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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005501
Receipt No. 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

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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
Institute Hiroshima University hospital
Institute
Department

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
URL(English) https://upload.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


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