Overview

Xarelto [SPAF] Post-marketing Surveillance in Japan

Status:
Completed
Trial end date:
2020-01-17
Target enrollment:
Participant gender:
Summary
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF. The objective of this study is to assess safety and effectiveness of Xarelto using in real clinical practice. A total of 10,000 patients are to be enrolled and assessed in 2 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.
Details
Lead Sponsor:
Bayer
Collaborator:
Janssen Research & Development, LLC
Treatments:
Rivaroxaban