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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004113
Receipt No. R000004946
Scientific Title Effect of Pitavastatin on preventing ischemic complications with carotid artery stenting (EPOCH-CAS)
Date of disclosure of the study information 2010/08/27
Last modified on 2014/03/03

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Basic information
Public title Effect of Pitavastatin on preventing ischemic complications with carotid artery stenting (EPOCH-CAS)
Acronym Effect of Pitavastatin on preventing ischemic complications with carotid artery stenting (EPOCH-CAS)
Scientific Title Effect of Pitavastatin on preventing ischemic complications with carotid artery stenting (EPOCH-CAS)
Scientific Title:Acronym Effect of Pitavastatin on preventing ischemic complications with carotid artery stenting (EPOCH-CAS)
Region
Japan

Condition
Condition Patients with carotid artery stenosis scheduled to undergo carotid artery stenting
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate preventing effect of Pitavastatin on perioperative ischemic complications with carotid artery stenting
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of distal embolism using MRI DWI
Key secondary outcomes 1) The composition and volume change of carotid artery plaque using MRI plaque imaging
2) The property change of carotid artery plaque using B-mode echo (GSM)
3) The incidence of ischemic stroke on the ipsilateral side of the carotid artery stenting in 4 weeks after CAS
4) The change of the serum lipid marker (total cholesterol, HDL cholesterol, triglycerides and LDL cholesterol)
5) The change of serum high sensitivity CRP
6) Cardiovascular events and mortality

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who have carotid artery stenosis and are scheduled to undergo carotid artery stenting more than 4 weeks after enrollment
1. Patients with 50% >= symptomatic stenosis or 80% >= asymptomatic carotid stenosis using the NASCET criterion
2. Patients at high risk for CEA
3. Patients requiring revascularization using CAS
2) Patients with 20 years old or older at the time of provision of consent
3) Patients providing written informed consent for participation in this clinical trial on their own volition after receiving a thorough explanation about the study
Key exclusion criteria 1) Patients with a history of hypersensitivity to any of the components of LIVALO tablet
2) Patients taking cyclosporin
3) Pregnant and possibly pregnant women, breast feeding women
4) Patients taking statins
5) Patients with liver dysfunction (AST or ALT &#8805; 100IU)&#61481; or biliary obstruction
6) Patients with severe renal dysfunction
7) Patients with contraindications for MRI
8) Patients who are judged by the principal or other investigator to be ineligible for enrollment in the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Waro Taki
Organization Mie university school of medicine
Division name Department of neurosurgery
Zip code
Address 2-174, Edobashi, Tsu city, Mie 514-8507, Japan
TEL 059-232-1111
Email nousinke@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Toma
Organization Mie university school of medicine
Division name Department of neurosurgery
Zip code
Address 2-174, Edobashi, Tsu city, Mie 514-8507, Japan
TEL 059-232-1111
Homepage URL
Email ntoma@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie university school of medicine Department of neurosurgery
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
2010 Year 08 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2010 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2010 Year 08 Month 27 Day
Last modified on
2014 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004946

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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