Xarelto [SPAF] Post-marketing Surveillance in Japan

Bayer

Status: Completed

Conditions: Brain Ischemia

Treatments: Drug: Rivaroxaban(Xarelto, BAY59-7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT01582737

15798

XAR-SPAF (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 11,310 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 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

Trial design

11,310 participants in 1 patient group

Group 1

Description:

Patients treated with Xarelto for the purpose of prevention of ischemic stroke and systemic embolism

Treatment:

Drug: Rivaroxaban(Xarelto, BAY59-7939)