Xarelto [SPAF] Post-marketing Surveillance in Japan

Conditions

Brain Ischemia

Keywords

Xarelto, SPAF

Brief summary

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF. The objective of this study is to assess safety and effectiveness of Xarelto using in real clinical practice. A total of 10,000 patients are to be enrolled and assessed in 2 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.

Takanori Ikeda, Satoshi Ogawa, Takanari Kitazono, Jyoji Nakagawara, Kazuo Minematsu et al. (13 authors)

Journal of Thrombosis and Thrombolysis2019-08-2052 citations

10.1007/s11239-019-01934-6

Real-world outcomes of rivaroxaban treatment in patients with nonvalvular atrial fibrillation and worsening renal function.

Nakagawara J, Ikeda T, Ogawa S, Kitazono T, Minematsu K, Miyamoto S, Murakawa Y, Takeichi M, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S.

2019-07-293 citations

10.1016/j.jjcc.2019.06.003

Real-world outcomes of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS).

Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Minematsu K, Miyamoto S, Murakawa Y, Takeichi M, Ohashi Y, Okayama Y, Sunaya T, Yamanaka S.

2019-02-0824 citations

10.1016/j.jjcc.2019.01.001

Real-World Outcomes of Rivaroxaban Treatment in Patients with Both Nonvalvular Atrial Fibrillation and a History of Ischemic Stroke/Transient Ischemic Attack

Kazuo Minematsu, Takanori Ikeda, Satoshi Ogawa, Takanari Kitazono, Jyoji Nakagawara et al. (13 authors)

Cerebrovascular Diseases2019-01-015 citations

10.1159/000502883

Design and baseline characteristics of the Xarelto Post‐Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (<scp>XAPASS</scp>)

Satoshi Ogawa, Kazuo Minematsu, Takanori Ikeda, Takanari Kitazono, Jyoji Nakagawara et al. (12 authors)

Journal of Arrhythmia2018-02-0716 citations

10.1002/joa3.12034

Interventions

DRUGRivaroxaban(Xarelto, BAY59-7939)

Patients treated with Xarelto under practical manner

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Patients with non-valvular atrial fibrillation (NVAF) for whom the decision to be treated with Xarelto was made * Patients without experience of using Xarelto prior to the study

Exclusion criteria

* Patients who are contraindicated based on the product label

Design outcomes

Primary

Measure	Time frame
Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin)	Up to 2 years
Incidence of events of stroke	Up to 5 years
Incidence of events of non-central nervous system embolism	Up to 5 years

Secondary

Measure	Time frame
Determination of patient's demography to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey	Baseline
Determination of patient's medical history to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey	Baseline
Determination of patient's background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey	Baseline

Countries

Japan

Outcome results

None listed