Acute Coronary SyndromesEPICORNCT02305680
Long-term Follow-up of antithrombotIc Management Patterns in Acute Coronary Syndrome Patients in Asia-China Extension
An observational study of Acute Coronary Syndromes, run by AstraZeneca at 33 sites in China.
Trial summary
This study is to describe the long-term antithrombotic management patterns in a real-life setting for patients hospitalized with an acute coronary syndrome in China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndromes
- How many people
- 2,334 participants
- Where
- 33 sitesChina
- Study dates
- 17 Dec 2014to 5 Apr 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a history of acute coronary syndromes in China
Who may be able to join
- Written informed consent has been provided.
- Contact Order Form has been provided
- Aged 18 years or older.
- Enrolled in EPICOR Asia study and completed the 2 year follow-up.
Who cannot join
- Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances, alcohol or drug abuse).
- Already included in the EPICOR Asia-China Extension observational study.
- Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy.
- Current participation in an interventional clinical trial.
- Patients receiving ticagrelor beyond 12 months and other off label use.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
China33 sites
Research Site
Baoding
Research Site
Beijing
Research Site
Changzhi
Research Site
Chongqing
Research Site
Guangzhou
Research Site
Guiyang
Research Site
Haerbin
Research Site
Hangzhou
Research Site
Hebei
Research Site
Jilin City
Research Site
Jinan
Research Site
Jinzhong
Research Site
Kunming
Research Site
Lanzhou
Research Site
Nanjing
Research Site
Nanning
Research Site
Shanghai
Research Site
Shenyang
Research Site
Shenzhen
Research Site
Shihezi
Research Site
Taiyuan
Research Site
Tangshan
Research Site
Tianjin
Research Site
Ürümqi
Research Site
Wuhan
Research Site
Wuxi
Research Site
Xi'an
Research Site
Xining
Research Site
Xuzhou
Research Site
Yinchuan
Research Site
Yulin
Research Site
Zhengzhou
Research Site
Zhenjiang
About this study
Official title: EPICOR Asia-China Extension. Long-term Follow-up of antithrombotIc Management Patterns in Acute Coronary Syndrome Patients in Asia-China Extension
This study is to describe the long-term antithrombotic management patterns in a real-life setting for patients hospitalized with an acute coronary syndrome in China.
Read the detailed description
This study is to describe the long-term (3 to 5 years after the acute coronary syndrome index event) antithrombotic management patterns in a real-life setting for patients hospitalized with an acute coronary syndrome (i.e. ST-segment Elevation Myocardial Infarction, Non-ST-segment Elevation Myocardial Infarction, Unstable Angina) in China.
- Conditions
- Acute Coronary Syndromes
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term antithrombotic management patterns in a real-life setting by assessing the medication and treatment prescribed by physicians
Measured: From 2 years after the acute coronary syndrome index event, assessed up to 5 years
Secondary outcomes (3)
Clinical outcomes by record the number and type of cardiovascular and non-cardiovascular events
Measured: From 2 years after the acute coronary syndrome index event, assessed up to 5 years
Health care resource consumption and related costs by assessing the detail hospitalization and outpatient cost.
Measured: From 2 years after the acute coronary syndrome index event, assessed up to 5 years
Quality of life by assessing EQ-5D questionnaire.
Measured: 2 years,2.5years,3years,3.5years,4years,4.5years,5years after the acute coronary syndrome index event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study start17 Dec 2014
- Primary completion5 Apr 2017
- Study completion5 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies 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
- Prospective
- Enrolment
- 2,334 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong Huo, Doctor, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305680
- Sponsor's protocol ID
- D1843R00049
- Other IDs
- NIS-CCN-XXX-2014/1
- Acronym
- EPICOR
- Status last verified
- Sep 2018
- First submitted
- 18 Nov 2014
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPICOR Asia-China Extension. Long-term Follow-up of antithrombotIc Management Patterns in Acute Coronary Syndrome Patients in Asia-China Extension
- ClinicalTrials.gov ID
- NCT02305680
- Acronym / sponsor ID
- EPICOR / D1843R00049
- Conditions
- Acute Coronary Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,334 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2014 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 3 Dec 2014 (estimated)
- 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.
This study is to describe the long-term antithrombotic management patterns in a real-life setting for patients hospitalized with an acute coronary syndrome in China.
Detailed description
This study is to describe the long-term (3 to 5 years after the acute coronary syndrome index event) antithrombotic management patterns in a real-life setting for patients hospitalized with an acute coronary syndrome (i.e. ST-segment Elevation Myocardial Infarction, Non-ST-segment Elevation Myocardial Infarction, Unstable Angina) in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a history of acute coronary syndromes in China
Key inclusion criteria (4 listed)
- Written informed consent has been provided.
- Contact Order Form has been provided
- Aged 18 years or older.
- Enrolled in EPICOR Asia study and completed the 2 year follow-up.
Key exclusion criteria (5 listed)
- Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances, alcohol or drug abuse).
- Already included in the EPICOR Asia-China Extension observational study.
- Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy.
- Current participation in an interventional clinical trial.
- Patients receiving ticagrelor beyond 12 months and other off label use.
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
Long-term antithrombotic management patterns in a real-life setting by assessing the medication and treatment prescribed by physicians
Time frame: From 2 years after the acute coronary syndrome index event, assessed up to 5 years
3 secondary outcomes
Clinical outcomes by record the number and type of cardiovascular and non-cardiovascular events
Time frame: From 2 years after the acute coronary syndrome index event, assessed up to 5 years
Health care resource consumption and related costs by assessing the detail hospitalization and outpatient cost.
Time frame: From 2 years after the acute coronary syndrome index event, assessed up to 5 years
Quality of life by assessing EQ-5D questionnaire.
Time frame: 2 years,2.5years,3years,3.5years,4years,4.5years,5years after the acute coronary syndrome index event
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 17 Sep 2018.
- D1843R00049 EPICOR 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.
Yong Huo, Doctor principal investigator
Peking University First Hospital
33 sites 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 Syndromes, run by AstraZeneca at 33 sites in China.
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 5 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 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in China. 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?
Long-term antithrombotic management patterns in a real-life setting by assessing the medication and treatment prescribed by physicians (time frame: From 2 years after the acute coronary syndrome index event, assessed up to 5 years). 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 17 Sep 2018.