Patient Characteristics, Persistence to Treatment and Outcome Events in Patients Treated With Ticagrelor 60 mg After Myocardial Infarction in Real-world Clinical Practice

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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An Observational, Register-based Study on Ticagrelor 60 mg Persistence and Event Rates in Clinical Practice in the US and Europe.

Conditions
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Myocardial Infarction (MI)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary Analysis Population: Hospitalisation with a primary diagnosis of MI during the eligibility period Ticagrelor cohort: A first prescription of ticagrelor 60 mg after the most recent hospitalisation with a primary diagnosis of MI. Non-ticagrelor cohort: A prescription of clopidogrel, prasugrel or ticlopidine, or no prescription for any of these medications, at a comparable timepoint relative to their MI as for the ticagrelor cohort Secondary Analysis Population: The qualifying prescription 12-36 months after a hospitalisation with a primary diagnosis of MI and treatment with an ADP receptor antagonist (clopidogrel, prasugrel, ticagrelor 90 mg, ticlopidine) ≤12 months prior to the qualifying prescription, or the qualifying prescription 12-24 months after a hospitalisation with a primary diagnosis of MI AND Age ≥50 years At least one of the following risk factors: Age ≥ 65 years Diabetes mellitus requiring medication A second prior MI Evidence of multivessel coronary artery disease Chronic non-end-stage renal dysfunction Exclusion Criteria: Applicable to the Primary and Seconday Analysis Populations: Dies, emigrates, or disenrolls from the database (where applicable) prior to the ticagrelor approval date. Ineligibility for ticagrelor use (restricted to the conditions possible to capture within the data sources)-one or more of the following: Concomitant use of an anticoagulant Prior ischaemic stroke Prior history of intracranial bleeding Severe hepatic impairment Gastrointestinal bleeding Renal failure requiring dialysis Concomitant use of a strong CYP3A4 inhibitor or inducer <1 year of data available prior to the qualifying MI (for assessment of patient characteristics at qualifying MI)

Ages Eligible for Study
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Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ticagrelor cohort<br>Patients initiating ticagrelor 60 mg after an MI, with no prescription of ticagrelor 60 mg prior to their qualifying MI. The qualifying MI is defined as the most recent MI occurring before the first ticagrelor 60 mg prescription. | |
| Non-ticagrelor cohort<br>Patients not prescribed ticagrelor 60 mg at a comparable time point after an MI as matched patients in the ticagrelor cohort. Patients may be prescribed another P2Y12 inhibitor or aspirin alone. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment persistence | Treatment discontinuation is defined on the basis of calculated days of supply from prescription data. | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Infarction, Ticagrelor 60 mg, Antiplatelet agents, Medication persistence, Drug utilization, Bleeding, MACE, Cardiovascular, Cohort study, Observational study, Real-world evidence