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Completed

NCT Number: NCT01598051

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

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.

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Key information

Conditions

Non-valvular Atrial Fibrillation (NVAF)

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto_ BAY59-7939)

Drug

Patients treated with Xarelto under practical manner for SPAF.

Primary outcomes

  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

Other outcomes

  1. Treatment satisfaction scores at Month 3 and Month 6 by demographic and clinical characteristics

    Time frame: At Month 3 and Month 6

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Official study title

Treatment Satisfaction Under Rivaroxaban (ACTS/TSQM)

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
May 15, 2012
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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