Trial Condition(s):

Brain Ischemia

Xarelto [SPAF] post-marketing surveillance in Japan

Bayer Identifier:

15798

ClinicalTrials.gov Identifier:

NCT01582737

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
11310
Trial Dates
black-arrow
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
Active, not recruiting
 

Trial Design