AtherosclerosisEALIPPCANCT00723320
Effect of Atorvastatin and Lifestyle Intervention on Progression of Pre-Clinical Atherosclerosis
A study testing Atorvastatin and Aggressive lifestyle intervention in people with Atherosclerosis, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Atorvastatin and Aggressive lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- Feb 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CIMT is not less than 0.9 mm
- without Clinical diagnosis of atherosclerotic disease
- without Diabetes
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Jianping Li contact
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
lijianping@medmail.com.cn
About this study
Official title: Effect of Atorvastatin and Lifestyle Intervention on Progression of Carotid Intima-Media Thickness in Chinese People Without Manifest Atherosclerotic Disease
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.
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- Atorvastatin, Aggressive lifestyle intervention
- Keywords
- Atherosclerosis, Atorvastatin, Therapeutic lifestyle change, CIMT, ABI, PWV
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
atorvastatin 10mg/d
Aggressive lifestyle interventionBehavioural
aggressive lifestyle intervention
| Study group | Role | What they receive |
|---|---|---|
| P+N | No intervention | placebo without lifestyle intervention |
| D+N | Experimental | Atorvastatin 10mg/d Receives: Drug: Atorvastatin |
| P+A | Experimental | lifestyle intervention without Atorvastatin Receives: Behavioral: Aggressive lifestyle intervention |
| D+A | Experimental | lifestyle intervention and Atorvastatin 10mg/d Receives: Drug: Atorvastatin; Behavioral: Aggressive lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The progress of CIMT
Measured: 2 years
Secondary outcomes (3)
The progress of ABI
Measured: 2 years
The progress of PWV
Measured: 2 years
Occurrence of atherosclerotic disease
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Collaborators
- Peking University First Hospital
- Investigators
- Jianping Li, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723320
- Sponsor's protocol ID
- 2006BAI01A02-03
- Acronym
- EALIPPCA
- Status last verified
- Jul 2008
- First submitted
- 21 Jul 2008
- Last updated
- 25 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atorvastatin and Lifestyle Intervention on Progression of Carotid Intima-Media Thickness in Chinese People Without Manifest Atherosclerotic Disease
- ClinicalTrials.gov ID
- NCT00723320
- Acronym / sponsor ID
- EALIPPCA / 2006BAI01A02-03
- Conditions
- Atherosclerosis
- Keywords
- Atherosclerosis, Atorvastatin, Therapeutic lifestyle change, CIMT, ABI, PWV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Collaborators
- Peking University First Hospital
- Study start
- Feb 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 28 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| P+N | No intervention | –placebo without lifestyle intervention |
| D+N | Experimental | Drug: AtorvastatinAtorvastatin 10mg/d |
| P+A | Experimental | Behavioral: Aggressive lifestyle interventionlifestyle intervention without Atorvastatin |
| D+A | Experimental | Drug: Atorvastatin, Behavioral: Aggressive lifestyle interventionlifestyle intervention and Atorvastatin 10mg/d |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CIMT is not less than 0.9 mm
- without Clinical diagnosis of atherosclerotic disease
- without Diabetes
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatinatorvastatin 10mg/d | Drug | D+A, D+N |
| Aggressive lifestyle interventionaggressive lifestyle intervention | Behavioural | D+A, P+A |
Primary outcome
The progress of CIMT
Time frame: 2 years
3 secondary outcomes
The progress of ABI
Time frame: 2 years
The progress of PWV
Time frame: 2 years
Occurrence of atherosclerotic disease
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianping Li contact
Jianping Li principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin and Aggressive lifestyle intervention in people with Atherosclerosis, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianping Li (86-10-66551122 ext. 5262), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The progress of CIMT (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2008.