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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Janssen Scientific Affairs, LLC
• Treatments: Rivaroxaban

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