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The Efficacy and Safety of Anticoagulation in Chinese Patients With Non-ST Segment Elevation Acute Coronary Syndrome (EASY-CHINA)

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ClinicalTrials.gov Identifier: NCT01271101
Recruitment Status : Unknown
Verified July 2010 by Fudan University.
Recruitment status was:  Recruiting
First Posted : January 6, 2011
Last Update Posted : January 6, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The primary objective of the EASY-CHINA Registry is to describe the clinical epidemiology of Chinese patients with NSTE-ACS, to evaluate their current anticoagulation management in China, and the resources used for it.

Condition or disease
Acute Coronary Syndrome

Detailed Description:
Non-ST-elevated acute coronary syndromes (NSTE-ACS)are the leading cause of emergency medical care in the USA. In China, these syndromes have also become the major causes of morbidity and mortality and account for several thousands of death and hospitalizations annually. Anti-platelet drugs, anticoagulants and intervention therapy for high-risk NSTE-ACS patients may increase bleeding events while reducing ischemic coronary events. There are some evidences supporting the association between hemorrhagic complications and short- and long-term mortality. Therefore, future advances in antithrombotic therapy for NSTE-ACS need to focus on reducing ischemic event rates without increasing hemorrhagic complication rates. In this general framework, there is the need for an appropriate adoption of the available evidences concerning therapeutic strategies, specifically the use of the different antithrombotic strategies, in real world patients in order to further improve their outcomes.The primary objective of this study is to describe the clinical epidemiology of Chinese patients with NSTE-ACS, and to evaluate their current management in China. This study will be an observational survey, thus zero interference is emphasized throughout it. No randomization, blinding or special treatment will be assigned for the subjects. Issues concerning the care of subjects are completely left to the discretion of investigators in order to collect the real-world information about the pharmacological treatments for NSTE-ACS patients in china.

Study Design

Study Type : Observational
Estimated Enrollment : 1800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Efficacy and Safety of Anticoagulation in Chinese Patients With Non-ST Segment Elevation Acute Coronary Syndrome
Study Start Date : July 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : August 2011
Groups and Cohorts

Group/Cohort
anticoagulant


Outcome Measures

Primary Outcome Measures :
  1. the composite of death, MI, refractory ischemia, or stroke and the major bleeding [ Time Frame: 9 days ]

Secondary Outcome Measures :
  1. the composite of death, MI, refractory ischemia, or stroke [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese patients with non-ST-elevated acute coronary syndrome
Criteria

Inclusion Criteria:

  • with symptoms of UA or MI without persistent ST elevation and at least 1 of the following additional criterias: 1)troponin T or I or CK-MB above the upper limit of normal,2)electrocardiogram (ECG) changes compatible with ischemia (ie, ST depression at least 1mm in 2 contiguous leads or T-wave inversion >3 mm),3)any dynamic ST shift or transient ST elevation
  • Must be willing to signed informed consent
  • age from 21-80 years
  • without pregnancy or under contraception

Exclusion Criteria:

  • age<20 or >80 years
  • any contraindication to anticoagulant
  • hemorrhagic stroke within 12 months
  • indication for anticoagulation other than ACS
  • prior enrollment in anticoagulants trials in ACS
  • revascularization procedure performed for the qualifying event in one month
  • severe renal insufficiency (ie,serum creatinine>=3 mg/dL or 265umol/L)
  • pregnancy or breast-feeding women
  • life expectancy<6 months
  • enrollment in other medicine trials in 3 months
  • with mental illness or uncooperative
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271101


Locations
China, Shanghai
School of Public Health, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jinming Yu, Doctor    +86-21-54237868    jmy@fudan.edu.cn   
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jinming Yu, Doctor School of Public Health, Fudan University
More Information

Responsible Party: Jinming Yu, School of Public Health, Fudan University
ClinicalTrials.gov Identifier: NCT01271101     History of Changes
Other Study ID Numbers: EASY-CHINA
First Posted: January 6, 2011    Key Record Dates
Last Update Posted: January 6, 2011
Last Verified: July 2010

Keywords provided by Fudan University:
Non-ST-elevated acute coronary syndromes (NSTE-ACS)
anticoagulation

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases