check_circleStudy Completed

Atrial fibrillation

Bayer Identifier:

16851

ClinicalTrials.gov Identifier:

NCT01855139

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - Patients who do not fulfil the Belgian reimbursement criteria

Trial summary

Enrollment Goal
106
Trial Dates
July 2013 - December 2014
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Belgium

Primary Outcome

  • Number of patients with major bleedings
    date_rangeTime Frame:
    1 year or 30 days after end of rivaroxaban
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients with symptomatic thromboembolic events
    date_rangeTime Frame:
    1 year or 30 days after end of rivaroxaban
    enhanced_encryption
    Safety Issue:
    Yes
  • All-cause mortality
    date_rangeTime Frame:
    1 year or 30 days after end of rivaroxaban
    enhanced_encryption
    Safety Issue:
    Yes
  • Adverse events
    date_rangeTime Frame:
    1 year or 30 days after end of rivaroxaban
    enhanced_encryption
    Safety Issue:
    Yes
  • Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)
    date_rangeTime Frame:
    1 year or 30 days after end of rivaroxaban
    enhanced_encryption
    Safety Issue:
    No
  • Quantities of resource use consumption
    date_rangeTime Frame:
    1 year or 30 days after end of rivaroxaban
    enhanced_encryption
    Safety Issue:
    No

Trial design

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)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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