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

Acute Coronary Syndrome Clinical Trial

— EASY-CHINA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01271101
• Other study ID #: EASY-CHINA
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2011
• Last updated: January 5, 2011
• Start date: July 2010
• Est. completion date: August 2011

Study information

• Verified date: July 2010
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: August 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
China	School of Public Health, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the composite of death, MI, refractory ischemia, or stroke and the major bleeding		9 days	Yes
Secondary	the composite of death, MI, refractory ischemia, or stroke		30 days	No