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
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
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
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
