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
| Autor: | Yukihiro Koretsune, Masayuki Kawasaki, Naoyuki Tanuma, Hideo Kaneko, Masao Kumode, Mashio Nakamura, Akiko Saito, Keiko Maruhashi, Akiko Kada, Noboru Takizawa, Tomoe Shinagawa, Michiko Inoue, Ryo Sumimoto, Shinjiro Akaboshi, Hiroshi Fujita, Takeshi Miyanomae, Hiroaki Murata, Nozomi Sano, Akiko Okumura, Sui Sone, Akiko Wakisaka, Hidekazu Taniguchi, Yoshitami Sanayama, Hiromitsu Ohmori, Tomoki Takechi |
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| Rok vydání: | 2018 |
| Předmět: |
Pediatrics
medicine.medical_specialty Time Factors Pyridines Deep vein Intelligence Motor Disorders Persons with Mental Disabilities Hemorrhage Motor Activity 030204 cardiovascular system & hematology Sudden death law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Japan Randomized controlled trial Edoxaban law Intellectual Disability medicine Clinical endpoint Humans Multicenter Studies as Topic cardiovascular diseases 030212 general & internal medicine Randomized Controlled Trials as Topic Venous Thrombosis business.industry Warfarin Anticoagulants General Medicine medicine.disease Thrombosis Thiazoles Venous thrombosis Treatment Outcome medicine.anatomical_structure chemistry business Factor Xa Inhibitors medicine.drug |
| Zdroj: | The Kurume Medical Journal. 65:11-16 |
| ISSN: | 1881-2090 0023-5679 |
| DOI: | 10.2739/kurumemedj.ms651003 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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