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

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

Status: Unknown

Conditions: Atherosclerosis

Treatments: Behavioral: Aggressive lifestyle intervention; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00723320

2006BAI01A02-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• CIMT is not less than 0.9 mm
• without Clinical diagnosis of atherosclerotic disease
• without Diabetes

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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1,200 participants in 4 patient groups

P+N

No Intervention group

Description:

placebo without lifestyle intervention

D+N

Experimental group

Description:

Atorvastatin 10mg/d

Treatment:

Drug: Atorvastatin

P+A

Experimental group

Description:

lifestyle intervention without Atorvastatin

Treatment:

Behavioral: Aggressive lifestyle intervention

D+A

Experimental group

Description:

lifestyle intervention and Atorvastatin 10mg/d

Treatment:

Behavioral: Aggressive lifestyle intervention

Drug: Atorvastatin