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| ID | Type | Description | Link |
|---|---|---|---|
| XAR-SPAF | Other Identifier | company internal |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Patients treated with Xarelto for the purpose of prevention of ischemic stroke and systemic embolism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban(Xarelto, BAY59-7939) | Drug | Patients treated with Xarelto under practical manner |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with non-valvular arterial fibrillation necessary for the treatment for prevention of ischemic stroke and systemic embolism
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31578012 | Derived | Minematsu K, Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Miyamoto S, Murakawa Y, Takeichi M, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S. Real-World Outcomes of Rivaroxaban Treatment in Patients with Both Nonvalvular Atrial Fibrillation and a History of Ischemic Stroke/Transient Ischemic Attack. Cerebrovasc Dis. 2019;48(1-2):53-60. doi: 10.1159/000502883. Epub 2019 Oct 2. | |
| 31432451 |
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| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Baseline |
| Determination of patient's background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey | Baseline |
| Derived |
| Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Minematsu K, Miyamoto S, Murakawa Y, Iwashiro S, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S. Outcomes associated with under-dosing of rivaroxaban for management of non-valvular atrial fibrillation in real-world Japanese clinical settings. J Thromb Thrombolysis. 2019 Nov;48(4):653-660. doi: 10.1007/s11239-019-01934-6. |
| 31371191 | Derived | 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. Real-world outcomes of rivaroxaban treatment in patients with nonvalvular atrial fibrillation and worsening renal function. J Cardiol. 2019 Dec;74(6):501-506. doi: 10.1016/j.jjcc.2019.06.003. Epub 2019 Jul 29. |
| 30745002 | Derived | Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Minematsu K, Miyamoto S, Murakawa Y, Takeichi M, Ohashi Y, Okayama Y, Sunaya T, Yamanaka S. Real-world outcomes of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS). J Cardiol. 2019 Jul;74(1):60-66. doi: 10.1016/j.jjcc.2019.01.001. Epub 2019 Feb 8. |
| 29657592 | Derived | Ogawa S, Minematsu K, Ikeda T, Kitazono T, Nakagawara J, Miyamoto S, Murakawa Y, Ohashi Y, Takeichi M, Okayama Y, Yamanaka S, Inuyama L. Design and baseline characteristics of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS). J Arrhythm. 2018 Feb 7;34(2):167-175. doi: 10.1002/joa3.12034. eCollection 2018 Apr. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |