Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Case-control
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(B01AE) Direct thrombin inhibitors
Direct thrombin inhibitors

Medical condition to be studied

Ischaemic stroke
Haemorrhagic stroke
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

7950
Study design details

Main study objective

To assess the relative risk of stroke (ischaemic or haemorrhagic stroke) in patients with atrial fibrillation using dabigatran and in those using other new oral anticoagulant therapies (rivaroxaban, apixaban) as compared to the use of any vitamin K antagonist (VKA: fluindione, acenocoumarol or warfarin)

Outcomes

stroke (ischaemic or haemorrhagic stroke), Haemorrhage (major, leading to hospitalisation), or non-major i.e moderate (visit to a physician or emergency room and/or treatment required) or minor (others)

Data analysis plan

For the main analysis, conditional logistic regression will be used in order to be consistent with case-control matching. The model will include recent exposure to anticoagulant therapy (see below), past exposure to anticoagulant therapy including past switches or discontinuation in anticoagulant therapy, as well as risk factors for stroke, i.e. both a priori selected risk factors and a posteriori selected risk factors based on their association with stroke.