Study type

Study topic

Human medicinal product

Study topic, other

Drug interactions

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, other

Direct oral anticoagulants

Anatomical Therapeutic Chemical (ATC) code

(B01AE07) dabigatran etexilate
(B01AF) Direct factor Xa inhibitors

Medical condition to be studied

Atrial fibrillation
Population studied

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

Hepatic impaired
Renal impaired

Estimated number of subjects

20000
Study design details

Main study objective

To quantify the risk of the most relevant pharmacological interactions (pharmacokinetic or pharmacodynamic) with the Direct Oral Anticoagulants currently marketed in Catalonia and their clinical repercussions in the form of hemorrhagic or thrombotic events during 2014-2021.

Outcomes

Risk of haemorrhage/thromboembolic event while on Direct Oral Anticoagulants compare to risk of haemorrhage /thromboembolic event while on Direct Oral Anticoagulants and an interacting drug. Atrial fibrillation population adherence to Direct Oral Anticoagulants Risk of haemorrhage/ thromboembolic events in patients with good adherence to Direct Oral Anticoagulants

Data analysis plan

Poisson conditional models will be used to estimate the incidence rate ratio (IRR) of primary and secondary events between the risk period (interaction) and the control period (non-interaction). The models will be adjusted for confounding variables such as age, seasonality, comorbidity and other clinical or statistically relevant characteristics.