Multicenter, Open-Label, Randomized Controlled Trial of Warfarin and Edoxaban Tosilate Hydrate for the Treatment of Deep Vein Thrombosis in Persons with Severe Motor Intellectual Disabilities

Abstract

Sudden death in patients with severe motor and intellectual disabilities (SMID) is sometimes caused in part by pulmonary thromboembolism (PTE), and deep venous thrombosis (DVT) has drawn attention as a possible embolic source. Warfarin, which is a conventional therapeutic agent, is not easy to control appropriately, and daily management can be especially difficult in SMID patients. On the other hand, edoxaban tosilate hydrate, which has been newly approved for insurance coverage for the treatment of DVT, is not listed in the Guidelines for the Diagnosis, Treatment and Prevention of Pulmonary Thromboembolism and Deep Vein Thrombosis (DVT-PTE guidelines). The aim of this study is to evaluate the efficacy and safety of anticoagulation therapy (warfarin vs. edoxaban) in DVT treatment in SMID patients by means of an open-label, randomized controlled trial. The primary endpoint is the incidence of hemorrhagic events during 12 months of follow up.

Deep Vein Thrombosis in Severe Motor and Intellectual Disabilities Patients and Its Treatment by Anticoagulants of Warfarin Versus Edoxaban

“…We previously reported that the incidence of DVT was high in these patients. 10,13) In the present study, the frequency of DVT in SMID patients was investigated using lower extremity venous ultrasound. SMID patients with DVT, for whom no treatment method has been established, were administered an oral anticoagulant, warfarin, the standard treatment, or edoxaban tosilate hydrate (LIXIANA ® ), a non-vitamin K-inhibitory oral anticoagulant (NOAC) newly developed as a substitute for warfarin that is covered by national health insurance, and their efficacies and safeties were evaluated.…”

“…The National Hospital Organization Central Research Ethics Committee approved the study, and the protocol was registered in the UMIN Clinical Trial Registry (UMIN000024736). 10) All patients provided written informed consent, and the study was conducted in accordance with the Declaration of Helsinki and Ethical Guidelines for Medical and Health Research Involving Human Subjects.…”