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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01855139

Acronym

BOX-AF

Enrollment

106

Registered

2013-05-16

Start date

2013-07-31

Completion date

2014-12-31

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Non-valvular atrial fibrillation, Stroke, Systemic embolism, Oral anticoagulation, Real-life setting, Preventive measure

Brief summary

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.

Interventions

DRUGRivaroxaban (Xarelto, BAY59-7939)

15 mg OD or 20 mg OD

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of patients with major bleedings	1 year or 30 days after end of rivaroxaban
Number of patients with symptomatic thromboembolic events	1 year or 30 days after end of rivaroxaban
All-cause mortality	1 year or 30 days after end of rivaroxaban
Adverse events	1 year or 30 days after end of rivaroxaban
Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)	1 year or 30 days after end of rivaroxaban
Quantities of resource use consumption	1 year or 30 days after end of rivaroxaban

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026