UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001114 |
|---|---|
| Receipt number | R000001347 |
| Scientific Title | Effects of lipid lowering by atorvastatin on carotid atherosclerotic plaque (ACAP) study: a randomized trial for analysis of qualitative change in carotid atherosclerrotic plaque with IB echo and Black Blood MRI |
| Date of disclosure of the study information | 2008/05/01 |
| Last modified on | 2013/09/05 16:50:41 |
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Basic information
Public title
Effects of lipid lowering by atorvastatin on carotid atherosclerotic plaque (ACAP) study: a randomized trial for analysis of qualitative change in carotid atherosclerrotic plaque with IB echo and Black Blood MRI
Acronym
Atorvastatin on Carotid Atherosclerotic Plaque (ACAP) study
Scientific Title
Effects of lipid lowering by atorvastatin on carotid atherosclerotic plaque (ACAP) study: a randomized trial for analysis of qualitative change in carotid atherosclerrotic plaque with IB echo and Black Blood MRI
Scientific Title:Acronym
Atorvastatin on Carotid Atherosclerotic Plaque (ACAP) study
Region
| Japan |
Condition
Condition
Carotid artery stenosis
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of intensive lipid lowering with atorvastatin on carotid atherosclerrotic plaque characteristics using IB echo and Black Blood MRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The property change in carotid artery plaque after three and six months using IB echo and Black Blood MRI.
Key secondary outcomes
1) The change of the serum lipid metabolism in six months: Serum total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides
2) The change of the inflammatory marker in six months: serum high sensitivity CRP
3) Ischemic attack in the territory of the internal carotid artery on the ipsilateral side
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Atorvastatin
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
1) Patients with mild hypercholesterolemia; TC<240mg/dL
2) Patients with carotid stenosis of 30 to 60%
3) Patients naive to lipid-lowering medications at the study enrollement
Key exclusion criteria
1) Patients with a history of adverse effects or allergy to atorvastatin
2) Patients with a history of angina or miocardial infarction
3) Patients parformed carotid endartelectomy or carotid artery stenting before the entry of the study
4) Patients who are pregnant, possibly pregnant, or lactating
5) Patients judged inappropriate for this study by a physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Yoshimura |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
Yanagido 1-1, Gifu
TEL
058-230-6271
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyofumi Yamada |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
Yanagido 1-1, Gifu
TEL
058-230-6271
Homepage URL
kyamada@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Department of Neurosurgery
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
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
| 2008 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2006 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | 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
| 2008 | Year | 04 | Month | 08 | Day |
Last modified on
| 2013 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001347
