Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Xarelto [SPAF-QOL] Post-marketing Surveillance in Japan

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01598051
First received: April 20, 2012
Last updated: July 18, 2016
Last verified: July 2016

April 20, 2012
July 18, 2016
May 2012
June 2016   (final data collection date for primary outcome measure)
  • Improvement of treatment satisfaction (Evaluated through ACTS and TSQM questionnaires) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • 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 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of events of stroke [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of events of non-central nervous system embolism [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01598051 on ClinicalTrials.gov Archive Site
  • Determination of patient's demography which might affect the QOL, safety and efficacy of Xarelto using ACTS and TSQM questionnaires [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Determination of patient's medical history which might affect the QOL, safety and efficacy of Xarelto using ACTS and TSQM questionnaires [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Determination of patient's background which might affect the QOL, safety and efficacy of Xarelto using ACTS and TSQM questionnaires [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Xarelto [SPAF-QOL] Post-marketing Surveillance in Japan
Treatment Satisfaction Under Rivaroxaban (ACTS/TSQM)

The objective of this study is to understand if Rivaroxaban can improve treatment satisfaction of Warfarin patients and assess the safety and effectiveness of Xarelto in real clinical practice.

A total of 725 patients are to be enrolled and followed for a 6 months.period. QOL survey will be conducted at month 0, 3, 6 using ACTS/TSQM.

This study is categorized as a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with non-valvular atrial 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.
 
Active, not recruiting
741
January 2020
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients treated by Warfarin for their atrial fibrillation for at least two months at the time of the study initiation.
  • Rivaroxaban naïve patients
  • Patients 20 years old or older.
  • Patients who agree to sign the inform consent

Exclusion Criteria:

  • Patients who are contraindicated by product label
Both
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01598051
16296
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2016

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