Acute Coronary SyndromeNCT03058601
Outcomes in UK ACS Patients Prescribed Ticagrelor
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 1,650 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jan 2016to 31 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Primary care prescription for clopidogrel or prasugrel between the ACS date and the index date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Outcomes of Patients With Acute Coronary Syndromes Prescribed Ticagrelor in UK Primary Care: a Retrospective Cohort Study
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.
- Conditions
- Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: From index date up to 12 months
Incidence of stroke in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
Measured: From index date up to 12 months
Incidence of vascular death in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From index date up to 12 months
Incidence of dyspnoea in patients treated with ticagrelor in primary care following Acute Coronary Syndrome (ACS)
Measured: 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)
Measured: 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)
Measured: From index date up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start4 Jan 2016
- Primary completion31 Mar 2016
- Study completion31 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058601
- Sponsor's protocol ID
- D5130R00027
- Other IDs
- EUPAS17107
- Status last verified
- May 2019
- First submitted
- 9 Feb 2017
- Last updated
- 21 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Outcomes of Patients With Acute Coronary Syndromes Prescribed Ticagrelor in UK Primary Care: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03058601
- Acronym / sponsor ID
- D5130R00027
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,650 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Primary care prescription for clopidogrel or prasugrel between the ACS date and the index date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
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
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
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
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: From index date up to 12 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.