Xarelto [SPAF] Post-marketing Surveillance in Japan

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01582737
First received: April 20, 2012
Last updated: September 25, 2014
Last verified: September 2014

April 20, 2012
September 25, 2014
May 2012
March 2019   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01582737 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Xarelto [SPAF] Post-marketing Surveillance in Japan
Special Drug Use Investigation of Xarelto [SPAF]

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with non-valvular arterial fibrillation necessary for the treatment for prevention of ischemic stroke and systemic embolism

Brain Ischemia
Drug: Rivaroxaban(Xarelto, BAY59-7939)
Patients treated with Xarelto under practical manner for SPAF.
Group 1
Intervention: Drug: Rivaroxaban(Xarelto, BAY59-7939)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
January 2020
March 2019   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Japan
 
NCT01582737
15798, XAR-SPAF
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP