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)
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ClinicalTrials.gov Identifier: NCT01855139 |
Recruitment Status
:
Completed
First Posted
: May 16, 2013
Last Update Posted
: January 18, 2017
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Sponsor:
Bayer
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Bayer
Tracking Information | ||||
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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 |
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Original Primary Outcome Measures |
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 |
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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 |
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Study Groups/Cohorts | Rivaroxaban
Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
106 | |||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 ) |
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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 |
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PRS Account | Bayer | |||
Verification Date | January 2017 |