UMIN-CTR Clinical Trial

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

carotid artery stenosis

Classification by specialty

Vascular surgery

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

Email

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

Email

s-yoshi@gifu-u.ac.jp

Institute

Graduate School of Medicine, Gifu University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

岐阜大学医学部附属病院（岐阜県）

Date of disclosure of the study information

2011

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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