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

• Sponsor: Ministry of Science and Technology of the People´s Republic of China (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00723320
• Collaborator: Peking University First Hospital (Other)
• Enrollment: 1,200
• Location: 1
• Arms: 4
• Duration (Months): 34
• Patients Per Site Per Month: 35.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis	Drug: Atorvastatin; Behavioral: Aggressive lifestyle intervention	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1200 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effect of Atorvastatin and Lifestyle Intervention on Progression of Carotid Intima-Media Thickness in Chinese People Without Manifest Atherosclerotic Disease
• Study Start Date: Feb 1, 2008
• Anticipated Primary Completion Date: Dec 1, 2010
• Anticipated Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: P+N placebo without lifestyle intervention
Experimental: D+N Atorvastatin 10mg/d	Drug: Atorvastatin; atorvastatin 10mg/d
Experimental: P+A lifestyle intervention without Atorvastatin	Behavioral: Aggressive lifestyle intervention; aggressive lifestyle intervention
Experimental: D+A lifestyle intervention and Atorvastatin 10mg/d	Drug: Atorvastatin; atorvastatin 10mg/d; Behavioral: Aggressive lifestyle intervention; aggressive lifestyle intervention

Outcome Measures

Primary Outcome Measures

1. The progress of CIMT [2 years]

Secondary Outcome Measures

1. The progress of ABI [2 years]

2. The progress of PWV [2 years]

3. Occurrence of atherosclerotic disease [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• CIMT is not less than 0.9 mm

• without Clinical diagnosis of atherosclerotic disease

• without Diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University First Hospital	Beijing	Beijing	China	100034

Sponsors and Collaborators

• Ministry of Science and Technology of the People´s Republic of China
• Peking University First Hospital

Investigators

• Principal Investigator: Jianping Li, Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00723320
• Other Study ID Numbers: 2006BAI01A02-03
• First Posted: Jul 28, 2008
• Last Update Posted: Aug 25, 2008
• Last Verified: Jul 1, 2008

• Keywords provided by , ,: Atherosclerosis; Atorvastatin; Therapeutic lifestyle change; CIMT; ABI; PWV
• Additional relevant MeSH terms: Atherosclerosis; Atorvastatin

Study Results

No Results Posted as of Aug 25, 2008