Effect of Atorvastatin and Lifestyle Intervention on Progression of Pre-Clinical Atherosclerosis
EALIPPCA
1 other identifier
interventional
1,200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 21, 2008
CompletedFirst Posted
Study publicly available on registry
July 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 25, 2008
July 1, 2008
2.8 years
July 21, 2008
August 22, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The progress of CIMT
2 years
Secondary Outcomes (3)
The progress of ABI
2 years
The progress of PWV
2 years
Occurrence of atherosclerotic disease
2 years
Study Arms (4)
P+N
NO INTERVENTIONplacebo without lifestyle intervention
D+N
EXPERIMENTALAtorvastatin 10mg/d
P+A
EXPERIMENTALlifestyle intervention without Atorvastatin
D+A
EXPERIMENTALlifestyle intervention and Atorvastatin 10mg/d
Interventions
Eligibility Criteria
You may qualify if:
- CIMT is not less than 0.9 mm
- without Clinical diagnosis of atherosclerotic disease
- without Diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianping Li
Peking University First Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
July 21, 2008
First Posted
July 28, 2008
Study Start
February 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
August 25, 2008
Record last verified: 2008-07