- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01735305
Optimal Antiplatelet Therapy for Chinese Patients With Coronary Artery Disease (OPT-CAD)
December 10, 2015 updated by: Han Yaling, Shenyang Northern Hospital
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
14032
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Anhui
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Bengbu, Anhui, China
- The First Affiliated Hospital of Bengbu Medical college
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Beijing
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Beijin, Beijing, China
- Beijing Fuwai Hospital
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Beijing, Beijing, China
- Beijing Anzhen Hospital
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Beijing, Beijing, China
- Navy General Hospital
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Beijing, Beijing, China
- The 304th Hospital of PLA
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Beijing, Beijing, China
- The 306th of PLA
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Beijing, Beijing, China
- The Luhe Teaching Hospital of the Capital Medical University
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Beijing, Beijing, China
- The People's Hospital of Beijing University
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Beijing, Beijing, China
- Yanshan hospital
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Chongqing
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Chongqing, Chongqing, China
- Third Military Medical University Xinqiao Hospital
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Fujian
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Xiamen, Fujian, China
- The 174th Hospital of PLA
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Gansu
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Lanzhou, Gansu, China
- Lanzhou military region general hospital
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Guangdong
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Guangdong, Guangdong, China
- The First Affiliated Hospital of Guangzhou Medical College
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Guangzhou, Guangdong, China
- Guangdong General Hospital
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Guangzhou, Guangdong, China
- General hospital of armed police foreces in Guangzhou
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Guangzhou, Guangdong, China
- Guangzhou Baiyun district hospital
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Guangzhou, Guangdong, China
- Guangzhou military region general hospital
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Guangzhou, Guangdong, China
- Guangzhou Panyu district central hospital
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Guangzhou, Guangdong, China
- Liwan District People's Hospital of Guangzhou
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Guangzhou, Guangdong, China
- The first hospital of Guangzhou
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Shenzhen, Guangdong, China
- Shenzhen Longgang center hospital
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Zhuhai, Guangdong, China
- Zhuhai People's Hospital
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Guangxi
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Nanning, Guangxi, China
- The 3rd people's hospital of Nanning
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Guizhou
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Guiyang, Guizhou, China
- Guizhou Provincial People's Hospital
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Hainan
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Sanya, Hainan, China
- The 425th of PLA
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Hebei
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Handan, Hebei, China
- Affiliated Hospital of Hebei University of Engineering
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Rongcheng, Hebei, China
- the People's Hospital of Rongcheng
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Shijiazhuang, Hebei, China
- Bethune International Peace Hospital
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Tangxian, Hebei, China
- The People's Hospital of Tangxian
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Zhangjiakou, Hebei, China
- The 251st of PLA
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Heilongjiang
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Daqing, Heilongjiang, China
- Daqing Oil Field Hospital
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Harbin, Heilongjiang, China
- Heilongjiang Provincial Hospital
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Harbin, Heilongjiang, China
- The 211st of PLA
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Qiqihar, Heilongjiang, China
- The Third Affiliated Hospital of Qiqihar Medical University
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Henan
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Hebi, Henan, China
- The People's Hospital of Hebi
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Pingdingshan, Henan, China
- The 152nd Hospital of PLA
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Zhecheng, Henan, China
- The People's Hospital of Zhecheng County
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Zhengzhou, Henan, China
- The First Hospital of Organization Directly Under Henan Province
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Hubei
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Wuhan, Hubei, China
- Wuhan Asia Heart Hospital
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Hunan
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Changshan, Hunan, China
- The first hospital of Changshan
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Inner Mongolia
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Holingol, Inner Mongolia, China
- The general hospital of Xilingol League
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Jiangsu
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Nanjing, Jiangsu, China
- The First Hospital of Nanjing
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Nantong, Jiangsu, China
- The central hospital of Nantong
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Jiangxi
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Ji'an, Jiangxi, China
- The Affiliated Hospital of Jinggangshan University
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Jilin
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Changchun, Jilin, China
- Central Hospital of Changchun
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Changchun, Jilin, China
- The Affiliated Hospital To Changchun University of Chinese Medicine
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Changchun, Jilin, China
- The China-Japan union hospital of Jilin University
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Changchun, Jilin, China
- The First Affiliated Hospital of Jilin University
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Changchun, Jilin, China
- The Second Affiliated Hospital of Jilin University
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Jilin, Jilin, China
- The 222nd of PLA
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Meihekou, Jilin, China
- Meihekou Central Hospital
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Siping, Jilin, China
- Siping first people's hospital
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Tonghua, Jilin, China
- Tonghua Central Hospital
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Tonghua, Jilin, China
- The 206th of PLA
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Tonghua, Jilin, China
- The people's hospital of Tonghua
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Liaoning
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Anshan, Liaoning, China
- Anshan Central Hospital
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Anshan, Liaoning, China
- Anshan hospital affiliated of China Medical University
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Anshan, Liaoning, China
- The first affiliated hospital of Liaoning Medical University
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Anshan, Liaoning, China
- The people's hospital of Xiuyan
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Anshan, Liaoning, China
- The third hospital of Anshan
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Dalian, Liaoning, China
- Dalian Municipal Central Hospital Affiliated of Dalian Medical University
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Dalian, Liaoning, China
- The 210th Hospital of PLA
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Dalian, Liaoning, China
- Zhongshan Hospital Affiliated to Dalian University
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Dandong, Liaoning, China
- The 230th of PLA
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Dandong, Liaoning, China
- The people's hospital of Dandong
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Fengtian, Liaoning, China
- Central Hospital Affiliated to Shenyang Medical College
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Fushun, Liaoning, China
- Fushun central hospital
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Fushun, Liaoning, China
- The 7th hospital of China Medical University
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Fuxin, Liaoning, China
- The Second Affiliated and gynecology and obstetirs hospital of Fuxin city
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Haicheng, Liaoning, China
- The people's hospital of Haicheng
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Jinzhou, Liaoning, China
- The 205th of PLA
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Jinzhou, Liaoning, China
- The Third Affiliated Hospital of Liaoning Medical College
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Liaoyang, Liaoning, China
- Central hospital of Liaoyang
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Liaoyang, Liaoning, China
- Liaoyang Chemical General Hospital
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Liaoyang, Liaoning, China
- The 201th Hospital of PLA
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Liaoyang, Liaoning, China
- The 2nd people's hospital of Liaoyang
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Shenyang, Liaoning, China
- The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
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Shenyang, Liaoning, China
- Jinqiu Hospital
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Shenyang, Liaoning, China
- Liaoning northern hospital
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Shenyang, Liaoning, China
- Shenyang the forth hospital of people
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Shenyang, Liaoning, China
- The 202nd Hospital of PLA
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Shenyang, Liaoning, China
- The 242nd of PLA
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Shenyang, Liaoning, China
- The 245th of PLA
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Shenyang, Liaoning, China
- The 463rd Hospital of PLA
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Shenyang, Liaoning, China
- The First People's Hospital of Shenyang
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Shenyang, Liaoning, China
- The Forth affiliated hospital of Liaoning University of Traditional Chinese Medicine
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Shenyang, Liaoning, China
- The Second Affiliated Hospital of Shenyang Medical College
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Shenyang, Liaoning, China
- The Third Affiliated Hospital of Shenyang Medical College
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Shenyang, Liaoning, China
- Traditional Chinese Medicine hospital of Shenyang
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Yingkou, Liaoning, China
- Yingkou Development Zone Hospital
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Ningxia
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Yinchuan, Ningxia, China
- General Hospital of Ningxia Medical University
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Qinghai
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Huzhu, Qinghai, China
- The people's hospital of Huzhu
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Shaanxi
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Xi'an, Shaanxi, China
- Tangdu Hospital
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Shandong
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Jinan, Shandong, China
- Jinan Military General Hospital
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Qingdao, Shandong, China
- Jiaozhou central hospital
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Zibo, Shandong, China
- Wanjie Hospital
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Shanghai
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Shanghai, Shanghai, China
- Eastern hospital in Shanghai
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Shanxi
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Yuncheng, Shanxi, China
- Yuncheng Central Hospital
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Sichuan
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Chengdu, Sichuan, China
- Sichuan military general hospital
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Tianjin
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Tianjin, Tianjin, China
- Armed police foreces'hospital of Tianjin
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Tianjin, Tianjin, China
- The 254th of PLA
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Tibet
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Lasa, Tibet, China
- Xizang military general hospital
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Xinjiang
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Ili, Xinjiang, China
- The 11st of PLA
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Urumqi, Xinjiang, China
- General hospital of Wulumuqi
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Urumqi, Xinjiang, China
- The Chest Hospital of Xinjiang Uyghur Autonomous Region
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Yunnan
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Honghe, Yunnan, China
- The 4th public hospital of Honghe
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Zhejiang
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Hangzhou, Zhejiang, China
- Hangzhou First People's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient of coronary heart disease receiving any antiplatelet therapy
Description
Inclusion criteria:
- Clinical diagnosis of coronary heart disease
- Age >= 18 years old
- receiving any antiplatelet agents
- Informed written consent signed
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Antiplatelet therapy
patients with coronary artery disease receiving any antiplatelet therapy, without any intervention by the investigators.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiac and cerebral events
Time Frame: 12month
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a composite of all cause death, myocardial infarction, stroke or any revascularization or stroke
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12month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
all cause death
Time Frame: 12month
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12month
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Stent thrombosis
Time Frame: 12 month
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by BARC definition
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12 month
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rehospitalization
Time Frame: 12 month
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any rehospitalization for cardiac or noncardiac reasons
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12 month
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any bleeding events
Time Frame: 12 month
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by BARC definition
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12 month
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recurrent angina
Time Frame: 12 month
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12 month
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myocardial infarction
Time Frame: 12 months
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12 months
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stroke
Time Frame: 12 months
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12 months
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any revascularization
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yaling Han, MD, Shenyang Military Region General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ma 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. Erratum In: Adv Ther. 2020 Jun 9;:
- Feng 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
November 12, 2012
First Submitted That Met QC Criteria
November 27, 2012
First Posted (Estimate)
November 28, 2012
Study Record Updates
Last Update Posted (Estimate)
December 11, 2015
Last Update Submitted That Met QC Criteria
December 10, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYNH-20121113
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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