Clinical Trial: China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Ministry of Science and Technology of the People´s Republic of China

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: 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 ]

Information By: Ministry of Science and Technology of the People´s Republic of China

Dates:
Date Received: July 29, 2008
Date Started: December 2006
Date Completion: December 2010
Last Updated: August 22, 2008
Last Verified: August 2008