UMIN-CTR Clinical Trial

Public title

Exploratory clinical study of qualitative and quantitative effect with pitavastatin on carotid artery plaque.

Acronym

TART study

Scientific Title

Exploratory clinical study of qualitative and quantitative effect with pitavastatin on carotid artery plaque.

Scientific Title:Acronym

TART study

Region

Japan

Condition

Hypercholesterolemia with carotid artery plaque

Classification by specialty

Medicine in general	Cardiology	Endocrinology and Metabolism
Neurology	Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the effect of pitavastatin on the carotid plaques in patients with hypercholesterolemia.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Qualitative and quantitative change of carotid artery plaque by carotid artery echo and MRI evaluation.

Key secondary outcomes

1)Change of serum lipids(TC,LDL-C,TG,HDL-C).
2)Incidence rate of event.
3)Change of hs-CRP and osteopontin.
4)Evaluation of carotid artery plaque by microbubble contrast material.
5)Evaluation of carotid artery plaque by contrast-enhanced CT.
6) Relationship of change of carotid artery plaque and serum lipids, blood marker.
7)Change of intracranial stenosis.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pitavastatin will be administered for 6 months at a dosage of 1~4 mg/day.

Interventions/Control_2

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1)The patient who observed the plaque in the carotid artery by MRI(Not less than 50% of the degree of stenosis).
2)The patient who is going not to perform CAS and CEA etc. but to perform
Follow up.
3)At the time of entry, pitavastatin is not taken.
4)Patients with hypercholesterolemia.
5)Patients aged 20 years or older at the time of giving consent.
6)Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial.

Key exclusion criteria

1)At the time of entry, pitavastatin is taken.
2)The patient who had enforced CAS in the past to the carotid artery plaque lesion which evaluates.
3)Patients who have hypersensitivity to LIVALO tablet.
4)Patients who are being treated with cyclosporine.
5)Patients who have liver dysfunction
The following patients considered that biliary obstruction or liver metabolism ability is falling(acute hepatitis, Acute aggravation of chronic hepatitis, hepatic cirrhosis, hepatoma, jaundice)
6)Pregnant women, women suspected of being pregnant, or lactating women
7)Patients who have renal dysfunction, or undergoing dialysis.
8)Patients who are ineligible in the opinion of the investigator.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiaki Kumon

Organization

Ehime University

Division name

Neurosurgery

Zip code

Address

Shitsukawa, Toon-shi, Ehime

TEL

089-964-5338

Email

Name of contact person

1st name
Middle name
Last name	Yoshiaki Kumon

Organization

Ehime University

Division name

Neurosurgery

Zip code

Address

Shitsukawa, Toon-shi, Ehime

TEL

089-964-5338

Homepage URL

Email

ykumon@m.ehime-u.ac.jp

Institute

Ehime 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

Date of disclosure of the study information

2012

Year

06

Month

30

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

Open public recruiting

Date of protocol fixation

2012

Year

05

Month

28

Day

Date of IRB

Anticipated trial start date

2012

Year

06

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

2012

Year

06

Month

29

Day

Last modified on

2012

Year

06

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009781