Clinical trial NCT01735305: Optimal Antiplatelet Therapy for Chinese Patients With Coronary Artery Disease
Official title: Optimal Antiplatelet Therapy for Chinese Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
antiplatelet therapy
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
First posted: 2012-11-28
Enrollment: 14032
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient of coronary heart disease receiving any antiplatelet therapy

Brief 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. 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.

Eligibility criteria: Inclusion criteria:

1. Clinical diagnosis of coronary heart disease
2. Age \>= 18 years old
3. receiving any antiplatelet agents
4. Informed written consent signed

Exclusion Criteria:

1. With severe disease and life expectancy for 6 months or less
2. Difficult to attain follow-up situations judged by researchers (travel, speech or mental disorder, etc.)
3. Taking part in an interventional clinical research

Primary outcomes:
measure: Major adverse cardiac and cerebral events
timeFrame: 12month
Secondary outcomes:
measure: all cause death
timeFrame: 12month
measure: Stent thrombosis
timeFrame: 12 month
measure: rehospitalization
timeFrame: 12 month
measure: any bleeding events
timeFrame: 12 month
measure: recurrent angina
timeFrame: 12 month
measure: myocardial infarction
timeFrame: 12 months
measure: stroke
timeFrame: 12 months
measure: any revascularization
timeFrame: 12 months
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The first affiliated hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Beijing
country: China
facility: Navy General Hospital
state: Beijing
city: Beijing
country: China
facility: The 304th Hospital of PLA
state: Beijing
city: Beijing
country: China
facility: The 306th of PLA
state: Beijing
city: Beijing
country: China
facility: The Luhe teaching hospital of the Capital Medical University
state: Beijing
city: Beijing
country: China
facility: The People's Hospital of Beijing University
state: Beijing
city: Beijing
country: China
facility: Yanshan hospital
state: Beijing
city: Beijin
country: China
facility: Beijing Fuwai Hospital
state: Beijing
city: Chongqing
country: China
facility: Third Military Medical University Xinqiao Hospital
state: Chongqing
city: Xiamen
country: China
facility: The 174th Hospital of PLA
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou military region general hospital
state: Gansu
city: Guangdong
country: China
facility: The First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
city: Guangzhou
country: China
facility: General hospital of armed police foreces in Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Baiyun district hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou military region general hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Panyu district central hospital
state: Guangdong
city: Guangzhou
country: China
facility: Liwan District People's Hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: The first hospital of Guangzhou
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Longgang center hospital
state: Guangdong
city: Zhuhai
country: China
facility: Zhuhai people's hospital
state: Guangdong
city: Nanning
country: China
facility: The 3rd people's hospital of Nanning
state: Guangxi
city: Guiyang
country: China
facility: Guizhou provincial people's hospital
state: Guizhou
city: Sanya
country: China
facility: The 425th of PLA
state: Hainan
city: Handan
country: China
facility: Affiliated hospital of Hebei University of Engineering
state: Hebei
city: Rongcheng
country: China
facility: The people's hospital of Rongcheng
state: Hebei
city: Shijiazhuang
country: China
facility: Bethune International Peace Hospital
state: Hebei
city: Tangxian
country: China
facility: The People's Hospital of Tangxian
state: Hebei
city: Zhangjiakou
country: China
facility: The 251st of PLA
state: Hebei
city: Daqing
country: China
facility: Daqing oil field hospital
state: Heilongjiang
city: Harbin
country: China
facility: Heilongjiang provincial hospital
state: Heilongjiang
city: Harbin
country: China
facility: The 211st of PLA
state: Heilongjiang
city: Qiqihar
country: China
facility: The third affiliated hospital of Qiqihar Medical University
state: Heilongjiang
city: Hebi
country: China
facility: The People's Hospital of Hebi
state: Henan
city: Pingdingshan
country: China
facility: The 152nd Hospital of PLA
state: Henan
city: Zhecheng
country: China
facility: The People's Hospital of Zhecheng County
state: Henan
city: Zhengzhou
country: China
facility: The First Hospital of Organization Directly Under Henan Province
state: Henan
city: Wuhan
country: China
facility: Wuhan Asia heart hospital
state: Hubei
city: Changshan
country: China
facility: The first hospital of Changshan
state: Hunan
city: Holingol
country: China
facility: The general hospital of Xilingol League
state: Inner Mongolia
city: Nanjing
country: China
facility: The first hospital of Nanjing
state: Jiangsu
city: Nantong
country: China
facility: The central hospital of Nantong
state: Jiangsu
city: Ji'an
country: China
facility: The Affiliated Hospital of Jinggangshan University
state: Jiangxi
city: Changchun
country: China
facility: Central Hospital of Changchun
state: Jilin
city: Changchun
country: China
facility: The affiliated hospital to Changchun University of Chinese Medicine
state: Jilin
city: Changchun
country: China
facility: The China-Japan union hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The First Affiliated Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Affiliated Hospital of Jilin University
state: Jilin
city: Jilin
country: China
facility: The 222nd of PLA
state: Jilin
city: Meihekou
country: China
facility: Meihekou central hospital
state: Jilin
city: Siping
country: China
facility: Siping first people's hospital
state: Jilin
city: Tonghua
country: China
facility: The 206th of PLA
state: Jilin
city: Tonghua
country: China
facility: The people's hospital of Tonghua
state: Jilin
city: Tonghua
country: China
facility: Tonghua central hospital
state: Jilin
city: Anshan
country: China
facility: Anshan central hospital
state: Liaoning
city: Anshan
country: China
facility: Anshan hospital affiliated of China Medical University
state: Liaoning
city: Anshan
country: China
facility: The first affiliated hospital of Liaoning Medical University
state: Liaoning
city: Anshan
country: China
facility: The people's hospital of Xiuyan
state: Liaoning
city: Anshan
country: China
facility: The third hospital of Anshan
state: Liaoning
city: Dalian
country: China
facility: Dalian municipal central hospital affiliated of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: The 210th Hospital of PLA
state: Liaoning
city: Dalian
country: China
facility: Zhongshan Hospital Affiliated to Dalian University
state: Liaoning
city: Dandong
country: China
facility: The 230th of PLA
state: Liaoning
city: Dandong
country: China
facility: The people's hospital of Dandong
state: Liaoning
city: Fengtian
country: China
facility: Central Hospital affiliated to Shenyang Medical College
state: Liaoning
city: Fushun
country: China
facility: Fushun central hospital
state: Liaoning
city: Fushun
country: China
facility: The 7th hospital of China Medical University
state: Liaoning
city: Fuxin
country: China
facility: The Second Affiliated and gynecology and obstetirs hospital of Fuxin city
state: Liaoning
city: Haicheng
country: China
facility: The people's hospital of Haicheng
state: Liaoning
city: Jinzhou
country: China
facility: The 205th of PLA
state: Liaoning
city: Jinzhou
country: China
facility: The third affiliated hospital of Liaoning medical College
state: Liaoning
city: Liaoyang
country: China
facility: Central hospital of Liaoyang
state: Liaoning
city: Liaoyang
country: China
facility: Liaoyang Chemical General Hospital
state: Liaoning
city: Liaoyang
country: China
facility: The 201th Hospital of PLA
state: Liaoning
city: Liaoyang
country: China
facility: The 2nd people's hospital of Liaoyang
state: Liaoning
city: Shenyang
country: China
facility: Jinqiu Hospital
state: Liaoning
city: Shenyang
country: China
facility: Liaoning northern hospital
state: Liaoning
city: Shenyang
country: China
facility: Shenyang the forth hospital of people
state: Liaoning
city: Shenyang
country: China
facility: The 202nd Hospital of PLA
state: Liaoning
city: Shenyang
country: China
facility: The 242nd of PLA
state: Liaoning
city: Shenyang
country: China
facility: The 245th of PLA
state: Liaoning
city: Shenyang
country: China
facility: The 463rd Hospital of PLA
state: Liaoning
city: Shenyang
country: China
facility: The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Shenyang
country: China
facility: The first people's hospital of Shenyang
state: Liaoning
city: Shenyang
country: China
facility: The Forth affiliated hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Shenyang
country: China
facility: The Second Affiliated Hospital of Shenyang Medical College
state: Liaoning
city: Shenyang
country: China
facility: The Third Affiliated Hospital of Shenyang Medical College
state: Liaoning
city: Shenyang
country: China
facility: Traditional Chinese Medicine hospital of Shenyang
state: Liaoning
city: Yingkou
country: China
facility: Yingkou Development Zone Hospital
state: Liaoning
city: Yinchuan
country: China
facility: General hospital of Ningxia Medical University
state: Ningxia
city: Huzhu
country: China
facility: The people's hospital of Huzhu
state: Qinghai
city: Xi'an
country: China
facility: Tangdu hospital
state: Shaanxi
city: Jinan
country: China
facility: Jinan military general hospital
state: Shandong
city: Qingdao
country: China
facility: Jiaozhou central hospital
state: Shandong
city: Zibo
country: China
facility: Wanjie Hospital
state: Shandong
city: Shanghai
country: China
facility: Eastern hospital in Shanghai
state: Shanghai
city: Yuncheng
country: China
facility: Yuncheng central hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan military general hospital
state: Sichuan
city: Tianjin
country: China
facility: Armed police foreces'hospital of Tianjin
state: Tianjin
city: Tianjin
country: China
facility: The 254th of PLA
state: Tianjin
city: Lasa
country: China
facility: Xizang military general hospital
state: Tibet
city: Ili
country: China
facility: The 11st of PLA
state: Xinjiang
city: Urumqi
country: China
facility: General hospital of Wulumuqi
state: Xinjiang
city: Urumqi
country: China
facility: The Chest Hospital of Xinjiang Uyghur Autonomous Region
state: Xinjiang
city: Honghe
country: China
facility: The 4th public hospital of Honghe
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou first people's hospital
state: Zhejiang
Study officials:
affiliation: Shenyang Military Region General Hospital
name: Yaling Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.