Coronary Artery DiseasePhase 4NCT01068093
The Effects of Ezetimibe on Coronary Plaque Volume in Patients With Acute Coronary Syndrome
A Phase 4 study testing Ezetimibe in people with Coronary Artery Disease, run by Yokohama City University Medical Center at 1 site in Japan.
Trial summary
The purpose of this study is to assess the effects of Ezetimibe on coronary plaque volume in patients with acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ezetimibe
- How many people
- 120 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2010to Oct 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been diagnosed as acute coronary syndrome, and successful percutaneous coronary intervention (PCI) were performed with intravascular ultrasound (IVUS) guidance.
- Patients having coronary plaques (≧ 500 µm in thickness or % plaque of 20% or more at ≧ 5 mm distal or proximal to the previously treated area in the same branch of coronary artery.
Who cannot join
- Patients with bypass graft or in-stent restenosis at the site of PCI.
- Patients who received PCI in the past on the lesion where the evaluation of coronary plaque volume is planned.
- Patients who had plaques in a non-culprit site and might receive PCI during the treatment period.
- Patients receiving lipid-lowering drugs (statins, fibrates, probucol, nicotinic acid or cholesterol absorption inhibitors).
- Patients with familial hypercholesterolemia.
- Patients with cardiogenic shock.
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- Patients receiving cyclosporine.
- Patients with any allergy to Ezetimibe.
- Patients with hepatobiliary disorders.
- Pregnant women, women suspected of being pregnant, or lactating women.
- Patients with renal disorders or undergoing dialysis.
- Patients who are ineligible in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Yokohama City University Medical Center
Yokohama, Kanagawa, 231-0045
Kiyoshi Hibi, 81-45-261-5656 ext. 7205, hibikiyo@yokohama-cu.ac.jp
Kiyoshi Hibi
About this study
Official title: Assessment of the Effects of Ezetimibe on Coronary Plaque Volume in Patients With Acute Coronary Syndrome
The purpose of this study is to assess the effects of Ezetimibe on coronary plaque volume in patients with acute coronary syndrome.
Read the detailed description
Previous studies reported that administration of statins in patients with coronary artery disease resulted in significant reduction of low-density lipoprotein cholesterol(LDL-C) and regression of coronary plaque volume, and a decrease in the level of LDL-C through statin treatment positively correlates with a reduction in the volume of plaques. Administration of Ezetimibe in addition to statin has been shown to be more effective at reducing LDL-C levels compared with statin monotherapy. However, the effects of Ezetimib on coronary plaque volume remain unclear. In this study, the investigators assess the effect of Ezetimibe on coronary plaque volume and tissue composition in patients with acute coronary syndrome.
- Conditions
- Coronary Artery Disease
- Being tested
- Ezetimibe
- 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.
EzetimibeDrug
10mg daily
What is being measured
The primary outcome is the main question the study is designed to answer.
the percent change in coronary plaque volume, the percent change in integrated backscatter signal obtained by integrated backscatter IVUS
Measured: 9-11 months
Secondary outcomes (1)
absolute change from baseline in coronary plaque volume, absolute and percent changes in minimal lumen diameter and percent stenosis, absolute and percent changes in total cholesterol and low-density lipoprotein cholesterol
Measured: 9-11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (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
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yokohama City University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Kiyoshi Hibi, Principal investigator, Yokohama City University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068093
- Sponsor's protocol ID
- Y-ACS-E
- Status last verified
- Oct 2010
- First submitted
- 11 Feb 2010
- Last updated
- 22 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Ezetimibe on Coronary Plaque Volume in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01068093
- Acronym / sponsor ID
- Y-ACS-E
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yokohama City University Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 12 Feb 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.
The purpose of this study is to assess the effects of Ezetimibe on coronary plaque volume in patients with acute coronary syndrome.
Detailed description
Previous studies reported that administration of statins in patients with coronary artery disease resulted in significant reduction of low-density lipoprotein cholesterol(LDL-C) and regression of coronary plaque volume, and a decrease in the level of LDL-C through statin treatment positively correlates with a reduction in the volume of plaques. Administration of Ezetimibe in addition to statin has been shown to be more effective at reducing LDL-C levels compared with statin monotherapy. However, the effects of Ezetimib on coronary plaque volume remain unclear. In this study, the investigators assess the effect of Ezetimibe on coronary plaque volume and tissue composition in patients with acute coronary syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have been diagnosed as acute coronary syndrome, and successful percutaneous coronary intervention (PCI) were performed with intravascular ultrasound (IVUS) guidance.
- Patients having coronary plaques (≧ 500 µm in thickness or % plaque of 20% or more at ≧ 5 mm distal or proximal to the previously treated area in the same branch of coronary artery.
Key exclusion criteria (12 listed)
- Patients with bypass graft or in-stent restenosis at the site of PCI.
- Patients who received PCI in the past on the lesion where the evaluation of coronary plaque volume is planned.
- Patients who had plaques in a non-culprit site and might receive PCI during the treatment period.
- Patients receiving lipid-lowering drugs (statins, fibrates, probucol, nicotinic acid or cholesterol absorption inhibitors).
- Patients with familial hypercholesterolemia.
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 |
|---|---|---|
| Ezetimibe10mg daily | Drug | – |
Primary outcome
the percent change in coronary plaque volume, the percent change in integrated backscatter signal obtained by integrated backscatter IVUS
Time frame: 9-11 months
1 secondary outcome
absolute change from baseline in coronary plaque volume, absolute and percent changes in minimal lumen diameter and percent stenosis, absolute and percent changes in total cholesterol and low-density lipoprotein cholesterol
Time frame: 9-11 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2010.
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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.
Kiyoshi Hibi principal investigator
Yokohama City University Medical Center
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 Ezetimibe in people with Coronary Artery Disease, run by Yokohama City University Medical Center at 1 site in Japan.
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 2 inclusion and 12 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 22 Oct 2010. 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 Japan. 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 Kiyoshi Hibi (81-45-261-5656 ext. 7205, hibikiyo@yokohama-cu.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percent change in coronary plaque volume, the percent change in integrated backscatter signal obtained by integrated backscatter IVUS (time frame: 9-11 months). 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 22 Oct 2010.