UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006060
Receipt number R000007172
Scientific Title A multicenter randomized comparative study to know the effects of atorvastatin on the plaque stability before carotid artery stenting
Date of disclosure of the study information 2011/09/01
Last modified on 2014/09/03 20:33:11

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Basic information

Public title

A multicenter randomized comparative study to know the effects of atorvastatin on the plaque stability before carotid artery stenting

Acronym

Atorvastatin Before Carotid Artery Stenting(AB-CAS) Trial

Scientific Title

A multicenter randomized comparative study to know the effects of atorvastatin on the plaque stability before carotid artery stenting

Scientific Title:Acronym

Atorvastatin Before Carotid Artery Stenting(AB-CAS) Trial

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 stability and postoperative cerebral embolism after carotid artery stenting in patient with high-grade stenosis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Number of newly appeared high intensity spots on the diffusion weighted MRI(DW-MRI) within 3 days after CAS

Key secondary outcomes

1)Plaque quality change on MRI plaque imaging during operation waiting period
2)Changes of maximum intima-media complex thickness(IMT) and peak systolic velocity(PSV) on carotid duplex scan during operation waiting period
3)Volume of new high intensity spots on the DW-MRI performed 1-3 days after CAS
4)Serum lipid change(Total cholesterol,HDL-C,triglyceride and LDL-C)
5)Incidence of major cardiovascular events(non-fatal myocardial infarction,stroke,cardiovascular death and revascularization) until 12 weeks after CAS


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 carotid artery stenting and 12 weeks after carotid artery stenting

Interventions/Control_2

Medical treatment without atorvastatin for 4 weeks before carotid artery stenting and 12 weeks after carotid artery stenting

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)The patients with symptomatic stenosis (>=50%) or asymptomatic stenosis (>=80%) who is eligible for carotid artery stenting
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

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Yoshimura

Organization

Hyogo College of Medicine

Division name

Department of Neurosurgery

Zip code


Address

1-1 Mukogawa, Nishinomiya, Hyogo, Japan

TEL

+81-798-45-6455

Email

s-yoshi@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Yoshimura

Organization

Hyogo College of Medicine

Division name

Department of Neurosurgery

Zip code


Address

1-1 Mukogawa, Nishinomiya, Hyogo, Japan

TEL

+81-798-45-6455

Homepage URL


Email

s-yoshi@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine

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

Ichinomiya Nishi Hospital
Ube Kosan Central Hospital
Hyogo Medical University
Hiroshima University

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

2011 Year 09 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 08 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 Day

Last follow-up date

2015 Year 10 Month 31 Day

Date of closure to data entry

2015 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 07 Month 28 Day

Last modified on

2014 Year 09 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007172


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name