Non-interventional, cross-sectional study to describe NOACs management in patients with non-valvular atrial fibrillation (NVAF) in Spain. RE-CONOCE study (RE-CONOCE 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:
  Patients, mainly from the hospital setting, were included in the study if all of the following criteria were met:; 1. The patient was willing and provided written informed consent to participate in this study; 2. The patient was at least 18 years of age; 3. The patient had a diagnosis of non-valvular atrial fibrillation (NVAF); 4. The patient was on treatment with NOAC according to its approved local Summary of Product Characteristics (SmPC) and had initiated his first NOAC starting from November 2016
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Atrial fibrillation patients
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The primary objective of the study is to describe the usage of NOACs in patients with NVAF, in the hospital setting, based on the baseline characteristics at the time of first NOAC initiation.
• Outcomes:
  The primary outcome is the usage of NOACs, in patients with NVAF, in the hospital setting, based on the baseline characteristics at the time of first NOAC initiation. Baseline (at time of first NOAC initiation) variables will be analysed descriptively by NOAC type. Treatment groups will be defined according to first NOAC prescribed. The time frame for assessing this outcome is 7 months. - Appropriateness of NOAC prescription based on national recommendations (positioning therapeutic report) is planned.- NOAC treatment management.- Patient’s knowledge about his condition.
• Data analysis plan:
  Analyses will be performed by Boehringer Ingelheim’s designees. The analysis population will consist of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). If patients have missing values for an outcome, those patients will be excluded for that outcome’s analysis.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.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 andinterquartile ranges), absolute and relative frequencies, and ranges.