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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002722
Receipt No. R000003300
Scientific Title The effects of ezetimibe and atorvastatin in acute coronary syndrome (ZEUS study)
Date of disclosure of the study information 2009/11/28
Last modified on 2010/01/12

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Basic information
Public title The effects of ezetimibe and atorvastatin in acute coronary syndrome (ZEUS study)
Acronym ZEUS Study
Scientific Title The effects of ezetimibe and atorvastatin in acute coronary syndrome (ZEUS study)
Scientific Title:Acronym ZEUS Study
Region
Japan

Condition
Condition Acute Coronary Syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 ZEUS study will evaluate the effect of coadministration of ezetimibe and atorvastatin in patients with ACS.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the percent change in coronary plaque volume
Key secondary outcomes 1) absolute change from baseline in coronary plaque volume, (2) absolute change from baseline in coronary plaque stabilization(3)absolute and percent change in serum lipid and apolipoproteins (4) percent change in cholesterol absorption and synthesis markers (5)Correlation oflipid parameters and percent change in coronary plaque volume/stabilization (6) percent change in inflammatory marker and white blood cell count, (7) absolute and percent change in the coronary plaque area at the site of PCI, (8) absolute and percent change in MLD and %stenosis at the site of PCI, (9) major adverse cardiovascular event (MACE: defined as cardiac death, Q or non-Q wave myocardial infarction or TVR), (10) death, (11) any adverse incidents including changes in laboratory values

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ezetimibe 10mg daily
Atorvastatin 10mg daily
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria The ethical committee of all participation center approved the protocol and all patients provided written informed consent.This study will be included men and women>=20 years of age with clinical diagnosis of acute coronary syndrome (ACS) who will meet IVUS criteria
Key exclusion criteria 1,Advanced liver dysfunction
2,Renal failure
3,LDL cholesterol Level<100mg/dl
4,Any other reason for exclusion
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daida hiroyuki
Organization Juntendo University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 3-1-3 Hougou, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsumi Miyauchi
Organization Juntendo University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address
TEL 03-3813-3111
Homepage URL
Email

Sponsor
Institute Department of Cardiovascular Medicine, Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine, Juntendo University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2009 Year 11 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 No longer recruiting
Date of protocol fixation
2008 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2010 Year 06 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
2009 Year 11 Month 06 Day
Last modified on
2010 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003300

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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