UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005633 |
|---|---|
| Receipt number | R000006651 |
| Scientific Title | A single center randomized comparative study to know the effects of preoperative administration of atorvastatin on the plaque stability |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2011/05/23 22:10:35 |
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Basic information
Public title
A single center randomized comparative study to know the effects of preoperative administration of atorvastatin on the plaque stability
Acronym
Atorvastatin Before Carotid Artery Revascularization Therapy (AB-CART)
Scientific Title
A single center randomized comparative study to know the effects of preoperative administration of atorvastatin on the plaque stability
Scientific Title:Acronym
Atorvastatin Before Carotid Artery Revascularization Therapy (AB-CART)
Region
| Japan |
Condition
Condition
carotid artery stenosis
Classification by specialty
| Vascular surgery | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the effect of preoperative administration of atorvastatin on the carotid artery plaque in the patient scheduled for revascularization therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Volumetric changes of total plaque, lipid component, intraplaque hemorrhage on 3.0 Tesla MRI for the 4 weeks before revascularization
Key secondary outcomes
1) Change of max intima-media thickness(IMT) and peak systolic velocity(PSV) on carotid duplex scan for 4 weeks before revascularization
2) Number and volume of new high intensity spots on the DW-MRI within 3 days after revascularization
3) Serum lipid change (Total cholesterol, HDL-C, triglyceride and LDL-C)
4) Incidence of major cardiovascular events (non-fatal myocardial infarction, stroke, cardiovascular death and revascularization) for the 12 weeks after revascularization
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Atorvastatin 20mg/day for 4 weeks before revascularization
Interventions/Control_2
Medical treatment without atorvastatin for 4 weeks before revascularization
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria
1) Patient whose age is between 20 and 80 years
2) LDL-cholesterol < 160mg/dL
3) 50% or more stenosis for the symptomatic patient or 80% or more stenosis for the asymptomatic patients who eligible for carotid revascularization
4) Patient who signed an informed consent form
Key exclusion criteria
Exclusion criteria
1) Patients who were administrated statins within a month
2) Patients who have liver dysfunction (ALT and/or AST > 100IU/L)
3) Patients who have kidney dysfunction (serum creatinine > 1.5 mg/dL)
4) Patients who have history of allergy to statins
5) Women who is wishing a baby, pregnant or nursing
6) Patients who are inappropriate to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Yoshimura |
Organization
Graduate School of Medicine, Gifu University
Division name
Department of Neurosurgery
Zip code
Address
1-1 Yanagido, Gifu city, Gifu, Japan
TEL
+81-58-230-6271
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Yoshimura |
Organization
Graduate School of Medicine, Gifu University
Division name
Department of Neurosurgery
Zip code
Address
1-1 Yanagido, Gifu city, Gifu, Japan
TEL
+81-58-230-6271
Homepage URL
s-yoshi@gifu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Gifu University
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
岐阜大学医学部附属病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 23 | Day |
Last modified on
| 2011 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006651
