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

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ClinicalTrials.gov Identifier: NCT01598051
Recruitment Status : Active, not recruiting
First Posted : May 15, 2012
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Bayer

Brief Summary:

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 or disease Intervention/treatment
Brain Ischemia Drug: Rivaroxaban (Xarelto_ BAY59-7939)

Study Type : Observational
Actual Enrollment : 741 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Treatment Satisfaction Under Rivaroxaban (ACTS/TSQM)
Actual Study Start Date : May 31, 2012
Primary Completion Date : June 9, 2016
Estimated Study Completion Date : January 17, 2020

Resource links provided by the National Library of Medicine

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

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



Primary Outcome Measures :
  1. Improvement of treatment satisfaction (Evaluated through ACTS and TSQM questionnaires) [ Time Frame: Up to 6 months ]
  2. 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 ]
  3. Incidence of events of stroke [ Time Frame: Up to 6 months ]
  4. Incidence of events of non-central nervous system embolism [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. Determination of patient's demography which might affect the QOL, safety and efficacy of Xarelto using ACTS and TSQM questionnaires [ Time Frame: Baseline ]
  2. Determination of patient's medical history which might affect the QOL, safety and efficacy of Xarelto using ACTS and TSQM questionnaires [ Time Frame: Baseline ]
  3. Determination of patient's background which might affect the QOL, safety and efficacy of Xarelto using ACTS and TSQM questionnaires [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01598051


Locations
Japan
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Janssen Scientific Affairs, LLC
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01598051     History of Changes
Other Study ID Numbers: 16296
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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