UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006593 |
|---|---|
| Receipt number | R000007801 |
| Scientific Title | Early statin treatment in patients with acute coronary syndrome: The best intensive LDL-cholesterol lowering therapy is sought by two different regimens during half a year treatment using Volumetric Intravascular Ultrasound Analysis (ESTABLISH-2 study) |
| Date of disclosure of the study information | 2011/11/01 |
| Last modified on | 2012/09/20 16:22:34 |
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Basic information
Public title
Early statin treatment in patients with acute coronary syndrome:
The best intensive LDL-cholesterol lowering therapy is sought by two different regimens during half a year treatment using Volumetric Intravascular Ultrasound Analysis
(ESTABLISH-2 study)
Acronym
ESTABLISH-2 study
Scientific Title
Early statin treatment in patients with acute coronary syndrome:
The best intensive LDL-cholesterol lowering therapy is sought by two different regimens during half a year treatment using Volumetric Intravascular Ultrasound Analysis
(ESTABLISH-2 study)
Scientific Title:Acronym
ESTABLISH-2 study
Region
| Japan |
Condition
Condition
To asses the efficacy of two different regimens of intensive LDL-cholesterol lowering therapy with statin or statin and ezetimibe on the plaque volume and plaque morphology in patients with acute coronary syndrome during 6 months.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To asses the efficacy of two different regimens of intensive LDL-cholesterol lowering therapy with statin or statin and ezetimibe on the plaque volume and plaque morphology in patients with acute coronary syndrome during 6 months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The percent change in plaque and vessel volume in non-culprit lesion on IVUS analysis during 6 months after onset of ACS.
Key secondary outcomes
Correlation between the percent change in plaque volume and the biomarkers including LDL-cholesterol level.
Major adverse cardiovascular event
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
In high dose statin group, patients will be administered 4mg of pitavastatin once daily during 6 monts follow-up.
Interventions/Control_2
In low dose statin group, patients will be administered 1mg of pitavastatin and 10mg of Ezetimibe once daily during 6 monts follow-up.
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
Patients are eligible for inclusion if they have ACS with significant stenosis on initial coronary angiography and recieved PCI. ACS is define as high-risk unstable angina, non-ST elevated myocardial infarction (NSTEMI) or ST-elevated MI (STEMI). MI will be diagnosed by patient symptoms, ECG changes (ST segment changes or a new bundle branch block) and highly sensitive biochemical markers (the rise in serum creatine phosphokinase-MB and positivity for troponin T or human heart fatty acid binding protein (H-FABP)), as well as information gleaned from various imaging techniques
Key exclusion criteria
A case of failed PCI
diseased bypass graft
recommended CABG
cardiogenic shock
A case of administration of other lipid-lowering drugs (clofibrate, probucol, nicotinic acid, or other prohibited drug without ezetimibe).
Target sample size
126
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Daida |
Organization
Juntendo University School of Medicine
Division name
Cardiology
Zip code
Address
3-1-10, Hongo,Bunkyo-ku, Tokyo,
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Okazaki |
Organization
Juntendo University Nerima hospital
Division name
Cardiology
Zip code
Address
3-1-10, Taknodai, Nerima-ku, Tokyo,
TEL
03-5923-3111
Homepage URL
shinya@juntendo-nerima.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo University Shizuoka hospital
(registration of case)
Juntendo University hospital
(IVUS anlysis)
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
順天堂大学 (東京都)/Juntendo University (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 01 | 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
| 2009 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 22 | Day |
Last modified on
| 2012 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007801
