Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

AMLODIPINE
RIVAROXABAN
PHENPROCOUMON

Medical condition to be studied

Atrial fibrillation
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

4000
Study design details

Main study objective

To evaluate the effectiveness (composite endpoint: prevention of ischemic stroke and systemic embolism) of rivaroxaban and amlodipine at the specified doses – compared to the dual therapy of phenprocoumon and amlodipine where amlodipine is being used for the treatment of hypertension in patients with NVAF.

Outcomes

Measuring the prevention of occurrence of the following events identified as hospitalisation for the composite endpoint of: • ischemic or undefined stroke /TIA, • systemic embolism (non?cerebrovascular embolism as retinal arterial occlusion, retinal vascular occlusion unspecified), The incidence rate of major bleeding as composite and single endpoints for the complete sample and subgroups of interest

Data analysis plan

The average treatment effect of phenprocoumon/amlodipine users on the risk of ischemic stroke and systemic embolism compared to rivaroxaban/amlodipine will be obtained from time-to-event analysis using an application of the extended (weighted) Cox model. The observed hazard ratios (HR) between comparator cohorts will be provided with 95% CIs.