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

NCT01598051 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 741

Last updated 2019-05-30

No results posted yet for this study

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.

Conditions

  • Non-valvular Atrial Fibrillation (NVAF)

Interventions

DRUG

Rivaroxaban (Xarelto_ BAY59-7939)

Patients treated with Xarelto under practical manner for SPAF.

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-06-09
Completion
2017-03-31

Countries

  • Japan

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01598051 on ClinicalTrials.gov