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 is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01855139
First received: May 14, 2013
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rivaroxaban Drug: Rivaroxaban (Xarelto, BAY59-7939)
15 mg OD or 20 mg OD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855139

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Belgium
Recruiting
Many locations, Belgium
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01855139     History of Changes
Other Study ID Numbers: 16851, XA1313BE
Study First Received: May 14, 2013
Last Updated: July 30, 2014
Health Authority: Belgium: Ethics Committee

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
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Rivaroxaban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014