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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rivaroxaban

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

15 mg OD or 20 mg OD

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

15 mg OD or 20 mg OD

Intervention Type DRUG

Eligibility Criteria

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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