China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

Study Overview
=================
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.

Official Title
-----------------
China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: Atorvastatin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>intensive statin group | Drug: Atorvastatin<br>* Eligible patients are randomly assigned (1:1 ratio) by center to intensive statin therapy (atorvastatin, 20 or 40 mg/d, or equivalent dose of other statins)<br>|
| Experimental: B<br>moderate statin group | Drug: Atorvastatin<br>* Eligible patients are randomly assigned (1:1 ratio) by center to moderate therapy (atorvastatin, 10 mg/d, or equivalent dose of other statins).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoints include total mortality |  | 2 years | 
| LDL cholesterol success rate |  | 2 years | 
| Percentage rate of plaque regression |  | 2 years | 
| In addition, changes in CRP from baseline to specified measurement time points will be calculated |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute coronary syndrome, intensive lipid-lowering, statins