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

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ClinicalTrials.gov Identifier: NCT00723320
Recruitment Status : Unknown
Verified July 2008 by Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was:  Recruiting
First Posted : July 28, 2008
Last Update Posted : August 25, 2008
Sponsor:
Collaborator:
Peking University First Hospital
Information provided by:
Ministry of Science and Technology of the People´s Republic of China

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : February 2008
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. The progress of CIMT [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The progress of ABI [ Time Frame: 2 years ]
  2. The progress of PWV [ Time Frame: 2 years ]
  3. Occurrence of atherosclerotic disease [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723320


Contacts
Contact: Jianping Li 86-10-66551122 ext 5262

Locations
China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact       lijianping@medmail.com.cn   
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

Responsible Party: Yong Huo, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT00723320     History of Changes
Other Study ID Numbers: 2006BAI01A02-03
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: August 25, 2008
Last Verified: July 2008

Keywords provided by Ministry of Science and Technology of the People´s Republic of China:
Atherosclerosis
Atorvastatin
Therapeutic lifestyle change
CIMT
ABI
PWV

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors