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

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

This study is currently recruiting participants.

Verified by Ministry of Science and Technology of the People´s Republic of China, July 2008

Sponsors and Collaborators:	Ministry of Science and Technology of the People´s Republic of China Peking University First Hospital
Information provided by:	Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier:	NCT00723320

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

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Effect of Atorvastatin and Lifestyle Intervention on Progression of Carotid Intima-Media Thickness in Chinese People Without Manifest Atherosclerotic Disease

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The progress of ABI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The progress of PWV [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Occurrence of atherosclerotic disease [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723320

Contacts

Contact: Jianping Li

86-10-66551122 ext 5262

Locations

China
Peking University First Hospital	Recruiting
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:	Peking University First Hospital ( Yong Huo )
Study ID Numbers:	2006BAI01A02-03
Study First Received:	July 21, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00723320
Health Authority:	China: Ministry of Health

Keywords provided by Ministry of Science and Technology of the People´s Republic of China:

Atherosclerosis
Atorvastatin
Therapeutic lifestyle change

CIMT
ABI
PWV

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases

Disease Progression
Arteriosclerosis
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009