UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005501
Receipt number R000005306
Scientific Title Effect of Pitavastatin on restenosis with carotid artery stenting
Date of disclosure of the study information 2011/04/25
Last modified on 2019/07/30 10:00:20

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Basic information

Public title

Effect of Pitavastatin on restenosis with carotid artery stenting

Acronym

Effect of Pitavastatin on restenosis with carotid artery stenting

Scientific Title

Effect of Pitavastatin on restenosis with carotid artery stenting

Scientific Title:Acronym

Effect of Pitavastatin on restenosis with carotid artery stenting

Region

Japan


Condition

Condition

Patients scheduled carotid artery stenting

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of restenosis with carotid artery stenting by pitavastatin 1mg/day or pitavastatin 4mg/day

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The change of carotid artery plaque volume at carotid artery stent region using MDCT

Key secondary outcomes

1.Max IMT at carotid artery stent region and common carotid artery in ipsilateral side using echo
2.Max IMT at other side of carotid artery stent region using echo
3.The changes in TC, LDL-C, TG, HDL-C, non-HDL-C, LDL-C/HDL-C, RLP-C and MDA-LDL
4.The correlation between change in lipid profiles and change in max IMT at carotid artery stent region and common carotid artery in ipsilateral side
5.The correlation between change in lipid profiles and change in max IMT at other side of carotid artery stent region
6.Change in inflammation marker (CRP, SAA)
7.The correlation between Changes in inflammation marker and change in max IMT at carotid artery stent region and common carotid artery in ipsilateral side
8.The correlation between Changes in inflammation marker and change in max IMT at other side of carotid artery stent region
9.The incidence rate of adverse event
10.The changes in laboratory values


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pitavastatin 4 mg daily

Interventions/Control_2

Pitavastatin 1 mg daily

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

1.Patients scheduled carotid artery stenting
2.Hypercholesterolemia patients Meeting one of following criteria
1)TC is 220 mg/dL or over
2)LDL-C is 140 mg/dL or over
3)LDL-C is 120 mg/dL or over or TC is 200 mg/dL or over and requiring cholesterol lowering drugs judged by attending physicians
4) Patients given written informed consent
3.Age (20<= <85 year-old)
4.Patients given written informed consent

Key exclusion criteria

1.Malignant tumor in active phase
2.Patients who meet contraindication of LIVALO tablet below
1)Patients who have
hypersensitivity to LIVALO tablet
2)Patients who have severe liver dysfunction or biliary atresia
3)Patients who are being treated with cyclosporine
4)Pregnant women, women suspected of being pregnant, or lactating women
3.Patients with hypersensitive to contrast media
4.Patients with liver dysfunction [ALT(GPT) 100 IU/L <=]
5.Patients undergoing dialysis
6.Patients with familial
hypercholesterolemia
7.Patients who are ineligible in the opinion of the investigator

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kurisu K

Organization

Hiroshima University hospital

Division name

Neurosurgery

Zip code


Address

1-2-3 Kasumi Minamiku Hiroshima, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kiura Y

Organization

Hiroshima University hospital

Division name

Neurosurgery

Zip code


Address

1-2-3 Kasumi Minamiku Hiroshima, Japan

TEL

082-257-5555

Homepage URL


Email



Sponsor or person

Institute

Hiroshima University hospital

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


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 04 Month 25 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

Terminated

Date of protocol fixation

2011 Year 03 Month 09 Day

Date of IRB

2011 Year 04 Month 15 Day

Anticipated trial start date

2011 Year 05 Month 01 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 04 Month 25 Day

Last modified on

2019 Year 07 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005306


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name