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Completed

NCT Number: NCT03058601

Outcomes in UK ACS Patients Prescribed Ticagrelor

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Luton, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

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

    Time frame: From index date up to 12 months

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

    Time frame: From index date up to 12 months

  3. Time to event for bleeding in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)

    Time frame: From index date up to 12 months

  4. Time to event for dyspnoea in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)

    Time frame: From index date up to 12 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 23, 2017
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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