Real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with rivaroxaban vs. vitamin k antagonists (RELOAD)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01AA04) phenprocoumon

  phenprocoumon

  (B01AF01) rivaroxaban

  rivaroxaban
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Patients, newly initiated with Rivaroxaban or Phenprocoumon with an non-valvular atrial fibrillation (NVAF) diagnosis from January 1, 2012 through December 31, 2015.
• 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:
  99999

Study design details

• Main study objective:
  The main objective of this study is to assess the riskof ischemic stroke (effectiveness) and intracranialhemorrhage (ICH, safety) in patients treated withRivaroxaban compared to patients treated with Phenprocoumon
• Outcomes:
  - Risk of ischemic stroke - Risk of intracranial hemorrhage (ICH), - Risk of ischemic stroke or ICH- Risk of systemic embolism (SE)- Risk of transient ischemic attack (TIA)- Risk of ischemic stroke or SE or TIA For more details please visit www.clinicaltrials.gov
• Data analysis plan:
  Time-to-event analyses using unadjusted and adjusted multivariate cox proportional hazard models and a 1:1 propensity score matched analyses will be conducted to estimate Hazard Ratios and corresponding confidence intervals.