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)

This study has been completed.

Sponsor:

Collaborator:

Janssen Scientific Affairs, LLC

Information provided by (Responsible Party):

Bayer

ClinicalTrials.gov Identifier:

NCT01855139

First received: May 14, 2013

Last updated: January 17, 2017

Last verified: January 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

May 14, 2013

Last Updated Date

January 17, 2017

Start Date ^ICMJE

July 2013

Primary Completion Date

October 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of patients with major bleedings [ Time Frame: 1 year or 30 days after end of rivaroxaban ]
Number of patients with symptomatic thromboembolic events [ Time Frame: 1 year or 30 days after end of rivaroxaban ]
All-cause mortality [ Time Frame: 1 year or 30 days after end of rivaroxaban ]
Adverse events [ Time Frame: 1 year or 30 days after end of rivaroxaban ]
Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS) [ Time Frame: 1 year or 30 days after end of rivaroxaban ]
Quantities of resource use consumption [ Time Frame: 1 year or 30 days after end of rivaroxaban ]

Original Primary Outcome Measures ^ICMJE

Real-life medical resource use consumption based on medical examination and patient diary cards [ Time Frame: Up to 1.5 years ]

Change History

Complete list of historical versions of study NCT01855139 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Drug: Rivaroxaban (Xarelto, BAY59-7939)

15 mg OD or 20 mg OD

Study Groups/Cohorts

Rivaroxaban

Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

106

Completion Date

December 2014

Primary Completion Date

October 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01855139

Other Study ID Numbers ^ICMJE

16851
XA1313BE ( Other Identifier: Company internal )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Bayer

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Janssen Scientific Affairs, LLC

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

PRS Account

Bayer

Verification Date

January 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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