Trial Condition(s):

Non-valvular Atrial fibrillation (NVAF)

Xarelto [SPAF-QOL] post-marketing surveillance in Japan

Bayer Identifier:

16296

ClinicalTrials.gov Identifier:

NCT01598051

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
741
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Japan

Status
Completed
 

Trial Design