UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002722 |
|---|---|
| Receipt number | 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 16:03:01 |
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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
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
Sponsor or person
Institute
Department of Cardiovascular Medicine, Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003300
