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

Atrial Fibrillation Clinical Trial

— BOX-AF  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855139
• Other study ID #: 16851
• Secondary ID: XA1313BE
• Status: Completed
• Phase: N/A
• First received: May 14, 2013
• Last updated: January 17, 2017
• Start date: July 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
15 mg OD or 20 mg OD

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with major bleedings		1 year or 30 days after end of rivaroxaban
Primary	Number of patients with symptomatic thromboembolic events		1 year or 30 days after end of rivaroxaban
Primary	All-cause mortality		1 year or 30 days after end of rivaroxaban
Primary	Adverse events		1 year or 30 days after end of rivaroxaban
Primary	Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)		1 year or 30 days after end of rivaroxaban
Primary	Quantities of resource use consumption		1 year or 30 days after end of rivaroxaban

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