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

Conditions

Deep Vein Thrombosis and Pulmonary Embolism

Shohei Migita, Yasuo Okumura, Ikuo Fukuda, Mashio Nakamura, Norikazu Yamada et al. (12 authors)

Frontiers in Cardiovascular Medicine2023-02-092 citations

10.3389/fcvm.2023.1074661

Effectiveness and safety of rivaroxaban in patients with venous thromboembolism and active cancer: A subanalysis of the J'xactly study.

Hisatake S, Ikeda T, Fukuda I, Nakamura M, Yamada N, Takayama M, Maeda H, Yamashita T, Mo M, Yamazaki T, Okumura Y, Hirayama A, J'xactly Investigators.

2022-11-15

10.1016/j.jjcc.2022.11.007

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 et al. (11 authors)

BMJ Open2018-06-0116 citations

10.1136/bmjopen-2017-020286

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients 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

Exclusion criteria

Exclusion criteria: 1. 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

Design outcomes

Primary

Measure	Time frame
Recurrence/exacerbation of symptomatic venous thromboembolism (VTE)	—

Secondary

Measure	Time frame
? 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	—

Measure

Time frame

? 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

—

Countries

Japan

Outcome results