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NCT00723320 Clinical Trial

Effect of Atorvastatin and Lifestyle Intervention on Progression of Pre-Clinical Atherosclerosis

Atherosclerosis Clinical Trial

— EALIPPCA  

Official title:
Effect of Atorvastatin and Lifestyle Intervention on Progression of Carotid Intima-Media Thickness in Chinese People Without Manifest Atherosclerotic Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00723320
Other study ID # 2006BAI01A02-03
Secondary ID
Status Recruiting
Phase N/A
First received July 21, 2008
Last updated August 22, 2008
Start date February 2008
Est. completion date December 2010

Study information
Verified date July 2008
Source Ministry of Science and Technology of the People´s Republic of China
Contact Jianping Li
Phone 86-10-66551122
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether atorvastatin, aggressive lifestyle intervention, and their interaction are effective in delaying the progress of pre-clinical atherosclerosis.

Description:

Primary prevention of atherosclerotic disease remains a big challenge. Currently, it is not clear how to treat those subjects with evidence of pre-clinical atherosclerosis but without obvious conventional risk factors. This randomized, placebo controlled, double blind study is to evaluate the effect of Atorvastatin 10 mg daily, therapeutic lifestyle change, and their combination, on the progression of CIMT in those with higher baseline CIMT value but are not belong to 'high risk' category, according to the conventional risk factors.

Recruitment information / eligibility
Status Recruiting
Enrollment 1200
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- CIMT is not less than 0.9 mm

- without Clinical diagnosis of atherosclerotic disease

- without Diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin
atorvastatin 10mg/d
Behavioral:
• Aggressive lifestyle intervention
aggressive lifestyle intervention

Locations
Country Name City State
China Peking University First Hospital Beijing Beijing

Sponsors (2)
Lead Sponsor Collaborator
Ministry of Science and Technology of the People´s Republic of China Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The progress of CIMT 2 years No
Secondary The progress of ABI 2 years No
Secondary The progress of PWV 2 years No
Secondary Occurrence of atherosclerotic disease 2 years Yes
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