Trial Condition(s):
Atrial Fibrillation
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)
Bayer Identifier:
16851
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, Belgium | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Number of patients with major bleedingsTimeframe: 1 year or 30 days after end of rivaroxaban
- Number of patients with symptomatic thromboembolic eventsTimeframe: 1 year or 30 days after end of rivaroxaban
- All-cause mortalityTimeframe: 1 year or 30 days after end of rivaroxaban
- Adverse eventsTimeframe: 1 year or 30 days after end of rivaroxaban
- Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)Timeframe: 1 year or 30 days after end of rivaroxaban
- Quantities of resource use consumptionTimeframe: 1 year or 30 days after end of rivaroxaban
Additional Information
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