Coronary Artery DiseaseOPT-CADNCT01735305
Optimal Antiplatelet Therapy for Chinese Patients With Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Shenyang Northern Hospital at 107 sites in China.
Trial summary
Antiplatelet therapy is the cornerstone for the prevention of atherothrombosis in patients with coronary artery disease (CAD). However, the efficacy and safety of antiplatelet therapy are varied due to ethnic and/or individual variability. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 14,032 participants
- Where
- 107 sitesChina
- Study dates
- Nov 2012to Mar 2015
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient of coronary heart disease receiving any antiplatelet therapy
Who may be able to join
- Clinical diagnosis of coronary heart disease
- Age >= 18 years old
- receiving any antiplatelet agents
- Informed written consent signed
Who cannot join
- With severe disease and life expectancy for 6 months or less
- Difficult to attain follow-up situations judged by researchers (travel, speech or mental disorder, etc.)
- Taking part in an interventional clinical research
Trial locations and contacts
107 sites in 1 country.
107 sites in 1 country
China107 sites
Anshan central hospital
Anshan, Liaoning
Anshan hospital affiliated of China Medical University
Anshan, Liaoning
The first affiliated hospital of Liaoning Medical University
Anshan, Liaoning
The people's hospital of Xiuyan
Anshan, Liaoning
The third hospital of Anshan
Anshan, Liaoning
Beijing Fuwai Hospital
Beijin, Beijing Municipality
Beijing Anzhen Hospital
Beijing, Beijing Municipality
Navy General Hospital
Beijing, Beijing Municipality
The 304th Hospital of PLA
Beijing, Beijing Municipality
The 306th of PLA
Beijing, Beijing Municipality
The Luhe teaching hospital of the Capital Medical University
Beijing, Beijing Municipality
The People's Hospital of Beijing University
Beijing, Beijing Municipality
Yanshan hospital
Beijing, Beijing Municipality
The first affiliated hospital of Bengbu Medical College
Bengbu, Anhui
Central Hospital of Changchun
Changchun, Jilin
The affiliated hospital to Changchun University of Chinese Medicine
Changchun, Jilin
The China-Japan union hospital of Jilin University
Changchun, Jilin
The First Affiliated Hospital of Jilin University
Changchun, Jilin
The Second Affiliated Hospital of Jilin University
Changchun, Jilin
The first hospital of Changshan
Changshan, Hunan
Sichuan military general hospital
Chengdu, Sichuan
Third Military Medical University Xinqiao Hospital
Chongqing, Chongqing Municipality
Dalian municipal central hospital affiliated of Dalian Medical University
Dalian, Liaoning
The 210th Hospital of PLA
Dalian, Liaoning
Zhongshan Hospital Affiliated to Dalian University
Dalian, Liaoning
The 230th of PLA
Dandong, Liaoning
The people's hospital of Dandong
Dandong, Liaoning
Daqing oil field hospital
Daqing, Heilongjiang
Central Hospital affiliated to Shenyang Medical College
Fengtian, Liaoning
Fushun central hospital
Fushun, Liaoning
The 7th hospital of China Medical University
Fushun, Liaoning
The Second Affiliated and gynecology and obstetirs hospital of Fuxin city
Fuxin, Liaoning
The First Affiliated Hospital of Guangzhou Medical College
Guangdong, Guangdong
General hospital of armed police foreces in Guangzhou
Guangzhou, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong
Guangzhou Baiyun district hospital
Guangzhou, Guangdong
Guangzhou military region general hospital
Guangzhou, Guangdong
Guangzhou Panyu district central hospital
Guangzhou, Guangdong
Liwan District People's Hospital of Guangzhou
Guangzhou, Guangdong
The first hospital of Guangzhou
Guangzhou, Guangdong
Guizhou provincial people's hospital
Guiyang, Guizhou
The people's hospital of Haicheng
Haicheng, Liaoning
Affiliated hospital of Hebei University of Engineering
Handan, Hebei
Hangzhou first people's hospital
Hangzhou, Zhejiang
Heilongjiang provincial hospital
Harbin, Heilongjiang
The 211st of PLA
Harbin, Heilongjiang
The People's Hospital of Hebi
Hebi, Henan
The 11st of PLA
Huiyuan, Xinjiang
The people's hospital of Huzhu
Huzhu, Qinghai
The Affiliated Hospital of Jinggangshan University
Ji’an, Jiangxi
The 222nd of PLA
Jilin City, Jilin
Jinan military general hospital
Jinan, Shandong
The 205th of PLA
Jinzhou, Liaoning
The third affiliated hospital of Liaoning medical College
Jinzhou, Liaoning
Lanzhou military region general hospital
Lanzhou, Gansu
Xizang military general hospital
Lhasa, Tibet
Central hospital of Liaoyang
Liaoyang, Liaoning
Liaoyang Chemical General Hospital
Liaoyang, Liaoning
The 201th Hospital of PLA
Liaoyang, Liaoning
The 2nd people's hospital of Liaoyang
Liaoyang, Liaoning
Meihekou central hospital
Meihekou, Jilin
The general hospital of Xilingol League
Mositai, Inner Mongolia
The first hospital of Nanjing
Nanjing, Jiangsu
The 3rd people's hospital of Nanning
Nanning, Guangxi
The central hospital of Nantong
Nantong, Jiangsu
The 152nd Hospital of PLA
Pingdingshan, Henan
Jiaozhou central hospital
Qingdao, Shandong
The third affiliated hospital of Qiqihar Medical University
Qiqihar, Heilongjiang
The People's Hospital of Tangxian
Renhou, Hebei
The people's hospital of Rongcheng
Rongcheng, Hebei
The 425th of PLA
Sanya, Hainan
Eastern hospital in Shanghai
Shanghai, Shanghai Municipality
Jinqiu Hospital
Shenyang, Liaoning
Liaoning northern hospital
Shenyang, Liaoning
Shenyang the forth hospital of people
Shenyang, Liaoning
The 202nd Hospital of PLA
Shenyang, Liaoning
The 242nd of PLA
Shenyang, Liaoning
The 245th of PLA
Shenyang, Liaoning
The 463rd Hospital of PLA
Shenyang, Liaoning
The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning
The first people's hospital of Shenyang
Shenyang, Liaoning
The Forth affiliated hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning
The Second Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning
The Third Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning
Traditional Chinese Medicine hospital of Shenyang
Shenyang, Liaoning
Shenzhen Longgang center hospital
Shenzhen, Guangdong
Bethune International Peace Hospital
Shijiazhuang, Hebei
Siping first people's hospital
Siping, Jilin
Armed police foreces'hospital of Tianjin
Tianjin, Tianjin Municipality
The 254th of PLA
Tianjin, Tianjin Municipality
The 206th of PLA
Tonghua, Jilin
The people's hospital of Tonghua
Tonghua, Jilin
Tonghua central hospital
Tonghua, Jilin
General hospital of Wulumuqi
Ürümqi, Xinjiang
The Chest Hospital of Xinjiang Uyghur Autonomous Region
Ürümqi, Xinjiang
Wuhan Asia heart hospital
Wuhan, Hubei
Tangdu hospital
Xi'an, Shaanxi
The 174th Hospital of PLA
Xiamen, Fujian
General hospital of Ningxia Medical University
Yinchuan, Ningxia
Yingkou Development Zone Hospital
Yingkou, Liaoning
The 4th public hospital of Honghe
Yisa, Yunnan
Yuncheng central hospital
Yuncheng, Shanxi
The 251st of PLA
Zhangjiakou, Hebei
The People's Hospital of Zhecheng County
Zhecheng Chengguanzhen, Henan
The First Hospital of Organization Directly Under Henan Province
Zhengzhou, Henan
Zhuhai people's hospital
Zhuhai, Guangdong
Wanjie Hospital
Zibo, Shandong
About this study
Antiplatelet therapy is the cornerstone for the prevention of atherothrombosis in patients with coronary artery disease (CAD). However, the efficacy and safety of antiplatelet therapy are varied due to ethnic and/or individual variability. The aim of the OPT-CAD study was to demonstrate contemporary status and outcomes of antiplatelet therapy in Chinese CAD patients, and to explore predictors of ischemic or bleeding events in such cohort.Patients above 18 years old who were diagnosed as CAD and received antiplatelet therapy were prospectively enrolled in this national wide, non-intervention registry. All medications and laboratory tests were physician discretion.
Read the detailed description
Antiplatelet therapy is the cornerstone for the prevention of atherothrombosis in patients with coronary artery disease (CAD). However, the efficacy and safety of antiplatelet therapy are varied due to ethnic and/or individual variability. The aim of the OPT-CAD study was to demonstrate contemporary status and outcomes of antiplatelet therapy in Chinese CAD patients, and to explore predictors of ischemic or bleeding events in such cohort.Patients above 18 years who were diagnosed as CAD and received antiplatelet therapy were prospectively enrolled in this national wide, non-intervention registry. All medications and laboratory tests were at physician discretion.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, antiplatelet therapy
- Medical subject headings
- Coronary Artery Disease
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 |
|---|---|---|
| Antiplatelet therapy | patients with coronary artery disease receiving any antiplatelet therapy, without any intervention by the investigators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerebral events
a composite of all cause death, myocardial infarction, stroke or any revascularization or stroke
Measured: 12month
Secondary outcomes (8)
all cause death
Measured: 12month
Stent thrombosis
by BARC definition
Measured: 12 month
rehospitalization
any rehospitalization for cardiac or noncardiac reasons
Measured: 12 month
any bleeding events
by BARC definition
Measured: 12 month
recurrent angina
Measured: 12 month
myocardial infarction
Measured: 12 months
stroke
Measured: 12 months
any revascularization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- 14,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
- Investigators
- Yaling Han, MD, Principal investigator, Shenyang Military Region General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735305
- Sponsor's protocol ID
- SYNH-20121113
- Acronym
- OPT-CAD
- Status last verified
- Dec 2015
- First submitted
- 12 Nov 2012
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jiang Z, Liu H, Qiu M, Li J, Zhao W, Zhang D, Liu D, Na K, Li Y, Han Y. Long-term outcomes in patients with acute coronary syndrome undergoing percutaneous coronary intervention without standard modifiable cardiovascular risk factors: findings from the OPT-CAD cohort. BMC Med. 2025 Feb 24;23(1):112. doi: 10.1186/s12916-025-03933-2.
PubMed 39988674Ma S, Jiang Z, Qiu M, Li Z, Bian L, Li Y, Han Y. Dual Antiplatelet Therapy Duration in Medically Managed Acute Coronary Syndrome Patients: Sub-Analysis of the OPT-CAD Study. Adv Ther. 2020 Jul;37(7):3150-3161. doi: 10.1007/s12325-020-01376-0. Epub 2020 May 16.
PubMed 32418142Feng YQ, He XY, Song FE, Chen JY. Association between Contrast Media Volume and 1-Year Clinical Outcomes in Patients Undergoing Coronary Angiography. Chin Med J (Engl). 2018 Oct 20;131(20):2424-2432. doi: 10.4103/0366-6999.243563.
PubMed 30334527
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Antiplatelet Therapy for Chinese Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01735305
- Acronym / sponsor ID
- OPT-CAD / SYNH-20121113
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, antiplatelet therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,032 participants (actual)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Nov 2012 (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.
Antiplatelet therapy is the cornerstone for the prevention of atherothrombosis in patients with coronary artery disease (CAD). However, the efficacy and safety of antiplatelet therapy are varied due to ethnic and/or individual variability. The aim of the OPT-CAD study was to demonstrate contemporary status and outcomes of antiplatelet therapy in Chinese CAD patients, and to explore predictors of ischemic or bleeding events in such cohort.Patients above 18 years old who were diagnosed as CAD and received antiplatelet therapy were prospectively enrolled in this national wide, non-intervention registry. All medications and laboratory tests were physician discretion.
Detailed description
Antiplatelet therapy is the cornerstone for the prevention of atherothrombosis in patients with coronary artery disease (CAD). However, the efficacy and safety of antiplatelet therapy are varied due to ethnic and/or individual variability. The aim of the OPT-CAD study was to demonstrate contemporary status and outcomes of antiplatelet therapy in Chinese CAD patients, and to explore predictors of ischemic or bleeding events in such cohort.Patients above 18 years who were diagnosed as CAD and received antiplatelet therapy were prospectively enrolled in this national wide, non-intervention registry. All medications and laboratory tests were at physician discretion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antiplatelet therapy | – | –patients with coronary artery disease receiving any antiplatelet therapy, without any intervention by the investigators. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient of coronary heart disease receiving any antiplatelet therapy
Key inclusion criteria (4 listed)
- Clinical diagnosis of coronary heart disease
- Age >= 18 years old
- receiving any antiplatelet agents
- Informed written consent signed
Key exclusion criteria (3 listed)
- With severe disease and life expectancy for 6 months or less
- Difficult to attain follow-up situations judged by researchers (travel, speech or mental disorder, etc.)
- Taking part in an interventional clinical research
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
Major adverse cardiac and cerebral events
Time frame: 12month
a composite of all cause death, myocardial infarction, stroke or any revascularization or stroke
8 secondary outcomes
all cause death
Time frame: 12month
Stent thrombosis
Time frame: 12 month
rehospitalization
Time frame: 12 month
any bleeding events
Time frame: 12 month
recurrent angina
Time frame: 12 month
myocardial infarction
Time frame: 12 months
stroke
Time frame: 12 months
any revascularization
Time frame: 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 11 Dec 2015.
- Derived from this study: PubMed 39988674Jiang Z, Liu H, Qiu M, Li J, Zhao W, Zhang D, Liu D, Na K, Li Y, Han Y. Long-term outcomes in patients with acute coronary syndrome undergoing percutaneous coronary intervention without standard modifiable cardiovascular risk factors: findings from the OPT-CAD cohort. BMC Med. 2025 Feb 24;23(1):112. doi: 10.1186/s12916-025-03933-2.
- Derived from this study: PubMed 32418142Ma S, Jiang Z, Qiu M, Li Z, Bian L, Li Y, Han Y. Dual Antiplatelet Therapy Duration in Medically Managed Acute Coronary Syndrome Patients: Sub-Analysis of the OPT-CAD Study. Adv Ther. 2020 Jul;37(7):3150-3161. doi: 10.1007/s12325-020-01376-0. Epub 2020 May 16.
- Derived from this study: PubMed 30334527Feng YQ, He XY, Song FE, Chen JY. Association between Contrast Media Volume and 1-Year Clinical Outcomes in Patients Undergoing Coronary Angiography. Chin Med J (Engl). 2018 Oct 20;131(20):2424-2432. doi: 10.4103/0366-6999.243563.
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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.
Yaling Han, MD principal investigator
Shenyang Military Region General Hospital
107 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Shenyang Northern Hospital at 107 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 3 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 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 107 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?
Major adverse cardiac and cerebral events (time frame: 12month). 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 NCT01735305, which also lists 3 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 11 Dec 2015.