The Effects of Ezetimibe on Coronary Plaque Volume in Patients With Acute Coronary Syndrome
Assessment of the Effects of Ezetimibe on Coronary Plaque Volume in Patients With Acute Coronary Syndrome
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of this study is to assess the effects of Ezetimibe on coronary plaque volume in patients with acute coronary syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 coronary-artery-disease
Started Oct 2010
Longer than P75 for phase_4 coronary-artery-disease
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
First Submitted
Initial submission to the registry
February 11, 2010
CompletedFirst Posted
Study publicly available on registry
February 12, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 22, 2010
October 1, 2010
5 years
February 11, 2010
October 21, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
the percent change in coronary plaque volume, the percent change in integrated backscatter signal obtained by integrated backscatter IVUS
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
9-11 months
Interventions
10mg daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yokohama City University Medical Center
Yokohama, Kanagawa, 231-0045, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kiyoshi Hibi
Yokohama City University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 11, 2010
First Posted
February 12, 2010
Study Start
October 1, 2010
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 22, 2010
Record last verified: 2010-10