China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— CHILLAS  

Official title:

China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00728013
• Other study ID #: 2006BAI01A02-12
• Status: Recruiting
• Phase: N/A
• First received: July 29, 2008
• Last updated: August 22, 2008
• Start date: December 2006
• Est. completion date: December 2010

Study information

• Verified date: August 2008
• Source: Ministry of Science and Technology of the People´s Republic of China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: December 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Atorvastatin
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)
• Atorvastatin
Eligible patients are randomly assigned (1:1 ratio) by center to moderate therapy (atorvastatin, 10 mg/d, or equivalent dose of other statins).

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	ChangSha	Hu Nan

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The secondary endpoints include total mortality		2 years	Yes
Secondary	LDL cholesterol success rate		2 years	Yes
Secondary	Percentage rate of plaque regression		2 years	Yes
Secondary	In addition, changes in CRP from baseline to specified measurement time points will be calculated		2 years	Yes