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
Drug utilisation
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

(B01AE07) dabigatran etexilate
dabigatran etexilate
(B01AF01) rivaroxaban
rivaroxaban
(B01AF02) apixaban
apixaban

Medical condition to be studied

Atrial fibrillation
Acute coronary syndrome
Population studied

Short description of the study population

Patients with Atrial fibrillation (AF) and Acute coronary syndrome (ACS) who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05).

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 and Acute coronary syndrome patients

Estimated number of subjects

3000
Study design details

Main study objective

To describe prescription patterns of antithrombotic drugs in real life among patients with atrial fibrillation and acute coronary syndrome in Sweden, and to study safety and effectiveness endpoints related to the most commonly administered treatment regimens

Outcomes

Composition and frequency of treatment regimens (NOTE: please refer to https://clinicaltrials.gov/ for description of further primary outcomes)

Data analysis plan

The analysis will be of descriptive nature and will be conducted for subgroups of patients: (1) those who did not undergo PCI (“no PCI”), (2) who underwent PCI without stent implant. Frequencies and percentages will be calculated to the variables of interests, continuous and count variables will be described using mean (±SD), proportions, median (quartiles) and minimum and maximum values. 95% confidence intercals will be computed for descriptive varaibles.The main analyses will be made similarly to the intention to treatment principle where patients are grouped according to treatment at baseline not accounting for changes during follow up.Unadjusted event rates according to a regimen and an outcome will be presented in table format as well as displayed as Kaplan Meier graphs. Multivariable Cox regression with adjustments for cofactors will be made pairwise for the major treatment pathways