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

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

    • Anhui
      • Bengbu, Anhui, China
        • The First Affiliated Hospital of Bengbu Medical college
    • Beijing
      • Beijin, Beijing, China
        • Beijing Fuwai Hospital
      • Beijing, 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
    • Chongqing
      • Chongqing, Chongqing, China
        • Third Military Medical University Xinqiao Hospital
    • Fujian
      • Xiamen, Fujian, China
        • The 174th Hospital of PLA
    • Gansu
      • Lanzhou, Gansu, China
        • Lanzhou military region general hospital
    • Guangdong
      • Guangdong, Guangdong, China
        • The First Affiliated Hospital of Guangzhou Medical College
      • Guangzhou, Guangdong, China
        • Guangdong General Hospital
      • Guangzhou, Guangdong, China
        • General hospital of armed police foreces in Guangzhou
      • 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
      • Shenzhen, Guangdong, China
        • Shenzhen Longgang center hospital
      • Zhuhai, Guangdong, China
        • Zhuhai People's Hospital
    • Guangxi
      • Nanning, Guangxi, China
        • The 3rd people's hospital of Nanning
    • Guizhou
      • Guiyang, Guizhou, China
        • Guizhou Provincial People's Hospital
    • Hainan
      • Sanya, Hainan, China
        • The 425th of PLA
    • Hebei
      • Handan, Hebei, China
        • Affiliated Hospital of Hebei University of Engineering
      • Rongcheng, Hebei, China
        • the People's Hospital of Rongcheng
      • Shijiazhuang, Hebei, China
        • Bethune International Peace Hospital
      • Tangxian, Hebei, China
        • The People's Hospital of Tangxian
      • Zhangjiakou, Hebei, China
        • The 251st of PLA
    • Heilongjiang
      • Daqing, Heilongjiang, China
        • Daqing Oil Field Hospital
      • Harbin, Heilongjiang, China
        • Heilongjiang Provincial Hospital
      • Harbin, Heilongjiang, China
        • The 211st of PLA
      • Qiqihar, Heilongjiang, China
        • The Third Affiliated Hospital of Qiqihar Medical University
    • Henan
      • Hebi, Henan, China
        • The People's Hospital of Hebi
      • Pingdingshan, Henan, China
        • The 152nd Hospital of PLA
      • Zhecheng, Henan, China
        • The People's Hospital of Zhecheng County
      • Zhengzhou, Henan, China
        • The First Hospital of Organization Directly Under Henan Province
    • Hubei
      • Wuhan, Hubei, China
        • Wuhan Asia Heart Hospital
    • Hunan
      • Changshan, Hunan, China
        • The first hospital of Changshan
    • Inner Mongolia
      • Holingol, Inner Mongolia, China
        • The general hospital of Xilingol League
    • Jiangsu
      • Nanjing, Jiangsu, China
        • The First Hospital of Nanjing
      • Nantong, Jiangsu, China
        • The central hospital of Nantong
    • Jiangxi
      • Ji'an, Jiangxi, China
        • The Affiliated Hospital of Jinggangshan University
    • Jilin
      • Changchun, Jilin, 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
      • Jilin, Jilin, China
        • The 222nd of PLA
      • Meihekou, Jilin, China
        • Meihekou Central Hospital
      • Siping, Jilin, China
        • Siping first people's hospital
      • Tonghua, Jilin, China
        • Tonghua Central Hospital
      • Tonghua, Jilin, China
        • The 206th of PLA
      • Tonghua, Jilin, China
        • The people's hospital of Tonghua
    • Liaoning
      • Anshan, Liaoning, 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
      • Dalian, Liaoning, 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
      • Dandong, Liaoning, China
        • The 230th of PLA
      • Dandong, Liaoning, China
        • The people's hospital of Dandong
      • Fengtian, Liaoning, China
        • Central Hospital Affiliated to Shenyang Medical College
      • Fushun, Liaoning, China
        • Fushun central hospital
      • Fushun, Liaoning, China
        • The 7th hospital of China Medical University
      • Fuxin, Liaoning, China
        • The Second Affiliated and gynecology and obstetirs hospital of Fuxin city
      • Haicheng, Liaoning, China
        • The people's hospital of Haicheng
      • Jinzhou, Liaoning, China
        • The 205th of PLA
      • Jinzhou, Liaoning, China
        • The Third Affiliated Hospital of Liaoning Medical College
      • Liaoyang, Liaoning, 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
      • Shenyang, Liaoning, China
        • The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
      • Shenyang, Liaoning, 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 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
      • Yingkou, Liaoning, China
        • Yingkou Development Zone Hospital
    • Ningxia
      • Yinchuan, Ningxia, China
        • General Hospital of Ningxia Medical University
    • Qinghai
      • Huzhu, Qinghai, China
        • The people's hospital of Huzhu
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Tangdu Hospital
    • Shandong
      • Jinan, Shandong, China
        • Jinan Military General Hospital
      • Qingdao, Shandong, China
        • Jiaozhou central hospital
      • Zibo, Shandong, China
        • Wanjie Hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Eastern hospital in Shanghai
    • Shanxi
      • Yuncheng, Shanxi, China
        • Yuncheng Central Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • Sichuan military general hospital
    • Tianjin
      • Tianjin, Tianjin, China
        • Armed police foreces'hospital of Tianjin
      • Tianjin, Tianjin, China
        • The 254th of PLA
    • Tibet
      • Lasa, Tibet, China
        • Xizang military general hospital
    • Xinjiang
      • Ili, Xinjiang, China
        • The 11st of PLA
      • Urumqi, Xinjiang, China
        • General hospital of Wulumuqi
      • Urumqi, Xinjiang, China
        • The Chest Hospital of Xinjiang Uyghur Autonomous Region
    • Yunnan
      • Honghe, Yunnan, China
        • The 4th public hospital of Honghe
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Hangzhou First People's Hospital

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:

  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 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
Antiplatelet therapy
patients with coronary artery disease receiving any antiplatelet therapy, without any intervention by the investigators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac and cerebral events
Time Frame: 12month
a composite of all cause death, myocardial infarction, stroke or any revascularization or stroke
12month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all cause death
Time Frame: 12month
12month
Stent thrombosis
Time Frame: 12 month
by BARC definition
12 month
rehospitalization
Time Frame: 12 month
any rehospitalization for cardiac or noncardiac reasons
12 month
any bleeding events
Time Frame: 12 month
by BARC definition
12 month
recurrent angina
Time Frame: 12 month
12 month
myocardial infarction
Time Frame: 12 months
12 months
stroke
Time Frame: 12 months
12 months
any revascularization
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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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