UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026581 |
|---|---|
| Receipt number | 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 18:14:41 |
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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
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
katou_atsushi@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030478
