NCT03058601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

February 9, 2017

Last Update Submit

May 20, 2019

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

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

    From index date up to 12 months

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

    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)

    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)

    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)

    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)

    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)

    From index date up to 12 months

Secondary Outcomes (4)

  • Incidence of bleeding 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

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Primary care prescription for clopidogrel or prasugrel between the ACS date and the index date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Luton, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 23, 2017

Study Start

January 4, 2016

Primary Completion

March 31, 2016

Study Completion

March 31, 2016

Last Updated

May 21, 2019

Record last verified: 2019-05

Locations

GB(1)