Status: Finalised First registered on: 21/11/2013
Last updated on: 24/01/2018
1. Study identification
EU PAS Register NumberEUPAS5238
Official titleA pharmacoepidemiological study to examine patient characteristics, drug utilizationpattern and crude incidence rates of selected outcomes in new users of ticagrelor,clopidogrel and prasugrel in national Swedish registries.
Study title acronym
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCentre for Pharmacoepidemiology (CPE)
Department/Research groupDepartment of medicine/Clinical epidemiology unit
Organisation/affiliationKarolinska Institutet
Website/Homepagehttp://ki.se/ki/jsp/polopoly.jsp?l=en&d=18761
Details of (Primary) lead investigator
Title Dr
Last name Kieler
First name Helle
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/04/201325/04/2013
Start date of data collection02/12/201316/12/2013
Start date of data analysis01/04/201501/06/2015
Date of interim report, if expected
Date of final study report15/09/201515/11/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Andersen
First name Morten
Address line 1Department of medicine
Address line 2Clinical epidemiology unit, T2 
Address line 3Karolinska University Hospital 
CityStockholm 
Postcode171 76 
CountrySweden
Phone number (incl. country code)46-8-51776178 
Alternative phone number 
Fax number (incl. country code) 
Email address morten.andersen@ki.se
Public Enquiries
Title Dr 
Last name Kieler 
First name Helle 
Address line 1Department of medicine 
Address line 2Clinical epidemiology unit, T2 
Address line 3Karolinska University Hospital Solna 
CityStockholm 
Postcode171 76 
CountrySweden 
Phone number (incl. country code)46851770629 
Alternative phone number46736334492 
Fax number (incl. country code)46851779304 
Email address helle.kieler@ki.se 
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