Outcomes in UK ACS Patients Prescribed Ticagrelor

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058601
• Other study ID #: D5130R00027
• Secondary ID: EUPAS17107
• Status: Completed
• Start date: January 4, 2016
• Est. completion date: March 31, 2016

Study information

• Verified date: May 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1650
• Est. completion date: March 31, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Incidence of stroke in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)		From index date up to 12 months
Primary	Incidence of vascular death in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)		From index date up to 12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Incidence of bleeding in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)		From index date up to 12 months
Secondary	Incidence of dyspnoea in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)		From index date up to 12 months
Secondary	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
Secondary	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

External Links

•   CSR Synopsis