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

Bayer741 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

741

Conditions

Non-valvular Atrial Fibrillation (NVAF)

Interventions

Rivaroxaban (Xarelto_ BAY59-7939)DRUG

Patients treated with Xarelto under practical manner for SPAF.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Multiple Locations, Japan

Outcomes

Primary Outcomes

Improvement of treatment satisfaction (Evaluated through ACTS and TSQM questionnaires)

Time frame: Up to 6 months

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

Incidence of events of stroke

Time frame: Up to 6 months

Incidence of events of non-central nervous system embolism

Time frame: Up to 6 months

Data from ClinicalTrials.gov

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