RT Journal Article
SR Electronic
T1 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
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e020286
DO 10.1136/bmjopen-2017-020286
VO 8
IS 6
A1 Yasuo Okumura
A1 Ikuo Fukuda
A1 Mashio Nakamura
A1 Norikazu Yamada
A1 Morimasa Takayama
A1 Hideaki Maeda
A1 Takeshi Yamashita
A1 Takanori Ikeda
A1 Makoto Mo
A1 Tsutomu Yamazaki
A1 Atsushi Hirayama
A1 ,
YR 2018
UL http://bmjopen.bmj.com/content/8/6/e020286.abstract
AB 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.