UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004113 |
|---|---|
| Receipt number | 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 20:45:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 ≥ 100IU) 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
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
ntoma@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie university school of medicine Department of neurosurgery
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004946
