- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01271101
The Efficacy and Safety of Anticoagulation in Chinese Patients With Non-ST Segment Elevation Acute Coronary Syndrome (EASY-CHINA)
January 5, 2011 updated by: Fudan University
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
1800
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
-
-
Shanghai
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Shanghai, Shanghai, China, 200032
- Recruiting
- School of Public Health, Fudan University
-
Contact:
- Jinming Yu, Doctor
- Phone Number: +86-21-54237868
- Email: jmy@fudan.edu.cn
-
-
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
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Chinese patients with non-ST-elevated acute coronary syndrome
Description
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
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
Cohorts and Interventions
Group / Cohort |
---|
anticoagulant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the composite of death, MI, refractory ischemia, or stroke and the major bleeding
Time Frame: 9 days
|
9 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the composite of death, MI, refractory ischemia, or stroke
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jinming Yu, Doctor, School of Public Health,Fudan University
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
July 1, 2010
Primary Completion (Anticipated)
March 1, 2011
Study Completion (Anticipated)
August 1, 2011
Study Registration Dates
First Submitted
January 5, 2011
First Submitted That Met QC Criteria
January 5, 2011
First Posted (Estimate)
January 6, 2011
Study Record Updates
Last Update Posted (Estimate)
January 6, 2011
Last Update Submitted That Met QC Criteria
January 5, 2011
Last Verified
July 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EASY-CHINA
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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