Relationship of Advanced Holding Education and ADherence on antithrombotic in younger NVAF patients (ReAHEAD)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Evaluation of additional patient educationa compared with regular clinical practice
• Data collection methods:
  Primary data collection

Study drug and medical condition

• Medicinal product name:
  PRADAXA
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AE07) dabigatran etexilate

  dabigatran etexilate
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Age groups:
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Estimated number of subjects:
  1200

Study design details

• Study design:
  This was a multi-center, 1:1 randomized study to evaluate the effects of educational intervention on adherence to dabigatran, for up to 12 months. Adult patients newly diagnosed with AF within 1 month, under 75 years old, ; and newly prescribed with dabigatran on physician’s decision per local lab.
• Main study objective:
  The study aims to explore whether the advanced educational intervention would improve the adherence to dabigatran.
• Setting:
  The study was carried out from 2020 to 2023 at around 23 hospitals, where AF patients were mainly treated in Taiwan. The first patient to be enrolled was from 21-Sep-2020, and the last patient’s last visit was on 26-Jun-2023. ; A total of 897 patients were screened and signed the ICF, and 873 patients were eligible to be enrolled in the analysis.
• Outcomes:
  The primary objective of this study is to explore whether the advanced educational intervention would improve the adherence to dabigatran, in a 12-month follow-up period for newly diagnosed atrial fibrillation (AF) adult patients under 75 years old. The secondary objectives are to investigate comorbidities, CHA2DS2-VASc score, and further endpoints in dabigatran patients (with or without advanced educational intervention) in a 12-month follow-up period for AF adult patients under 75 years old.
• Data analysis plan:
  The analyses will be mainly descriptive. All patients who have signed the informed consent and fulfilled study criteria will be included in the main analysis. The primary analysis will describe the proportion of patients with high adherence to dabigatran treatment at 12 months for each group. Subjects without MMAS-8 value recorded at 12 months will be excluded from the analysis of primary endpoint.Continuous variables will be reported as number, mean, standard deviation (SD), minimum, maximum, and 95% confidence interval (CI). Categorical variables will be summarized as number and frequency or percentage with observed (non-missing) data. For endpoints to be compared between patients with and without advanced educational intervention, the analyses will be done by t-test or Wilcoxon rank-sum test for continuous data, and by Chi-square, Fisher’s exact, or other appropriate tests for categorical data. Other endpoints will be analyzed in an exploratory manner.