China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

NCT00728013 | Unknown DMC

• 1 other identifier: 2006BAI01A02-12
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndrome; intensive lipid-lowering; statins

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• The secondary endpoints include total mortality

  2 years

• LDL cholesterol success rate

  2 years

• Percentage rate of plaque regression

  2 years

• In addition, changes in CRP from baseline to specified measurement time points will be calculated

  2 years

Study Arms (2)

A

EXPERIMENTAL

intensive statin group

Drug: Atorvastatin

B

EXPERIMENTAL

moderate statin group

Drug: Atorvastatin

Interventions

Atorvastatin 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)

A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of acute coronary syndrome
• Clinically stable for 24 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Science and Technology of the People´s Republic of China: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Shuiping Zhao, MD

  Ministry of Education of the People's Republic of China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: August 5, 2008
• Study Start: December 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2010
• Last Updated: August 25, 2008

Record last verified: 2008-08

Locations

CN (1)