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

Primary Purpose

Acute Coronary Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Atorvastatin

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome, intensive lipid-lowering, statins

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Second Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

intensive statin group

moderate statin group

Outcomes

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00728013

First Posted

July 29, 2008

Last Updated

August 22, 2008

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00728013

Brief Title

China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

Acronym

CHILLAS

Official Title

China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Unknown status

Study Start Date

December 2006 (undefined)

Primary Completion Date

December 2008 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

Acute coronary syndrome, intensive lipid-lowering, statins

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

intensive statin group

Arm Title

Arm Type

Experimental

Arm Description

moderate statin group

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

Eligible patients are randomly assigned (1:1 ratio) by center to moderate therapy (atorvastatin, 10 mg/d, or equivalent dose of other statins).

Primary Outcome Measure Information:

Title

Time Frame

2 years

Secondary Outcome Measure Information:

Title

The secondary endpoints include total mortality

Time Frame

2 years

Title

LDL cholesterol success rate

Time Frame

2 years

Title

Percentage rate of plaque regression

Time Frame

2 years

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shuiping Zhao, MD

Organizational Affiliation

Ministry of Education of the People's Republic of China

Official's Role

Study Director

Facility Information:

Facility Name

The Second Xiangya Hospital of Central South University

City

ChangSha

State/Province

Hu Nan

ZIP/Postal Code

410011

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shuiping Zhao, MD,PHD

Phone

86-731-5295806

zhaosp@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Daoquan Peng, MD,PHD

Phone

86-139-748-22567

pengdq@hotmail.com

First Name & Middle Initial & Last Name & Degree

Shuiping Zhao, MD

12. IPD Sharing Statement

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China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

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