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
  Purpose

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 ]

Estimated Enrollment: 10000
Study Start Date: May 2012
Estimated Study Completion Date: January 2020
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.

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582737

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Japan
Recruiting
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
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: September 25, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Xarelto
SPAF

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

ClinicalTrials.gov processed this record on October 22, 2014