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

Study identification

• EU PAS number:
  EUPAS29867
• Study ID:
  42008
• Official title and acronym:
  Non-Interventional, cross-sectional study to describe NOACs management in elderly patients with non-valvular atrial fibrillation (NVAF) in Spain. RE-BELD Study
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  This study has been designed in order to describe the current non-vitamin K antagonist oral anticoagulants (NOACs) management in elderly patients in Spain. It will be conducted in approximately 50 sites in Spain, by investigators from the following specialties: cardiologists, hematologists and geriatricians. It is planned to have a 9-month recruitment period from first site initiated, or until the sample size is achieved. Primary 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. Secondary objectives: 1. To describe patients characteristics at the time of the study visit by current NOAC type stratified by duration since first NOAC initiation. 2. To describe OAC treatment management since first NOAC initiation until the study visit by duration since first NOAC initiation: previous vitamin K antagonists (VKA) treatment, first NOAC treatment duration, NOAC dose changes, switch between NOACs and reasons for switch, total NOAC treatment duration and additional antiplatelet treatment. 3. To describe the Clinical Frailty Scale grading, CFS, at the time of the study visit, by current NOAC type. 4. To describe first NOAC usage by NOAC type, for primary prevention or secondary prevention, at the time of first NOAC initiation. Further objective: To evaluate the appropriateness of prescribed therapy based on Spanish health authorities recommendations (therapeutic positioning report) and other regional guidelines by NOAC type (if there are enough patients for a NOAC type), at the time of first NOAC initiation. The design of the study impose a single visit to be performed for the informed consent signature and data collection that will coincide with one of those performed by the patients as part of the routine follow-up of their disease.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 50 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:09/05/2019

Actual:09/05/2019

Study start date

Planned:16/09/2019

Actual:09/09/2019

Data analysis start date

Planned:17/11/2020

Actual:23/11/2020

Date of final study report

Planned:16/07/2021

Actual:13/07/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim España, S.A.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable