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

Primary Purpose

Atherosclerosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Atorvastatin
Aggressive lifestyle intervention
Sponsored by
Ministry of Science and Technology of the People´s Republic of China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis focused on measuring Atherosclerosis, Atorvastatin, Therapeutic lifestyle change, CIMT, ABI, PWV

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

P+N

D+N

P+A

D+A

Arm Description

placebo without lifestyle intervention

Atorvastatin 10mg/d

lifestyle intervention without Atorvastatin

lifestyle intervention and Atorvastatin 10mg/d

Outcomes

Primary Outcome Measures

The progress of CIMT

Secondary Outcome Measures

The progress of ABI
The progress of PWV
Occurrence of atherosclerotic disease

Full Information

First Posted
July 21, 2008
Last Updated
August 22, 2008
Sponsor
Ministry of Science and Technology of the People´s Republic of China
Collaborators
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00723320
Brief Title
Effect of Atorvastatin and Lifestyle Intervention on Progression of Pre-Clinical Atherosclerosis
Acronym
EALIPPCA
Official Title
Effect of Atorvastatin and Lifestyle Intervention on Progression of Carotid Intima-Media Thickness in Chinese People Without Manifest Atherosclerotic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ministry of Science and Technology of the People´s Republic of China
Collaborators
Peking University First Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
Atherosclerosis, Atorvastatin, Therapeutic lifestyle change, CIMT, ABI, PWV

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
P+N
Arm Type
No Intervention
Arm Description
placebo without lifestyle intervention
Arm Title
D+N
Arm Type
Experimental
Arm Description
Atorvastatin 10mg/d
Arm Title
P+A
Arm Type
Experimental
Arm Description
lifestyle intervention without Atorvastatin
Arm Title
D+A
Arm Type
Experimental
Arm Description
lifestyle intervention and Atorvastatin 10mg/d
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
atorvastatin 10mg/d
Intervention Type
Behavioral
Intervention Name(s)
Aggressive lifestyle intervention
Intervention Description
aggressive lifestyle intervention
Primary Outcome Measure Information:
Title
The progress of CIMT
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The progress of ABI
Time Frame
2 years
Title
The progress of PWV
Time Frame
2 years
Title
Occurrence of atherosclerotic disease
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CIMT is not less than 0.9 mm without Clinical diagnosis of atherosclerotic disease without Diabetes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianping Li
Phone
86-10-66551122
Ext
5262
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianping Li
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
lijianping@medmail.com.cn

12. IPD Sharing Statement

Learn more about this trial

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

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