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

Status: Completed

Conditions: Atrial Fibrillation

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01855139

XA1313BE (Other Identifier)

16851

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

106 participants in 1 patient group

Rivaroxaban

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)