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Clinical Trials/NCT03058601
NCT03058601
Completed
Not Applicable

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

AstraZeneca0 sites1,650 target enrollmentJanuary 4, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
AstraZeneca
Enrollment
1650
Primary Endpoint
Incidence of all cause death in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 4, 2016
End Date
March 31, 2016
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidence of all cause death in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)

Time Frame: From index date up to 12 months

Incidence of vascular death in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: From index date up to 12 months

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)

Time Frame: From index date up to 12 months

Incidence of stroke in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: From index date up to 12 months

Secondary Outcomes

  • 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)
  • Incidence of 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)
  • Incidence of dyspnoea in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)(From index date up to 12 months)

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