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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study Design

Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : July 2013
Primary Completion Date : October 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ambulatory or hospitalized patients coming from the cardiology clinic of the participating hospitals
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855139


Locations
Belgium
Many locations, Belgium
Sponsors and Collaborators
Bayer
Janssen Scientific Affairs, LLC
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01855139     History of Changes
Other Study ID Numbers: 16851
XA1313BE ( Other Identifier: Company internal )
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by Bayer:
Non-valvular atrial fibrillation
Stroke
Systemic embolism
Oral anticoagulation
Real-life setting
Preventive measure

Additional relevant MeSH terms:
Atrial Fibrillation
Embolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants