Clinical trial NCT03058601: Outcomes in UK ACS Patients Prescribed Ticagrelor
Official title: Health Outcomes of Patients With Acute Coronary Syndromes Prescribed Ticagrelor in UK Primary Care: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 1650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients prescribed ticagrelor in primary care, following Acute Cornoary Syndrome (ACS), for the first time (Dec 2010 - Mar 2015) in Cliniical Practice Research Datalink primary care data and followed for up to 12 months.

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.


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

Primary outcomes:
measure: 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)
timeFrame: From index date up to 12 months
measure: Incidence of myocardial infarction (MI) in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
timeFrame: From index date up to 12 months
measure: Incidence of all cause death in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
timeFrame: From index date up to 12 months
measure: Incidence of stroke in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
timeFrame: From index date up to 12 months
measure: Incidence of vascular death in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
timeFrame: From index date up to 12 months
measure: 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)
timeFrame: From index date up to 12 months
measure: Time to event for myocardial infarction (MI) in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
timeFrame: From index date up to 12 months
measure: Time to event for all cause death in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
timeFrame: From index date up to 12 months
measure: Time to event for stroke in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
timeFrame: From index date up to 12 months
measure: Time to event for vascular death in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
timeFrame: From index date up to 12 months
Secondary outcomes:
measure: Incidence of bleeding in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
timeFrame: From index date up to 12 months
measure: Incidence of dyspnoea in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
timeFrame: From index date up to 12 months
measure: Time to event for bleeding in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
timeFrame: From index date up to 12 months
measure: Time to event for dyspnoea in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
timeFrame: From index date up to 12 months
Other outcomes:
Locations:
city: Luton
country: United Kingdom
Study officials:
References: