Xarelto [SPAF] Post-marketing Surveillance in Japan

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: April 20, 2012
Last updated: November 13, 2015
Last verified: November 2015

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 Intervention
Brain Ischemia
Drug: Rivaroxaban(Xarelto, BAY59-7939)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of Xarelto [SPAF]

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Incidence of events of stroke [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of events of non-central nervous system embolism [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determination of patient's demography to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Determination of patient's background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 11311
Study Start Date: May 2012
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Rivaroxaban(Xarelto, BAY59-7939)
Patients treated with Xarelto under practical manner for SPAF.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-valvular arterial fibrillation necessary for the treatment for prevention of ischemic stroke and systemic embolism

Inclusion Criteria:

  • Patients who received Xarelto for SPAF
  • Patients without experience of using Xarelto prior to the study.

Exclusion Criteria:

  • Patients who are contraindicated based on the product label
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01582737

Many Locations, Japan
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01582737     History of Changes
Other Study ID Numbers: 15798, XAR-SPAF
Study First Received: April 20, 2012
Last Updated: November 13, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:

Additional relevant MeSH terms:
Brain Ischemia
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2015