A pharmacoepidemiological study to examine patient characteristics, drug utilization pattern and crude incidence rates of selected outcomes in new users of ticagrelor,clopidogrel and prasugrel in national Swedish registries.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/22401
• EU PAS number:
  EUPAS5238
• Study ID:
  22401
• Official title and acronym:
  A pharmacoepidemiological study to examine patient characteristics, drug utilization pattern and crude incidence rates of selected outcomes in new users of ticagrelor,clopidogrel and prasugrel in national Swedish registries.
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  This is a retrospective cohort study using the Swedish national health registers. Individual data will be linked between registers by the unique personal identification number. All patients aged 20 to 84 years before their first study drug dispensing will be included in the study. In order to capture usual clinical practice no exclusion criteria will be applied. The study period starts the first of June 2011 and continues for one year. Accumulated information on number of ticagrelor exposed subjects will be evaluated after one year and projected information from the observed numbers and crude incidence rates of the selected outcomes will mandate the need to extend the study.Three cohorts will be ascertained, all first time users of ticagrelor and all first time users of clopidogrel and prasugrel, respectively. These three cohorts of first time users will include both patients who have switched from another thienopyridine antiplatelet as well as patients who are thienopyridine antiplatelet naïve at the time of the first study drug dispensing. Individuals with more than one of these three antiplatelet drugs dispensed on the same day will be excluded. The study objectives are to provide a detailed description of patients who are prescribed ticagrelor for the first time and to compare them with patients who are prescribed clopidogrel and prasugrel for the first time, and to estimate potential off-label usage of ticagrelor. The safety objectives of the study are to ascertain incident cases of selected adverse outcomes among new users in the three cohorts of ticagrelor, clopidogrel and prasugrel and to estimate the crude incidence rate of selected adverse outcomes among new users in the three cohorts of ticagrelor, clopidogrel and prasugrel.
• Study status:
  Finalised

Research institution and networks

Institutions

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Study timelines

Date when funding contract was signed

Planned: 30/04/2013

Actual: 25/04/2013

Study start date

Planned: 02/12/2013

Actual: 16/12/2013

Data analysis start date

Planned: 01/04/2015

Actual: 01/06/2015

Date of final study report

Planned: 15/09/2015

Actual: 15/11/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)