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China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome (CHILLAS)

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ClinicalTrials.gov Identifier: NCT00728013
Recruitment Status : Unknown
Verified August 2008 by Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was:  Recruiting
First Posted : August 5, 2008
Last Update Posted : August 25, 2008
Sponsor:
Information provided by:

July 29, 2008
August 5, 2008
August 25, 2008
December 2006
December 2008   (Final data collection date for primary outcome 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 [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00728013 on ClinicalTrials.gov Archive Site
  • The secondary endpoints include total mortality [ Time Frame: 2 years ]
  • LDL cholesterol success rate [ Time Frame: 2 years ]
  • Percentage rate of plaque regression [ Time Frame: 2 years ]
  • In addition, changes in CRP from baseline to specified measurement time points will be calculated [ Time Frame: 2 years ]
The secondary endpoints include total mortality, LDL cholesterol success rate, percentage rate of plaque regression. In addition, changes in CRP from baseline to specified measurement time points will be calculated. [ Time Frame: 2 years ]
Not Provided
Not Provided
 
China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome
China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Coronary Syndrome
  • 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)
  • 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).
  • Experimental: A
    intensive statin group
    Intervention: Drug: Atorvastatin
  • Experimental: B
    moderate statin group
    Intervention: Drug: Atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1600
December 2010
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00728013
2006BAI01A02-12
Yes
Not Provided
Not Provided
Yong Huo, Peking University First Hospital
Ministry of Science and Technology of the People´s Republic of China
Not Provided
Study Director: Shuiping Zhao, MD Ministry of Education of the People's Republic of China
Ministry of Science and Technology of the People´s Republic of China
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP