COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Xarelto [SPAF] Post-marketing Surveillance in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01582737
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : February 5, 2020
Janssen Research & Development, LLC
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Brain Ischemia Drug: Rivaroxaban(Xarelto, BAY59-7939)

Layout table for study information
Study Type : Observational
Actual Enrollment : 11310 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of Xarelto [SPAF]
Actual Study Start Date : May 30, 2012
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : January 17, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Group/Cohort Intervention/treatment
Group 1 Drug: Rivaroxaban(Xarelto, BAY59-7939)
Patients treated with Xarelto under practical manner for SPAF.

Primary Outcome Measures :
  1. 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 ]
  2. Incidence of events of stroke [ Time Frame: Up to 5 years ]
  3. Incidence of events of non-central nervous system embolism [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Determination of patient's demography to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey [ Time Frame: Baseline ]
  2. 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 ]
  3. Determination of patient's background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey [ Time Frame: Baseline ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01582737

Layout table for location information
Multiple Locations, Japan
Sponsors and Collaborators
Janssen Research & Development, LLC
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Bayer Identifier: NCT01582737    
Other Study ID Numbers: 15798
XAR-SPAF ( Other Identifier: company internal )
First Posted: April 23, 2012    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Ischemia
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action