Optimal Antiplatelet Therapy for Chinese Patients With Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— OPT-CAD  

Official title:

Optimal Antiplatelet Therapy for Chinese Patients With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735305
• Other study ID #: SYNH-20121113
• Status: Completed
• Phase: N/A
• First received: November 12, 2012
• Last updated: December 10, 2015
• Start date: November 2012
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14032
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Shenyang Northern Hospital	Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac and cerebral events	a composite of all cause death, myocardial infarction, stroke or any revascularization or stroke	12month	Yes
Secondary	all cause death		12month	Yes
Secondary	Stent thrombosis	by BARC definition	12 month	Yes
Secondary	rehospitalization	any rehospitalization for cardiac or noncardiac reasons	12 month	Yes
Secondary	any bleeding events	by BARC definition	12 month	Yes
Secondary	recurrent angina		12 month	No
Secondary	myocardial infarction		12 months	Yes
Secondary	stroke		12 months	Yes
Secondary	any revascularization		12 months	No