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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

741 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2017-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Non-valvular Atrial Fibrillation (NVAF)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients treated with Xarelto under practical manner for SPAF.

Rivaroxaban (Xarelto_ BAY59-7939)

Intervention Type DRUG

Patients treated with Xarelto under practical manner for SPAF.

Interventions

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Rivaroxaban (Xarelto_ BAY59-7939)

Patients treated with Xarelto under practical manner for SPAF.

Intervention Type DRUG

Eligibility Criteria

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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