UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003217 |
|---|---|
| Receipt number | R000001556 |
| Scientific Title | Association between atorvastatin and human carotid plaque stabilization |
| Date of disclosure of the study information | 2010/03/01 |
| Last modified on | 2010/02/20 19:26:30 |
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Basic information
Public title
Association between atorvastatin and human carotid plaque stabilization
Acronym
Atorvastatin and human carotid plaque
Scientific Title
Association between atorvastatin and human carotid plaque stabilization
Scientific Title:Acronym
Atorvastatin and human carotid plaque
Region
| Japan |
Condition
Condition
Carotid stenosis
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of atorvastatin in human carotid plaque stabilization.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The fraction of area with macrophage rich in carotid plaque
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
atorvastatin+diet
Interventions/Control_2
diet
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Moderate hypercholesterolemia
220mg/dL<total cholesterol<260mg/dL
Or
140mg/dL<LDL cholesterol<180mg/dL
CEA is planned one month or more.
Informed consent was needed.
Key exclusion criteria
Medicated by any statin with LDL cholesterol < 140 mg/dL
Secondary hypercholesterolemia
CEA has been performed ipsilateraly
Hemorrhagic stroke
Bleeding tendency
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Okada |
Organization
Tokyo Women's Medical University
Division name
neurosurgery
Zip code
Address
8-1, Kawada-chou, Shinjyuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Women's Medical University
Division name
Neurosurgery
Zip code
Address
TEL
0333538111
Homepage URL
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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
| 2010 | Year | 03 | 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
Date of protocol fixation
| 2008 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | 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
| 2010 | Year | 02 | Month | 20 | Day |
Last modified on
| 2010 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001556
