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)

Tracking Information
First Submitted Date	May 14, 2013
First Posted Date	May 16, 2013
Last Update Posted Date	January 18, 2017
Study Start Date	July 2013
Actual Primary Completion Date	October 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: May 14, 2015)	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; (submitted: May 14, 2013)	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	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief 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
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)
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	Observational
Study Design	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	Atrial Fibrillation
Intervention	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	Completed
Actual Enrollment; (submitted: November 27, 2014)	106
Original Estimated Enrollment; (submitted: May 14, 2013)	150
Actual Study Completion Date	December 2014
Actual Primary Completion Date	October 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria	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	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Belgium
Removed Location Countries
Administrative Information
NCT Number	NCT01855139
Other Study ID Numbers	16851; XA1313BE ( Other Identifier: Company internal )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Bayer
Study Sponsor	Bayer
Collaborators	Janssen Scientific Affairs, LLC
Investigators	Study Director: Bayer Study Director Bayer
PRS Account	Bayer
Verification Date	January 2017