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)

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: May 14, 2013
Last updated: December 14, 2015
Last verified: December 2015
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.

Condition Intervention
Atrial Fibrillation
Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of patients with major bleedings [ Time Frame: 1 year or 30 days after end of rivaroxaban ] [ Designated as safety issue: Yes ]
  • Number of patients with symptomatic thromboembolic events [ Time Frame: 1 year or 30 days after end of rivaroxaban ] [ Designated as safety issue: Yes ]
  • All-cause mortality [ Time Frame: 1 year or 30 days after end of rivaroxaban ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 1 year or 30 days after end of rivaroxaban ] [ Designated as safety issue: Yes ]
  • Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS) [ Time Frame: 1 year or 30 days after end of rivaroxaban ] [ Designated as safety issue: No ]
  • Quantities of resource use consumption [ Time Frame: 1 year or 30 days after end of rivaroxaban ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: July 2013
Study Completion Date: December 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rivaroxaban Drug: Rivaroxaban (Xarelto, BAY59-7939)
15 mg OD or 20 mg OD


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ambulatory or hospitalized patients coming from the cardiology clinic of the participating hospitals

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01855139

Many locations, Belgium
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01855139     History of Changes
Other Study ID Numbers: 16851  XA1313BE 
Study First Received: May 14, 2013
Last Updated: December 14, 2015
Health Authority: Belgium: Ethics Committee

Keywords provided by Bayer:
Non-valvular atrial fibrillation
Systemic embolism
Oral anticoagulation
Real-life setting
Preventive measure

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Embolism and Thrombosis
Heart Diseases
Pathologic Processes
Vascular Diseases
Enzyme Inhibitors
Factor Xa Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Serine Proteinase Inhibitors processed this record on May 23, 2016