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)

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)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Belgium
  • Many locations, Belgium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rivaroxaban	Drug: Rivaroxaban (Xarelto, BAY59-7939); 15 mg OD or 20 mg OD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Scientific Affairs, LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 14, 2013
• First Posted (Estimate): May 16, 2013

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 17, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Stroke; Non-valvular atrial fibrillation; Systemic embolism; Oral anticoagulation; Real-life setting; Preventive measure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Embolism; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 16851; XA1313BE (Other Identifier: Company internal)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No