Health outcomes of patients with acute coronary syndromes prescribed ticagrelor in UK primary care: a retrospective cohort study (Outcomes in UK ACS patients prescribed ticagrelor)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  BRILIQUE
• Medical condition to be studied:
  Acute coronary syndrome

  Myocardial infarction

  Dyspnoea

  Cerebrovascular accident

  Death

  Extravasation blood

Population studied

• Short description of the study population:
  Patients with a first prescription of ticagrelor, between Dec 2010 and July 2014, with a recorded ACS event within the three months prior to and including the index date and no prescription of clopidogrel or prasugrel between the ACS event and first ticagrelor prescription.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1650

Study design details

• Main study objective:
  To assess the incidence and time to event for the following in patients treated with ticagrelor in primary care following ACS events:• composite outcome of MI, Stroke or death from vascular causes• individual vascular events (MI, Stroke, and death from vascular causes)• all cause death
• Outcomes:
  To assess the incidence and time to event for the following in patients treated with ticagrelor in primary care following ACS events:• composite outcome of MI, Stroke or death from vascular causes• individual vascular events (MI, Stroke, and death from vascular causes)• all cause death, Rates of vascular events stratified by the following factors• Aged <75 and 75 or older• MI vs UA (Index ACS)• Medically managed vs interventionally managed• Diabetic vs non-diabeticIncidence and time to event for the following:• Bleeding events and stratified by presence/absence of bleeding risk factors • Dyspnoea and stratified by presence/absence of dyspnoea risk factors
• Data analysis plan:
  Baseline characteristics will be presented for demographics, CV history, ACS type, interventions associated with ACS, prior oral antiplatelet treatment, comorbidities, and secondary prevention treatment. Incidence rates (95% CI) will be presented per 100 patient years for the composite outcome and individual cardiovascular events, bleeding and dyspnoea. Patients will be followed from index date (first prescription for ticagrelor in primary care) for maximum of 12 months. Rates of vascular events will be stratified by the following risk factors: aged <75 years/ ≥75 years, MI vs UA, medically vs interventionally managed, and diabetic vs non-diabetic. Bleeding events will be stratified by presence/absence of bleeding risk factors. Dyspnoea will be stratified by presence or absence of dyspnoea risk factors. Time to first composite event, CV event, time to death, time to first bleeding event and time to first dyspnoea event on therapy will be described in Kaplan-Meier plots.