Design and rationale for the Japanese Registry of Rivaroxaban Effectiveness & Safety for the Prevention of Recurrence in Patients with Deep Vein Thrombosis and Pulmonary Embolism (J'xactly) study

Yasuo Okumura, Ikuo Fukuda, Mashio Nakamura, Norikazu Yamada, Morimasa Takayama, Hideaki Maeda, Takeshi Yamashita, Takanori Ikeda, Makoto Mo, Tsutomu Yamazaki, Atsushi Hirayama, J’xactly Investigators, Yasuo Okumura, Ikuo Fukuda, Mashio Nakamura, Norikazu Yamada, Morimasa Takayama, Hideaki Maeda, Takeshi Yamashita, Takanori Ikeda, Makoto Mo, Tsutomu Yamazaki, Atsushi Hirayama, J’xactly Investigators

Abstract

Introduction: Rivaroxaban, a factor Xa inhibitor used as a direct oral anticoagulant, is beneficial over warfarin in terms of food-drug interactions and the need for therapeutic monitoring in patients with acute venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism. Because there is little data regarding VTE treatment in Japan, a real-world survey of Japanese patients being treated with rivaroxaban for VTE is needed.

Methods and analysis: The Japanese Registry of Rivaroxaban Effectiveness & Safety for the Prevention of Recurrence in Patients with Deep Vein Thrombosis and Pulmonary Embolism has been established to investigate the clinical outcomes of rivaroxaban for the initial treatment and prevention of symptomatic recurrent VTE in Japanese patients with acute symptomatic/asymptomatic VTE. 150 institutions in Japan will enrol patients in the study; the target enrolment is 1000. All patients will be followed up two times a year for at least 18 months and up to 3 years after their enrolment. The primary outcome is symptomatic recurrent VTE occurring during the study period. The principal safety outcome is clinically relevant bleeding (ie, major bleeding or clinically relevant non-major bleeding) occurring during treatment. A clinical events committee will adjudicate all outcomes.

Ethics and dissemination: The study protocol has been approved by the Nihon University Itabashi Hospital, Clinical Research Ethics Committee and all local institutional ethics committees of the participating hospitals. Findings of the study will be presented in scientific sessions and will be published in peer-reviewed journals.

Trial registration number: NCT03091621,UMIN000025072; Pre-results.

Keywords: deep vein thrombosis; pulmonary embolism; real-world survey; rivaroxaban; venous thromboembolism.

Conflict of interest statement

Competing interests: AH reports grants from Bayer Pharmaceutical during the conduct of the study; grants and personal fees from Bayer Pharmaceutical, Daiichi-Sankyo Pharmaceutical , Astellas Pharma, Sanofi KK, Kyowa Hakko Kirin. Bristole-Myers Squibb Japan, personal fees from Sumitomo Dainippon Pharma , Astra Zeneka, Amgen Astellas BioPharma K.K., Eizai, MSD, Sanwa kagaku Kenkyusho, TAKEDA Pharmaceutical, Nippon Boehringer Ingelheim, Pfizer Japan, TOA EIYO, Janssen Pharmaceutical K.K., Actelion, Tanabe Mitsubishi Pharmaceutical,grants, personal fees and other from Otsuka Pharmaceutical,other from Boston Scientific Japan K.K., Japan Lifelin, Medtronic Japan, grants and other from St. Jude Medical Japan, grants from Abbott Vascular Japan, Nihon Medi-Physics. IF reports grants and personal fees from BayerYakuhin, Daiichi Sankyo, Pfizer Japan. MN reports personal fees from Daiichi Sankyo, Bayer Yakuhin, Pfizer Japan, Bristol-Myers Squibb K.K. NY reports personal fees from Bayer, Daiichi Sankyo, Pfizer, Bristol Myers. HM reports personal fees from Bayer Yakuhin, other from Yokohama courthouse. TY reports grants and personal fees from Bayer, grants and personal fees from Daiichi Sankyo, BMS, Mitsubishi Tanabe, personal fees from Pfizer, Eisai, Ono Pharmaceutical, Toa Eiyo, Nippon Boehringer. TI reports grants from Daiichi Sankyo, Bristol-Myers Squibb. MM reports personal fees from Bayer, Daichi-sankyo, Pfizer, Bristol -Myers Squibb. YO reports personal fees from Daiichi-Sankyo.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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