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"

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Ambulatory or hospitalized patients coming from the cardiology clinic of the participating hospitals

Outcomes

Type Measure Time Frame Safety Issue
Primary Real-life medical resource use consumption based on medical examination and patient diary cards Up to 1.5 years No
Primary Number of patients with major bleedings 1 year or 30 days after end of rivaroxaban Yes
Primary Number of patients with symptomatic thromboembolic events 1 year or 30 days after end of rivaroxaban Yes
Primary All-cause mortality 1 year or 30 days after end of rivaroxaban Yes
Primary Adverse events 1 year or 30 days after end of rivaroxaban Yes
Primary Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS) 1 year or 30 days after end of rivaroxaban No
Primary Quantities of resource use consumption 1 year or 30 days after end of rivaroxaban No

Sponsors