Xarelto [SPAF] Post-marketing Surveillance in Japan
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|ClinicalTrials.gov Identifier: NCT01582737|
Recruitment Status : Active, not recruiting
First Posted : April 23, 2012
Last Update Posted : December 6, 2018
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.
|Condition or disease||Intervention/treatment|
|Brain Ischemia||Drug: Rivaroxaban(Xarelto, BAY59-7939)|
|Study Type :||Observational|
|Actual Enrollment :||11311 participants|
|Official Title:||Special Drug Use Investigation of Xarelto [SPAF]|
|Actual Study Start Date :||May 30, 2012|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||January 17, 2020|
Drug: Rivaroxaban(Xarelto, BAY59-7939)
Patients treated with Xarelto under practical manner for SPAF.
- Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin) [ Time Frame: Up to 2 years ]
- Incidence of events of stroke [ Time Frame: Up to 5 years ]
- Incidence of events of non-central nervous system embolism [ Time Frame: Up to 5 years ]
- Determination of patient's demography to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey [ Time Frame: Baseline ]
- Determination of patient's medical history to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey [ Time Frame: Baseline ]
- Determination of patient's background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582737
|Multiple Locations, Japan|
|Study Director:||Bayer Study Director||Bayer|