Xarelto [SPAF] Post-marketing Surveillance in Japan

• Status: Completed
• Trial end date: 2020-01-17
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• PPatients with non-valvular atrial fibrillation (NVAF) for whom the decision to be treated with Xarelto was made

• Patients without experience of using Xarelto prior to the study

Exclusion Criteria:

• Patients who are contraindicated based on the product label