China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome - Full Text View

Sponsored by:	Ministry of Science and Technology of the People´s Republic of China
Information provided by:	Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier:	NCT00728013

Purpose

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.

Condition	Intervention
Acute Coronary Syndrome	Drug: Atorvastatin

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Atorvastatin Atorvastatin calcium Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

Further study details as provided by Ministry of Science and Technology of the People´s Republic of China:

Primary Outcome Measures:

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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary endpoints include total mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
LDL cholesterol success rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Percentage rate of plaque regression [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
In addition, changes in CRP from baseline to specified measurement time points will be calculated [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1600
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental intensive statin group	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)
B: Experimental moderate statin group	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).

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728013

Locations

China, Hu Nan
The Second Xiangya Hospital of Central South University	Recruiting
ChangSha, Hu Nan, China, 410011
Contact: Shuiping Zhao, MD,PHD 86-731-5295806 zhaosp@medmail.com.cn
Contact: Daoquan Peng, MD,PHD 86-139-748-22567 pengdq@hotmail.com
Principal Investigator: Shuiping Zhao, MD

Sponsors and Collaborators

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

Investigators

Study Director:

Shuiping Zhao, MD

Ministry of Education of the People's Republic of China

More Information

Responsible Party:	Peking University First Hospital ( Yong Huo )
Study ID Numbers:	2006BAI01A02-12
Study First Received:	July 29, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00728013
Health Authority:	China: Ministry of Health

Keywords provided by Ministry of Science and Technology of the People´s Republic of China:

Acute coronary syndrome
intensive lipid-lowering
statins

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome

Vascular Diseases
Ischemia
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Syndrome
Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009