UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006971 |
|---|---|
| Receipt number | R000008218 |
| Scientific Title | Ezetimibe clinical investigation for the regression of intracoronary plaque evaluated by angioscopy and ultrasound |
| Date of disclosure of the study information | 2011/12/28 |
| Last modified on | 2015/06/10 11:40:06 |
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Basic information
Public title
Ezetimibe clinical investigation for the regression of intracoronary plaque evaluated by angioscopy and ultrasound
Acronym
eZetimibe clinical investigation for the regression of Intracoronary Plaque evaluated by ANGioscopy and Ultrasound(ZIPANGU study)
Scientific Title
Ezetimibe clinical investigation for the regression of intracoronary plaque evaluated by angioscopy and ultrasound
Scientific Title:Acronym
eZetimibe clinical investigation for the regression of Intracoronary Plaque evaluated by ANGioscopy and Ultrasound(ZIPANGU study)
Region
| Japan |
Condition
Condition
Coronary artery disease with dyslipidemia
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of lipid lowering therapies, atorvastatin + ezetimibe combination and atorvastatin monotherapy on coronary plaque characteristics and volume
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Yellow grade and volume of atherosclerotic plaques assessed by angioscopy and IVUS
Key secondary outcomes
1. Characteristics of atherosclerotic plaques assessed by IB-IVUS
2. Changes of lipid metabolism, gluco metabolism, bio markers (adiponectin, hs-CRP) cholesterol synthesis/absorption markers
3. Rate of Cardiovascular events
4. Rate of Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Conventional treatment
Atorvastatin 10-20mg/day
Interventions/Control_2
Additional treatment
Atorvastatin 10-20mg/day + ezetimibe 10mg/day
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective PCI and have yellow plaques(grade 2-4) fulfilled following inclusion criteria
1)Taking statin or LDL-C>=100mg/dL
without statin
2)Age:20-80(as a general rule), men and
women
3)Written informed consent
Key exclusion criteria
1) Patients have hypersensitivity to test
medicines
2) triglyceride>=400mg/dL
3) Patients with severe liver/renal
disease(AST and/or ALT is as thrice as
standard value/ dialysis, serum
creatinine>2.0mg/dL and/or CK>500IU/L)
4) HbA1c>=8% (JDS, >=8.4% in NGSP) or
taking administration of insulin
5) Patients with ACS(AMI, unstable
angina) histories within 3 months
6) Patients with secondary hyperlipidemia
or drug induced hyperlipidemia
7) Patients diagnosed malignancy
8) Patients with familial
hypercholesterolemia
9) Pregnant,breast-feeding, becoming
pregnant
10) treatment with cyclosporine
11) inadequate to this study
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIRAYAMA, Atsushi |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
Address
173-8610 30-1,Oyaguchi kami-cho,Itabashi-ku,Tokyo JAPAN
TEL
03-3972-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nouvelle Place Inc.
Division name
ZIPANGU study office
Zip code
Address
113-0034 1-6-3,Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-3814-2033
Homepage URL
zipangu@n-place.co.jp
Sponsor or person
Institute
Japan Health Promotion Foundation
Institute
Department
Personal name
Funding Source
Organization
Japan Health Promotion Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
尼崎中央病院心臓血管センター循環器内科(兵庫県)
Amagasaki chuou hospital(Hyogo)
浮間中央病院循環器内科(東京都)
Ukima central hospital(Tokyo)
愛媛県立今治病院循環器内科(愛媛県)
Ehime prefectural Imabari hospital(Ehime)
愛媛大学大学院病態情報内科学(愛媛県)
Ehime university graduate school of medicine(Ehime)
大阪警察病院心臓センター(大阪府)
Osaka police hospital(Osaka)
敬愛病院循環器科(東京都)
Keiai hospital(Tokyo)
西条中央病院循環器科(愛媛県)
Saijo central hospital(Ehime)
済生会松山病院循環器科(愛媛県)
Saiseikai Matsuyama hospital(Ehime)
市立宇和島病院循環器科(愛媛県)
Uwajima city hospital(Ehime)
日本大学医学部附属板橋病院循環器内科(東京都)
Nihon University Itabashi hospital(Tokyo)
東大阪市立総合病院循環器内科(大阪府)
Higashi-Osaka city general hospital(Osaka)
広島市立広島市民病院循環器内科(広島県)
The Hiroshima municipal Hiroshima citizen hospital(Hiroshima)
兵庫県立姫路循環器病センター循環器内科(兵庫県)
Hyogo prefectural Himeji circulatory organ illness center(Hyogo)
筑波大学医学部附属病院(茨城県）
Tsukuba University Hospital
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 28 | Day |
Last modified on
| 2015 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008218
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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