Coronary Artery DiseasePhase 4AEPPNCT01086020
Atorvastatin Plus Ezetimibe on Coronary Plaque Progression
A Phase 4 study testing atorvastatin and atorvastatin plus ezetimibe in people with Coronary Artery Disease, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Atherosclerosis is a progressive disease. Lipid lowering therapy was the standard treatment for patients with coronary artery disease. Studies indicated that coronary artery plaque progression had positive relationship with the plasma cholesterol level, and could be halted or reversed by intensive statin therapy (such… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- atorvastatin and atorvastatin plus ezetimibe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Dec 2012
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to receive the coronary angiography and potential PCI therapy
Who cannot join
- Patients was treated by statins before randomization
- Patient with ≤ 20% and ≥ 70% coronary narrowing and target lesion
- ST elevation myocardial infarction less than 7 days
- Without informed consent
- Abnormal liver function before randomization, (AST, ALT ≥ULN)
- Active hepatitis or muscular disease
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- Impaired renal function with serum creatinine level > 3mg/dl
- Impaired left ventricular function with LVEF > 30%
- Participate in other studies
Trial locations and contacts
1 site in 1 country.
xin Chen, MD contact
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital,
Shanghai, Shanghai Municipality, 200025
Ruiyan Zhang, MD, 862164370045 ext. 665215, zhangruiyan@263.net
Xin Chen, MD, 862164370045 ext. 665380, rjchenxin@yahoo.com.cn
About this study
Official title: Same Lipid Lowering by Atorvastatin Versus Atorvastatin Plus Ezetimibe on Coronary Plaque Progression
Atherosclerosis is a progressive disease. Lipid lowering therapy was the standard treatment for patients with coronary artery disease. Studies indicated that coronary artery plaque progression had positive relationship with the plasma cholesterol level, and could be halted or reversed by intensive statin therapy (such as 20-40 mg/d atorvastatin). Ezetimibe plus statin could further lowered blood cholesterol level. Here the investigators hypothesize that same cholesterol lowering level by routing dose of atorvastatin or lower dose of atorvastatin plus ezetimibe could achieve the same effect on coronary artery plaque cessation or regression.
- Conditions
- Coronary Artery Disease
- Being tested
- atorvastatin, atorvastatin plus ezetimibe
- Keywords
- IVUS, coronary plaque, regression
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
Also called Lipitor
Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 10mg/d for two years
atorvastatin plus ezetimibeDrug
Also called Lipitor and ezetrol
Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d for two years
| Study group | Role | What they receive |
|---|---|---|
| atorvastatin | Active comparator | patients will be treated with atorvastatin 10mg/d after randomization, and continued for two years Receives: Drug: atorvastatin |
| atorvastatin and ezetimibe | Experimental | patients will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d after randomization, and continued for two years Receives: Drug: atorvastatin plus ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of coronary artery plaque volume
The primary endpoint was the change of coronary artery plaque volume measured by intravascular ultrasound (IVUS) at one year after randomization.
Measured: 1 year
Secondary outcomes (1)
composite of adverse cardiac events
The secondary endpoint was the composite of adverse cardiac events (MACE), including cardiac death, non-fatal infarction and target vessel revascularization at two years after randomization.
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 posted12 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Weifeng Shen, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086020
- Sponsor's protocol ID
- RJH20100101
- Acronym
- AEPP
- Status last verified
- Dec 2009
- First submitted
- 11 Mar 2010
- Last updated
- 4 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same Lipid Lowering by Atorvastatin Versus Atorvastatin Plus Ezetimibe on Coronary Plaque Progression
- ClinicalTrials.gov ID
- NCT01086020
- Acronym / sponsor ID
- AEPP / RJH20100101
- Conditions
- Coronary Artery Disease
- Keywords
- IVUS, coronary plaque, regression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 12 Mar 2010 (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.
Atherosclerosis is a progressive disease. Lipid lowering therapy was the standard treatment for patients with coronary artery disease. Studies indicated that coronary artery plaque progression had positive relationship with the plasma cholesterol level, and could be halted or reversed by intensive statin therapy (such as 20-40 mg/d atorvastatin). Ezetimibe plus statin could further lowered blood cholesterol level. Here the investigators hypothesize that same cholesterol lowering level by routing dose of atorvastatin or lower dose of atorvastatin plus ezetimibe could achieve the same effect on coronary artery plaque cessation or regression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atorvastatin | Active comparator | Drug: atorvastatinpatients will be treated with atorvastatin 10mg/d after randomization, and continued for two years |
| atorvastatin and ezetimibe | Experimental | Drug: atorvastatin plus ezetimibepatients will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d after randomization, and continued for two years |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Willing to receive the coronary angiography and potential PCI therapy
Key exclusion criteria (9 listed)
- Patients was treated by statins before randomization
- Patient with ≤ 20% and ≥ 70% coronary narrowing and target lesion
- ST elevation myocardial infarction less than 7 days
- Without informed consent
- Abnormal liver function before randomization, (AST, ALT ≥ULN)
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 |
|---|---|---|
| atorvastatinAlso: LipitorPatients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 10mg/d for two years | Drug | atorvastatin |
| atorvastatin plus ezetimibeAlso: Lipitor and ezetrolPatients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d for two years | Drug | atorvastatin and ezetimibe |
Primary outcome
change of coronary artery plaque volume
Time frame: 1 year
The primary endpoint was the change of coronary artery plaque volume measured by intravascular ultrasound (IVUS) at one year after randomization.
1 secondary outcome
composite of adverse cardiac events
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 4 Apr 2011.
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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.
xin Chen, MD contact
Weifeng Shen, MD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing atorvastatin and atorvastatin plus ezetimibe in people with Coronary Artery Disease, run by Shanghai Jiao Tong University School of Medicine 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 1 inclusion and 9 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 4 Apr 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ruiyan Zhang, MD (862164370045 ext. 665215, zhangruiyan@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of coronary artery plaque volume (time frame: 1 year). 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 4 Apr 2011.