxaban-based versus a VKA-based regimen in non-valvular AF patients with indication for chronic oral anticoagulation after successful TAVI in a sufficiently powered study. In this study, edoxaban will be used with the approved dosage regimenfor stroke prevention in atrial fibrillation."

Transcatheter aortic valve implantation (TAVI) has become an increasingly frequent procedure to treat aortic stenosis.

Aortic stenosis is a progressing disease, and may turn into a life threatening condition.3 In patients undergoing a TAVI procedure, AF is a frequent comorbidity which requires chronic oral anticoagulation therapy.

“At present, ENVISAGE-TAVI AF is the only study of patients undergoing TAVI designed to compare exclusively non-valvular AF patients on a novel oral anticoagulant regimen against a VKA-based regimen,” said Nicolas M. van Mieghem, MD, PhD, Erasmus University of Rotterdam and co-principal investigator.

“ENVISAGE-TAVI AF will add to the growing body of evidence in the Edoxaban Clinical Research Program, providing unique insights into the potential benefit of edoxaban in atrial fibrillation patients undergoing TAVI procedures, a high-risk population,” said Hans J. Lanz, MD, Executive Director, Global Medical Affairs, Daiichi Sankyo.

Source: Company Press Release