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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001114
Receipt No. 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

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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
Email

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
Email kyamada@gifu-u.ac.jp

Sponsor
Institute Gifu University Graduate School of Medicine
Department of Neurosurgery
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001347

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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