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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.
ClinicalTrials.gov Identifier: NCT01582737
Recruitment Status : Active, not recruiting
First Posted : April 23, 2012
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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)

Study Design

Study Type : Observational
Actual Enrollment : 11311 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 : March 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01582737


Locations
Japan
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01582737     History of Changes
Other Study ID Numbers: 15798
XAR-SPAF ( Other Identifier: company internal )
First Posted: April 23, 2012    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by Bayer:
Xarelto
SPAF

Additional relevant MeSH terms:
Ischemia
Brain Ischemia
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants