Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01855139
First received: May 14, 2013
Last updated: February 26, 2015
Last verified: February 2015

May 14, 2013
February 26, 2015
July 2013
October 2014   (final data collection date for primary outcome measure)
Real-life medical resource use consumption based on medical examination and patient diary cards [ Time Frame: Up to 1.5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01855139 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Atrial Fibrillation
Drug: Rivaroxaban (Xarelto, BAY59-7939)
15 mg OD or 20 mg OD
Rivaroxaban
Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
December 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01855139
16851, XA1313BE
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2015

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