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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Registration Number: NCT01855139
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-16
• Study Start: 2013-07
• Primary Completion: 2014-10
• Study Completion: 2014-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

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Exclusion Criteria

• Patients who do not fulfil the Belgian reimbursement criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban (Xarelto, BAY59-7939)	-

Primary Outcome Measures

Name	Time	Method
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