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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier:
NCT00728013
First received: July 29, 2008
Last updated: August 22, 2008
Last verified: August 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

Resource links provided by NLM:


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
Experimental: A
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)
Experimental: B
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Yong Huo, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT00728013     History of Changes
Other Study ID Numbers: 2006BAI01A02-12
Study First Received: July 29, 2008
Last Updated: August 22, 2008
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

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014