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

NCT ID: NCT00723320

Last Updated: 2008-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atherosclerosis

Keywords

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Atherosclerosis Atorvastatin Therapeutic lifestyle change CIMT ABI PWV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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P+N

placebo without lifestyle intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

D+N

Atorvastatin 10mg/d

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

atorvastatin 10mg/d

P+A

lifestyle intervention without Atorvastatin

Group Type EXPERIMENTAL

Aggressive lifestyle intervention

Intervention Type BEHAVIORAL

aggressive lifestyle intervention

D+A

lifestyle intervention and Atorvastatin 10mg/d

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

atorvastatin 10mg/d

Aggressive lifestyle intervention

Intervention Type BEHAVIORAL

aggressive lifestyle intervention

Interventions

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Atorvastatin

atorvastatin 10mg/d

Intervention Type DRUG

Aggressive lifestyle intervention

aggressive lifestyle intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* CIMT is not less than 0.9 mm
* without Clinical diagnosis of atherosclerotic disease
* without Diabetes
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Peking University First Hospital

Principal Investigators

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Jianping Li

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianping Li

Role: CONTACT

Phone: 86-10-66551122

Facility Contacts

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Role: primary

Other Identifiers

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2006BAI01A02-03

Identifier Type: -

Identifier Source: org_study_id