Trial Condition(s):

Atrial Fibrillation

Belgian real life non-interventional study (NIS) on Xarelto in non-valvular Atrial Fibrillation (AF) patients treated for the prevention of stroke and systemic embolism (BOX-AF)

Bayer Identifier:

16851

ClinicalTrials.gov Identifier:

NCT01855139

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with non-valvular AF treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.

Inclusion Criteria
- Adult patients ≥ 18 years old with a confirmed diagnosis of non-valvular atrial fibrillation
 - Patients must in addition present with at least one of following risk factors:
 -- prior stroke, TIA (transient ischemic attack) or non-CNS (central nervous system) systemic embolism
 -- left ventricular ejection fraction of < 40%
 -- symptomatic heart failure, New York Heart Association class 2 or higher
 -- age ≥75 years
 -- age ≥65 years in combination with either diabetes, coronary disease or arterial hypertension
Exclusion Criteria
- Patients who do not fulfil the Belgian reimbursement criteria

Trial Summary

Enrollment Goal
106
Trial Dates
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Phase
N/A
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, Belgium

Status
Completed
 

Trial Design