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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: October 17, 2016
Last verified: October 2016
  Purpose

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.


Condition Intervention
Brain Ischemia
Drug: Rivaroxaban (Xarelto_ BAY59-7939)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Treatment Satisfaction Under Rivaroxaban (ACTS/TSQM)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 741
Study Start Date: May 2012
Estimated Study Completion Date: January 2020
Primary Completion Date: June 2016 (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

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-valvular atrial fibrillation necessary for the treatment for prevention of ischemic stroke and systemic embolism
Criteria

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
  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: NCT01598051

Locations
Japan
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01598051     History of Changes
Other Study ID Numbers: 16296 
Study First Received: April 20, 2012
Last Updated: October 17, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Xarelto
SPAF
QOL

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

ClinicalTrials.gov processed this record on December 06, 2016