UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005563 |
|---|---|
| Receipt number | R000006590 |
| Scientific Title | Effect of statin with ezetimibe versus statin alone on progression of coronary atherosclerotic plaque: Evaluate by Intravasclular ultrasound Virtual Histology and Optical Coherence Tomography |
| Date of disclosure of the study information | 2011/05/07 |
| Last modified on | 2011/05/06 18:39:07 |
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Basic information
Public title
Effect of statin with ezetimibe versus statin alone on progression of coronary atherosclerotic plaque: Evaluate by Intravasclular ultrasound Virtual Histology and Optical Coherence Tomography
Acronym
ZEST registry
Scientific Title
Effect of statin with ezetimibe versus statin alone on progression of coronary atherosclerotic plaque: Evaluate by Intravasclular ultrasound Virtual Histology and Optical Coherence Tomography
Scientific Title:Acronym
ZEST registry
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of statin with ezetimibe versus statin alone
on progression of coronary atherosclerotic plaque using by Intravasclular ultrasound Virtual Histology and optical coherence tomography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OCT and VH IVUS findings at one year.
1. Thickness of fibrous cap in OCT
2. %necrotic core volume in VH
3. the incidence of thin-cap fibroatheroma in OCT and VH findings
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
One year
Fluvastatin (30mg) and Ezetimibe (10mg)
Interventions/Control_2
One year
Fluvastatin (30mg) alone
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Stable angina pectoris
2) All patients have 1 or 2-vessel diseases and were good candidates for percutaneous coronary intervention.
3) Target vessel for VH IVUS and OCT interrogation must not have undergone angioplasty or have more than 50% luminal narrowing throughout a target segment with a minimum length of 30mm
4) Target vessel for VH IVUS and OCT interrogation had mild-to-moderate vessel tortuosity and calcification
5) Left ventricular ejection fraction >30%
Key exclusion criteria
1) Unstable angina or myocardial infarction within the previous 4 weeks
2) Significant stenotic lesions in all coronary vessels
3) Target vessel for VH IVUS and OCT interrogation had lesions with angiographically detected thrombus
4) Contra-indications to IVUS and OCT examination
5) Other concomitant diseases or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis,stroke, or transient ischemic neurological attacks within the past year or hypersensitivity to heparin, aspirin, ticlopidine, or X-ray contrast media
6) Secondary causes of hyperlipid-emia or uncontrolled triglyceride level above 500 mg/dl
7) A positive pregnancy test.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenya Nasu |
Organization
Toyohashi Heart Center
Division name
Cardiovascular Medicine
Zip code
Address
21-1 Gobudori, Oyama-cho, Toyohashi, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Toyohashi Heart Ceter
Division name
Cardiovascular Medicine
Zip code
Address
21-1 Gobudori, Oyama-cho, Toyohashi, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Toyohashi Heart Ceter, Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Vascular Disease Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
豊橋ハートセンター
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 07 | 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
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | 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 | 05 | Month | 06 | Day |
Last modified on
| 2011 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006590
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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