Non-Interventional, cross-sectional study to describe NOACs management in elderly patients with non-valvular atrial fibrillation (NVAF) in Spain. RE-BELD Study

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Elderly patients (≥75 years-old) with non-valvular atrial fibrillation (NVAF) at the time of the study visit.
• Age groups:
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Non-valvular atrial fibrillation (NVAF) patients
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  To describe the pattern of usage of NOACs prescribed according to their Summary of Product Characteristics (SmPC), by current NOAC type and dose, in elderly patients (≥75 years-old) with non-valvular atrial fibrillation (NVAF) at the time of the study visit.
• Outcomes:
  The primary outcome is the pattern of usage of non-vitamin K oral anticoagulants (NOACs) prescribed according to their Summary of Product Characteristics (SmPC), based on the percentage of patients by NOAC type and dose the patient is taking at the time of the study visit. Timeframe to complete data collection for this outcome is one day, the study visit day. Patient’s characteristics at the time of the study visit (by NOAC type) that the patient is taking at the time of the study visit. OAC treatment management (since first NOAC initiation until the study visit date). Clinical Frailty Scale grading (time of the study visit) by current NOAC type. First NOAC usage by NOAC type, for primary or secondary prevention, at time of first NOAC initiation
• Data analysis plan:
  Analyses will be performed by Boehringer Ingelheim’s designees. In this non-interventional study, retrospective data from medical charts and data at the study visit will be collected for non-valvular AF patients. Once the study has been completed and all data from the last patient have been recorded, the database will be closed and statistical analysis will be performed. The proposed methods for statistical analysis presented below are a summary of the methods that will be applied in the study to analyze the data collected and to answer the study objectives. Since the study is descriptive, the variables included in the study objectives will be summarized overall and by factors of interest. All results will be summarized with measures of central tendency (mean and median), variability/dispersion (standard deviation and interquartile ranges), absolute and relative frequencies, and ranges. A Statistical Analysis Plan will be prepared.