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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026581
Receipt No. R000030478
Scientific Title The study about the effects of cholesterol absorption inhibition on coronary artery plaque in patients treated with PCI
Date of disclosure of the study information 2017/04/01
Last modified on 2017/03/31

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Basic information
Public title The study about the effects of cholesterol absorption inhibition on coronary artery plaque in patients treated with PCI
Acronym The effects of ezetimibe on coronary plaque
Scientific Title The study about the effects of cholesterol absorption inhibition on coronary artery plaque in patients treated with PCI
Scientific Title:Acronym The effects of ezetimibe on coronary plaque
Region
Japan

Condition
Condition coronary artery diseases
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study of the effects of cholesterol absorption inhibitor with statin on coronary artery plaque compared with only statin therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes coronary artery plaque, 1 years after
Key secondary outcomes clinical events 3 years after
lipid profile 1 years after

Base
Study type Interventional

Study design
Basic design Factorial
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 No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ezetimibe 10mg/day for one year
Interventions/Control_2 doubling dose statin for one year
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
40 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients with stable coronary artery disease receiving PCI and IVUS study
Key exclusion criteria 1) prior taking ezetimibe, 2) recent acute coronary syndrome (< 1 year), 3) renal insufficiency (serum creatinine > 2.0 mg / dL), 4) hepatic dysfunction (serum AST or ALT > 3-folds of standard value), 5) cancer, 6) autoimmune diseases, 7) impossibility in decision making 8) consideration as inadequate to participating in the study by attending physician.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Katoh
Organization Kurum University Medical Center
Division name Cardiology
Zip code
Address 155-1 Kokubu-machi, Kurume, Fukuoka, Japan
TEL 0942-22-6111
Email katou_atsushi@kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Katoh
Organization Kurum University Medical Center
Division name Cardiology
Zip code
Address 155-1 Kokubu-machi, Kurume, Fukuoka, Japan
TEL 0942-22-6111
Homepage URL
Email katou_atsushi@kurume-u.ac.jp

Sponsor
Institute Kurume University Medical Center
Institute
Department

Funding Source
Organization Kurume University
Organization
Division
Category of Funding Organization Other
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 久留米大学医療センター(福岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 04 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 Completed
Date of protocol fixation
2012 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 10 Day
Last follow-up date
2014 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 16 Day
Last modified on
2017 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030478

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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