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Optimal Antiplatelet Therapy for Chinese Patients With Coronary Artery Disease (OPT-CAD)

This study has been completed.
Sponsor:
Collaborator:
Guangdong General Hospital
Information provided by (Responsible Party):
Han Yaling, Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT01735305
First received: November 12, 2012
Last updated: December 10, 2015
Last verified: December 2015
  Purpose
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.

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimal Antiplatelet Therapy for Chinese Patients With Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Shenyang Northern Hospital:

Primary Outcome Measures:
  • Major adverse cardiac and cerebral events [ Time Frame: 12month ] [ Designated as safety issue: Yes ]
    a composite of all cause death, myocardial infarction, stroke or any revascularization or stroke


Secondary Outcome Measures:
  • all cause death [ Time Frame: 12month ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    by BARC definition

  • rehospitalization [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    any rehospitalization for cardiac or noncardiac reasons

  • any bleeding events [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    by BARC definition

  • recurrent angina [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • stroke [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • any revascularization [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 14032
Study Start Date: November 2012
Study Completion Date: March 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Antiplatelet therapy
patients with coronary artery disease receiving any antiplatelet therapy, without any intervention by the investigators.

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

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient of coronary heart disease receiving any antiplatelet therapy
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735305

  Show 107 Study Locations
Sponsors and Collaborators
Shenyang Northern Hospital
Guangdong General Hospital
Investigators
Principal Investigator: Yaling Han, MD Shenyang Military Region General Hospital
  More Information

Responsible Party: Han Yaling, Dr, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT01735305     History of Changes
Other Study ID Numbers: SYNH-20121113 
Study First Received: November 12, 2012
Last Updated: December 10, 2015
Health Authority: China: Ministry of Health

Keywords provided by Shenyang Northern Hospital:
Coronary Artery Disease
antiplatelet therapy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 30, 2016