Clinical trial NCT01271101: The Efficacy and Safety of Anticoagulation in Chinese Patients With Non-ST Segment Elevation Acute Coronary Syndrome
Official title: The Efficacy and Safety of Anticoagulation in Chinese Patients With Non-ST Segment Elevation Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Keywords: Non-ST-elevated acute coronary syndromes (NSTE-ACS)
anticoagulation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2011-01-06
Enrollment: 1800
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese patients with non-ST-elevated acute coronary syndrome

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.

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.

Eligibility 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

Primary outcomes:
measure: the composite of death, MI, refractory ischemia, or stroke and the major bleeding
timeFrame: 9 days
Secondary outcomes:
measure: the composite of death, MI, refractory ischemia, or stroke
timeFrame: 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: School of Public Health, Fudan University
state: Shanghai
Study officials:
affiliation: School of Public Health，Fudan University
name: Jinming Yu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: