China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

NCT ID: NCT00728013

Last Updated: 2008-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2010-12-31

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

intensive statin group

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

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)

B

moderate statin group

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

Atorvastatin

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Technology of the People´s Republic of China

OTHER_GOV

Sponsor Role: lead

Responsible Party

Peking University First Hospital

Principal Investigators

Shuiping Zhao, MD

Role: STUDY_DIRECTOR

Ministry of Education of the People's Republic of China

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Shuiping Zhao, MD,PHD

Role: primary

zhaosp@medmail.com.cn

86-731-5295806

Daoquan Peng, MD,PHD

Role: backup

pengdq@hotmail.com

86-139-748-22567

Other Identifiers

2006BAI01A02-12

Identifier Type: -

Identifier Source: org_study_id