NIPH Clinical Trials Search

UMIN ID: UMIN000025072

Registered date:30/11/2016

Japanese registry of Rivaroxaban effectiveness & safety for the prevention of recurrence in patients with Deep Vein Thrombosis and Pulmonary Embolism

Basic Information

Recruitment status Open public recruiting
Health condition(s) or Problem(s) studiedDeep Vein Thrombosis and Pulmonary Embolism
Date of first enrollment2016/12/01
Target sample size1000
Countries of recruitmentJapan
Study typeObservational


Primary OutcomeRecurrence/exacerbation of symptomatic venous thromboembolism (VTE)
Secondary Outcome・ Onset/exacerbation of symptomatic pulmonary embolism (PE) ・ Onset/exacerbation of symptomatic deep vein thrombosis (DVT) ・ Major bleeding event (ISTH bleeding criteria) ・ Non-major bleeding event (bleeding events that do not correspond to major bleeding) ・ Recurrence/exacerbation of symptomatic venous thromboembolism or bleeding event during the initial strengthening treatment period ・ Acute coronary syndrome ・ Cerebral infarction ・ VTE related death ・ Cardiovascular death ・ All deaths ・ Relationship between change in D-dimer and recurrence ・ Comparison of examples of treatment continuation/discontinuation or termination events ・ Serious adverse events

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteriaPatients with symptomatic or asymptomatic venous thromboembolism prescribed rivaroxaban for the purpose of treatment and prevention of recurrence of acute deep vein thrombosis and pulmonary embolism
Exclude criteria1. Patients with a contraindication to rivaroxaban 2. Patients with chronic thromboembolic pulmonary hypertension (however, it is possible to register if there is coexisting acute pulmonary embolism or deep vein thrombosis) 3. Patients with active bleeding 4. In addition, patients determined to be inappropriate for the study by the attending doctor

Related Information


public contact
Name Yuki Nishiura
Address Toranomon Towers Office, 4-1-28 Toranomon, Minato-ku, Tokyo Japan
Telephone 0120-297-437
Affiliation Mebix, Inc. Research Promotion Group
scientific contact
Name Atsushi Hirayama
Address 30-1, Oyaguchikami-cho, Itabashi-ku, Tokyo Japan
Telephone 03-3972-8111
Affiliation Nihon University School of Medicine Division of Cardiology, Department of Internal Medicine