Outcomes in UK ACS Patients Prescribed Ticagrelor

Study Overview
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Brief Summary
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Cohort study using data from Clinical Practice Research Datalink (CPRD). The study cohort includes all patients who received at least one prescription for ticagrelor for the first time between December 2010 and March 2015, following ACS. Patient baseline characteristics will be described: (Age, Gender, Body Mass Index, Smoking status, Sociodemographic status), type of ACS and interventions, CV history and comorbidities, bleeding and respiratory history. The following outcomes will be examined: Incidence of vascular events (composite MI, Stroke, vascular death, specific vascular event and all cause death), incidence of bleeding and incidence of dysponea. Time to event for vascular events, bleeding and dyspnoea.

Official Title
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Health Outcomes of Patients With Acute Coronary Syndromes Prescribed Ticagrelor in UK Primary Care: a Retrospective Cohort Study

Conditions
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Acute Coronary Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First prescription (index date) for ticagrelor between Dec 2010 and Mar 2015 At least 12 months history in database prior to first ticagrelor prescription Linkage to Hospital Episode Statistics (HES) Acute Coronary Syndrome (ACS) event in the three months prior to and including the index date Exclusion Criteria: Primary care prescription for clopidogrel or prasugrel between the ACS date and the index date

Ages Eligible for Study
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Minimum Age: 18 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of composite outcome of myocardial infarction (MI), Stroke or death from vascular causes in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS) |  | From index date up to 12 months | 
| Incidence of myocardial infarction (MI) in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS) |  | From index date up to 12 months | 
| Incidence of all cause death in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS) |  | From index date up to 12 months | 
| Incidence of stroke in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS) |  | From index date up to 12 months | 
| Incidence of vascular death in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS) |  | From index date up to 12 months | 
| Time to event for composite outcome of myocardial infarction (MI), Stroke or death from vascular causes in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS) |  | From index date up to 12 months | 
| Time to event for myocardial infarction (MI) in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS) |  | From index date up to 12 months | 
| Time to event for all cause death in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS) |  | From index date up to 12 months | 
| Time to event for stroke in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS) |  | From index date up to 12 months | 
| Time to event for vascular death in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS) |  | From index date up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bleeding in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS) |  | From index date up to 12 months | 
| Incidence of dyspnoea in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS) |  | From index date up to 12 months | 
| Time to event for bleeding in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS) |  | From index date up to 12 months | 
| Time to event for dyspnoea in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS) |  | From index date up to 12 months |