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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006593
Receipt No. 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

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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
Email

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
Email shinya@juntendo-nerima.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007801

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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