Clinical trial NCT00728013: China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome
Official title: China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Acute coronary syndrome
intensive lipid-lowering
statins
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
First posted: 2008-08-05
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In summary, the CHILLAS study will be the first multicenter study performed in a Chinese population using a patient-level analysis to compare the effects and safety of intensive statin therapy with that of moderate statin therapy. Therefore, it will determine whether "lower is better", that is, whether LDL cholesterol lowering to a level of approximately 100mg/dl provides a benefit inferior to that of LDL cholesterol lowering to a much lower level; examine the role of inflammatory markers in predicting cardiac events and response to statin therapy; and evaluate the effects of statin therapy on regression of coronary atherosclerosis using IVUS.

Detailed description: The CHILLAS study is planned to evaluate whether intensive treatment with statins for 2 years results in a reduction of cardiovascular events in patients with ACS. A total of 1,600 patients will be randomly assigned to receive intensive statin therapy (atorvastatin, 20 or 40 mg/d, or equivalent dose of other statins) or moderate therapy (atorvastatin, 10 mg/d, or equivalent dose of other statins). Both groups receive dietary counseling. Over a 2-year follow-up period, the primary outcome measure is the time to occurrence of cardiac death, nonfatal acute myocardial infarction, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting, documented unstable angina or severe heart failure requiring emergency hospitalization, and stroke. The planned duration is between December 2006 and December 2009.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute coronary syndrome
* Clinically stable for 24 hours

Exclusion Criteria:

* Hypersensitive to statins
* Receiving therapy with atorvastatin at a dose greater than 20 mg per day before enrollment or lipid-lowering therapy with fibric acid derivatives or niacin that can not be discontinued
* Having a coexisting condition that shortened expected survival to less than two years
* Having obstructive hepatobiliary disease or other serious hepatic or kidney disease
* Having an unexplained elevation in the creatine kinase level that was more than three times the upper limit of normal and that was not related to myocardial infarction
* Having undergone surgery or serious trauma within the preceding two months
* Having been in the final stage of chronic congestive heart failure
* Having a baseline level of LDL cholesterol less than 50mg/dl

Primary outcomes:
measure: Cardiac death, nonfatal AMI, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting, documented unstable angina or severe heart failure requiring emergency rehospitalization, and stroke
timeFrame: 2 years
Secondary outcomes:
measure: The secondary endpoints include total mortality
timeFrame: 2 years
measure: LDL cholesterol success rate
timeFrame: 2 years
measure: Percentage rate of plaque regression
timeFrame: 2 years
measure: In addition, changes in CRP from baseline to specified measurement time points will be calculated
timeFrame: 2 years
Other outcomes:
Locations:
city: ChangSha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hu Nan
Study officials:
affiliation: Ministry of Education of the People's Republic of China
name: Shuiping Zhao, MD
role: STUDY_DIRECTOR
References: