Acute Coronary SyndromeEPICOR ASIANCT01361386
Long-tErm Follow-uP of antithrombotIc Management Patterns In Acute CORonary Syndrome Patients in Asia
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 108 sites in 7 countries.
Trial summary
The purpose of this study is to describe the short-and long-tern (i.e. up to 2 years following the index event) AMPs in patients hospitalized for an acute coronary syndrome (i.e. STEMI or NSTE-ACS), and to document clinical outcomes, economic aspects and impact on quality of life of these AMPs in a 'real-life' setting. 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
- 13,011 participants
- Where
- 108 sitesin 7 countries
- Study dates
- Jun 2011to May 2014
- 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: Asian patients hospitalized for ACS within 48 hours of symptom onset and who have a final diagnosis of unstable angina (UA), STEMI or non-ST-segment elevation myocardial infarction (NSTEMI).
Who may be able to join
- Written informed consent has been provided.
- Diagnosis of STEMI, NSTEMI or UA
- Hospitalization for the first time within 48 hours of onset of symptoms.
Who cannot join
- UA, STEMI, NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
- Current participation in a randomised interventional clinical trial.
Trial locations and contacts
108 sites in 7 countries.
108 sites in 7 countries
China45 sites
Research Site
Baoding, Hebei
Research Site
Beijing, Beijing Municipality
Research Site
Changchun, Jilin
Research Site
Changsha, Hunan
Research Site
Changzhi, Shanxi
Research Site
Chengdu, Sichuan
Research Site
Chongqing, Chongqing Municipality
Research Site
Daqing, Heilongjiang
Research Site
Foshan, Guangdong
Research Site
Fuzhou, Fujian
Research Site
Guangzhou, Guangdong
Research Site
Guiyang, Guizhou
Research Site
Hangzhou, Zhejiang
Research Site
Harbin, Heilongjiang
Research Site
Hefei, Anhui
Research Site
Hong Kong
Research Site
Jinan, Shandong
Research Site
Jinzhong, Shanxi
Research Site
Jinzhou, Liaoning
Research Site
Kunming, Yunnan
Research Site
Lanzhou, Gansu
Research Site
Nanjing, Jiangsu
Research Site
Nanning, Guangxi
Research Site
Ningxia
Research Site
Qingdao
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenyang, Liaoning
Research Site
Shenzhen, Guangdong
Research Site
Shihezi, Xinjiang
Research Site
Shijiazhuang, Hebei
Research Site
Shiyan, Hubei
Research Site
Taiyuan, Shanxi
Research Site
Tangshan, Hebei
Research Site
Tianjin, Tianjin Municipality
Research Site
Urumuqi, Xinjiang
Research Site
Wuhan, Hubei
Research Site
Wuhu, Anhui
Research Site
Wuxi, Jiangsu
Research Site
Xi'an, Shaanxi
Research Site
Xining, Qinghai
Research Site
Xuzhou, Jiangsu
Research Site
Yingkou, Liaoning
Research Site
Yulin, Guangxi
Research Site
Zhengzhou, Henan
Research Site
Zhenjiang, Jiangsu
India26 sites
Research Site
Ahmedabad, Gujarat
Research Site
Ajmer, Rajasthan
Research Site
Bangalore, Karnataka
Research Site
Bhopal, Madhya Pradesh
Research Site
Bilāspur, Madhya Pradesh
Research Site
Chennai, Tamil Nadu
Research Site
Chhatrapati Sambhajinagar, Maharashtra
Research Site
Coimbatore, Tamil Nadu
Research Site
Delhi, National Capital Territory of Delhi
Research Site
Gurgaon, Haryana
Research Site
Guwahati, Assam
Research Site
Hyderabad, Andhra Pradesh
Research Site
Jaipur, Rajasthan
Research Site
Kochi, Kerala
Research Site
Kolkata, West Bengal
Research Site
Lucknow, Uttar Pradesh
Research Site
Ludhiana, Punjab
Research Site
Madurai, Tamil Nadu
Research Site
Manipal, Karnataka
Research Site
Mohali, Punjab
Research Site
Mumbai, Maharashtra
Research Site
Nagpur, Maharashtra
Research Site
Pune, Maharashtra
Research Site
Surat, Gujarat
Research Site
Trivandrum, Kerala
Research Site
Vadodara, Gujarat
Thailand20 sites
Research Site
Bangkoknoi, Bangkok
Research Site
Huaykwang, Bangkok
Research Site
Klongluang, Changwat Pathum Thani
Research Site
Muang, Changwat Chanthaburi
Research Site
Muang, Changwat Chon Buri
Research Site
Muang, Changwat Lampang
Research Site
Muang, Changwat Nan
Research Site
Muang, Changwat Phitsanulok
Research Site
Muang, Changwat Songkhla
Research Site
Muang, Changwat Suphan Buri
Research Site
Muang, Changwat Surat Thani
Research Site
Muang, Chiangmai
Research Site
Muang, Chiangrai
Research Site
Muang, Khonkaen
Research Site
Muang, Nakornratchaseema
Research Site
Muang, Udonthani
Research Site
PathumWan, Bangkok
Research Site
Payathai, Bangkok
Research Site
Rachathevi, Bangkok
Research Site
Saimai, Bangkok
South Korea12 sites
Research Site
Bucheon-si, Gyeonggi-do
Research Site
Busan, Busan
Research Site
Cheonan, Chungcheongnam-do
Research Site
Chuncheon, Chuncheon
Research Site
Deagu, Deagu
Research Site
Goyang-si, Gyeonggi-do
Research Site
Gwangju, Gwangju
Research Site
Iksan, Jeollabuk-do
Research Site
Jeju City, Jeju-do
Research Site
Seoul, Seoul
Research Site
Suwon, Gyeonggi-do
Research Site
Yangsan, Gyeongsangnam-do
Vietnam2 sites
Research Site
Ho Chi Minh City, Ho Chi Minh City
Research Site
Huế, Hue
About this study
Official title: Long-Term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Asia
The purpose of this study is to describe the short-and long-tern (i.e. up to 2 years following the index event) AMPs in patients hospitalized for an acute coronary syndrome (i.e. STEMI or NSTE-ACS), and to document clinical outcomes, economic aspects and impact on quality of life of these AMPs in a 'real-life' setting.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Long-term follow up, Antithrombotic management patterns, Acute Coronary Syndrome, Asia, quality of life
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
short- and long-term medication and treatment prescribed by physicians in real-life setting
Measured: up to 3 years
Secondary outcomes (3)
clinical outcome (Cardiovascular events)
Measured: up to 3 years
cost of hospitalization
Measured: up to 3 years
quality of life (EQ-5D questionnaire)
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 13,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy Yeoman, Study director, AstraZenecaProf. Huo Yong, Study chair, Peking University 1st HospitalJayanti Visvanathan, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361386
- Sponsor's protocol ID
- NIS-CAP-XXX-2011/1
- Acronym
- EPICOR ASIA
- Status last verified
- Jun 2014
- First submitted
- 23 May 2011
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Huo Y, Van de Werf F, Han Y, Rossello X, Pocock SJ, Chin CT, Lee SW, Li Y, Jiang J, Vega AM, Medina J, Bueno H. Long-Term Antithrombotic Therapy and Clinical Outcomes in Patients with Acute Coronary Syndrome and Renal Impairment: Insights from EPICOR and EPICOR Asia. Am J Cardiovasc Drugs. 2021 Jul;21(4):471-482. doi: 10.1007/s40256-020-00447-5. Epub 2021 Feb 4.
PubMed 33537947Guan S, Xu X, Li Y, Li J, Guan M, Wang X, Jing Q, Huo Y, Han Y. Impact of Diabetes Mellitus on Antithrombotic Management Patterns and Long-Term Clinical Outcomes in Patients With Acute Coronary Syndrome: Insights From the EPICOR Asia Study. J Am Heart Assoc. 2020 Nov 17;9(22):e013476. doi: 10.1161/JAHA.119.013476. Epub 2020 Nov 7.
PubMed 33164633Zhang S, Wang W, Sawhney JPS, Krittayaphong R, Kim HS, Nhan VT, Lee SW, Ong TK, Chin CT, Pocock SJ, Huo Y, Qian J, Ge J. Antithrombotic management and long-term outcomes following percutaneous coronary intervention for acute coronary syndrome in Asia. Int J Cardiol. 2020 Jul 1;310:16-22. doi: 10.1016/j.ijcard.2020.01.008. Epub 2020 Mar 17.
PubMed 32192746Jan S, Lee SW, Sawhney JPS, Ong TK, Chin CT, Kim HS, Krittayaphong R, Nhan VT, Pocock SJ, Vega AM, Hayashi N, Huo Y. Predictors of high-cost hospitalization in the treatment of acute coronary syndrome in Asia: findings from EPICOR Asia. BMC Cardiovasc Disord. 2018 Jul 4;18(1):139. doi: 10.1186/s12872-018-0859-4.
PubMed 29973147
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Asia
- ClinicalTrials.gov ID
- NCT01361386
- Acronym / sponsor ID
- EPICOR ASIA / NIS-CAP-XXX-2011/1
- Conditions
- Acute Coronary Syndrome
- Keywords
- Long-term follow up, Antithrombotic management patterns, Acute Coronary Syndrome, Asia, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,011 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 May 2011 (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.
The purpose of this study is to describe the short-and long-tern (i.e. up to 2 years following the index event) AMPs in patients hospitalized for an acute coronary syndrome (i.e. STEMI or NSTE-ACS), and to document clinical outcomes, economic aspects and impact on quality of life of these AMPs in a 'real-life' setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asian patients hospitalized for ACS within 48 hours of symptom onset and who have a final diagnosis of unstable angina (UA), STEMI or non-ST-segment elevation myocardial infarction (NSTEMI).
Key inclusion criteria (3 listed)
- Written informed consent has been provided.
- Diagnosis of STEMI, NSTEMI or UA
- Hospitalization for the first time within 48 hours of onset of symptoms.
Key exclusion criteria (2 listed)
- UA, STEMI, NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
- Current participation in a randomised interventional clinical trial.
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
short- and long-term medication and treatment prescribed by physicians in real-life setting
Time frame: up to 3 years
3 secondary outcomes
clinical outcome (Cardiovascular events)
Time frame: up to 3 years
cost of hospitalization
Time frame: up to 3 years
quality of life (EQ-5D questionnaire)
Time frame: up to 3 years
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 16 Jun 2014.
- Derived from this study: PubMed 33537947Huo Y, Van de Werf F, Han Y, Rossello X, Pocock SJ, Chin CT, Lee SW, Li Y, Jiang J, Vega AM, Medina J, Bueno H. Long-Term Antithrombotic Therapy and Clinical Outcomes in Patients with Acute Coronary Syndrome and Renal Impairment: Insights from EPICOR and EPICOR Asia. Am J Cardiovasc Drugs. 2021 Jul;21(4):471-482. doi: 10.1007/s40256-020-00447-5. Epub 2021 Feb 4.
- Derived from this study: PubMed 33164633Guan S, Xu X, Li Y, Li J, Guan M, Wang X, Jing Q, Huo Y, Han Y. Impact of Diabetes Mellitus on Antithrombotic Management Patterns and Long-Term Clinical Outcomes in Patients With Acute Coronary Syndrome: Insights From the EPICOR Asia Study. J Am Heart Assoc. 2020 Nov 17;9(22):e013476. doi: 10.1161/JAHA.119.013476. Epub 2020 Nov 7.
- Derived from this study: PubMed 32192746Zhang S, Wang W, Sawhney JPS, Krittayaphong R, Kim HS, Nhan VT, Lee SW, Ong TK, Chin CT, Pocock SJ, Huo Y, Qian J, Ge J. Antithrombotic management and long-term outcomes following percutaneous coronary intervention for acute coronary syndrome in Asia. Int J Cardiol. 2020 Jul 1;310:16-22. doi: 10.1016/j.ijcard.2020.01.008. Epub 2020 Mar 17.
- Derived from this study: PubMed 29973147Jan S, Lee SW, Sawhney JPS, Ong TK, Chin CT, Kim HS, Krittayaphong R, Nhan VT, Pocock SJ, Vega AM, Hayashi N, Huo Y. Predictors of high-cost hospitalization in the treatment of acute coronary syndrome in Asia: findings from EPICOR Asia. BMC Cardiovasc Disord. 2018 Jul 4;18(1):139. doi: 10.1186/s12872-018-0859-4.
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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.
Guy Yeoman study director
AstraZeneca
Prof. Huo Yong study chair
Peking University 1st Hospital
Jayanti Visvanathan study chair
AstraZeneca
108 sites in 7 countries: 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 108 sites in 7 countries.
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 3 inclusion and 2 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 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 108 sites in China, India, Thailand, South Korea, Malaysia and 2 more countries. 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?
short- and long-term medication and treatment prescribed by physicians in real-life setting (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01361386, which also lists 4 linked publications.
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 16 Jun 2014.