Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Non-interventional study

Non-interventional study design

Case-control
Study drug and medical condition

Medical condition to be studied

Ischaemic stroke
Haemorrhagic stroke
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)

Estimated number of subjects

132000
Study design details

Main study objective

To assess the association between stroke and exposure to different pharmacological groups and active principles

Outcomes

Demographic and anthropometric characteristics (age, sex, geographic distribution, MEDEA index, physical activity and BMI), toxic habits (smoking, alcohol), medical history (hypertension, diabetes, cardiovascular, cerebrovascular and peripheral vascular disease, osteoarthritis, inflammatory arthritis, dementia, bipolar disorder, depression/anxiety, chronic obstructive pulmonary disease, etc.), Charlson index, frequenting primary care (number of visits in the last year) and the number of prescriptions (active on index date), laboratory parameters (lipid profile, glycaemia and glycated hemoglobin, uric acid, glomerular filtration rate last predetermination to the index date), cardiovascular risk assessment and drug exposure.

Data analysis plan

We will analyze stroke risk associated with exposure to drugs adjusted by risk factors (age, sex, and other variable tha are shown associated with the disease and possibly the exhibition of the population) by logistic regression .We plan to conduct a subanalysis in populations with osteoarthritis and dementia.Associations will be expressed as odds ratio estimates and confidence intervals of 95%.