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

Bayer

Status: Completed

Conditions: Non-valvular Atrial Fibrillation (NVAF)

Treatments: Drug: Rivaroxaban (Xarelto_ BAY59-7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT01598051

16296

Details and patient eligibility

About

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.

Enrollment: 741 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

741 participants in 1 patient group

Group 1

Description:

Patients treated with Xarelto under practical manner for SPAF.

Treatment:

Drug: Rivaroxaban (Xarelto_ BAY59-7939)