This is an observational study based on secondary data extracted from multiple register-based data sources in the US and Europe (Sweden, United Kingdom, Italy, Germany). The study will include patients initiating treatment with ticagrelor 60 mg after a myocardial infarction in real-world clinical practice, and describe their patient characteristics and duration of treatment. If the a priori threshold of 5,000 person-years on treatment with ticagrelor 60 mg is met, outcome events (bleeding and cardiovascular events) will also be analysed and described.
This observational cohort study will include patients initiating treatment with ticagrelor 60 mg after a myocardial infarction (MI), and describe their patient characteristics and persistence to treatment. To contextualise the characteristics of the ticagrelor patients, two reference cohorts will be created, including patients treated with another P2Y12 inhibitor than ticagrelor (clopidogrel, prasugrel, or ticlopidine), and patients not treated with any P2Y12 inhibitor, within a comparable timepoint from an MI as for the ticagrelor 60 mg patients. If the a priori threshold of 5,000 person-years on treatment with ticagrelor 60 mg is met, to ensure sufficient precision, outcome events (bleeding and cardiovascular events) will also be analysed and described. Outcome events will only be described in the ticagrelor cohorts; no comparison of outcomes will be made between the ticagrelor and the reference cohorts. The primary outcome is bleeding requiring hospitalisation. The secondary outcomes include components of the primary outcome, and cardiovascular outcomes. Persistence to treatment with ticagrelor 60 mg will also be assessed The study will be performed in the US and 4 European countries (Sweden, United Kingdom, Italy, Germany).
Study Type
OBSERVATIONAL
Enrollment
7,035
Research Site
Bethesda, Maryland, United States
Research Site
Waltham, Massachusetts, United States
Research Site
Wismar, Germany
Research Site
Rome, Italy
Research Site
Stockholm, Sweden
Research Site
London, United Kingdom
Treatment persistence
Treatment discontinuation is defined on the basis of calculated days of supply from prescription data.
Time frame: From initiation of ticagrelor 60 mg to discontinuation, switch or death, assessed throughout the study period up to a maximum of 36 months
Incidence of Major bleeding
Major bleeding is defined as bleeding requiring hospitalisation.
Time frame: From initiation of ticagrelor 60 mg until the date of a major bleeding event, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months
Incidence of Bleeding events
* Intracranial haemorrhage * Gastrointestinal bleeding requiring hospitalisation * Bleeding other than intracranial haemorrhage or gastrointestinal bleeding requiring hospitalisation * Fatal bleeding * Bleeding not requiring hospitalisation (managed in outpatient care/emergency care not requiring hospitalisation)
Time frame: From initiation of ticagrelor 60 mg until the date of a bleeding event, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months
Incidence of Cardiovascular (CV) events
* Composite of hospitalisation for MI or stroke, and all-cause mortality * Composite of hospitalisation for MI or stroke, and CV death (three-point MACE) * Hospitalisation for MI, hospitalisation for stroke, hospitalisation for ischaemic stroke, CV death, CHD death, all-cause mortality assessed individually
Time frame: From initiation of ticagrelor 60 mg until the date of a CV event, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months
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