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| 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 |
| 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 |
| 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
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D+N: Experimental
Atorvastatin 10mg/d
|
Drug: Atorvastatin
atorvastatin 10mg/d
|
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P+A: Experimental
lifestyle intervention without Atorvastatin
|
Behavioral: Aggressive lifestyle intervention
aggressive lifestyle intervention
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|
D+A: Experimental
lifestyle intervention and Atorvastatin 10mg/d
|
Drug: Atorvastatin
atorvastatin 10mg/d
Behavioral: Aggressive lifestyle intervention
aggressive lifestyle intervention
|
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 |
Inclusion Criteria:
Contacts and Locations| Contact: Jianping Li | 86-10-66551122 ext 5262 |
| China | |
| Peking University First Hospital | Recruiting |
| Beijing, China, 100034 | |
| Contact lijianping@medmail.com.cn | |
| 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 History of Changes |
| Health Authority: | China: Ministry of Health |
|
Atherosclerosis Atorvastatin Therapeutic lifestyle change |
CIMT ABI PWV |
|
Antimetabolites Arterial Occlusive Diseases Atherosclerosis Antilipemic Agents Vascular Diseases |
Disease Progression Anticholesteremic Agents Arteriosclerosis Hydroxymethylglutaryl-CoA Reductase Inhibitors Atorvastatin |
|
Atherosclerosis Arterial Occlusive Diseases Antimetabolites Molecular Mechanisms of Pharmacological Action Antilipemic Agents Vascular Diseases Enzyme Inhibitors |
Arteriosclerosis Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Cardiovascular Diseases Atorvastatin |
