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

Hiromitsu Ohmori, Mashio Nakamura, Akiko Kada, Akiko M. Saito, Yoshitami Sanayama, Tomoe Shinagawa, Hiroshi Fujita, Akiko Wakisaka, Keiko Maruhashi, Akiko Okumura, Noboru Takizawa, Hiroaki Murata, Michiko Inoue, Hideo Kaneko, Hidekazu Taniguchi, Masayuki Kawasaki, Nozomi Sano, Shinjiro Akaboshi, Naoyuki Tanuma, S. U.I. SoneMasao Kumode, Tomoki Takechi, Yukihiro Koretsune, R. Y.O. Sumimoto, Takeshi Miyanomae

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

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 anticoagula-tion 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.

Original languageEnglish
Pages (from-to)11-16
Number of pages6
JournalKurume Medical Journal
Volume65
Issue number1
DOIs
Publication statusPublished - 2018
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • General Medicine

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