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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005563
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Toyohashi Heart Ceter, Cardiovascular Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006590

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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