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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723320
First Posted: July 28, 2008
Last Update Posted: August 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Peking University First Hospital
Information provided by:
Ministry of Science and Technology of the People´s Republic of China
  Purpose
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 Intervention
Atherosclerosis Drug: Atorvastatin Behavioral: Aggressive lifestyle intervention

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ministry of Science and Technology of the People´s Republic of China:

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

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

Estimated Enrollment: 1200
Study Start Date: February 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
  Contacts and Locations
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
  More Information

Responsible Party: Yong Huo, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT00723320     History of Changes
Other Study ID Numbers: 2006BAI01A02-03
First Submitted: July 21, 2008
First Posted: July 28, 2008
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