Effect of Atorvastatin and Lifestyle Intervention on Progression of Pre-Clinical Atherosclerosis (EALIPPCA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Ministry of Science and Technology of the People´s Republic of China
Collaborator:
Peking University First Hospital
Information provided by:
Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier:
NCT00723320
First received: July 21, 2008
Last updated: August 22, 2008
Last verified: July 2008
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, 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:
MedlinePlus related topics:
Atherosclerosis
Drug Information available for:
Atorvastatin calcium
U.S. FDA Resources
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 |
|---|---|
|
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| 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, 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
No publications provided
| Responsible Party: | Yong Huo, Peking University First Hospital |
| ClinicalTrials.gov Identifier: | NCT00723320 History of Changes |
| Other Study ID Numbers: | 2006BAI01A02-03 |
| Study First Received: | July 21, 2008 |
| Last Updated: | August 22, 2008 |
| 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 |
Additional relevant MeSH terms:
|
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013