UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004705 |
|---|---|
| Receipt number | R000005538 |
| Scientific Title | Effect of cilostazol on in-stent restenosis after carotid artery stenting; Multi-center, prospective, randomized, open-label blind-endpoint trial |
| Date of disclosure of the study information | 2010/12/12 |
| Last modified on | 2019/10/08 17:00:24 |
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Basic information
Public title
Effect of cilostazol on in-stent restenosis after carotid artery stenting; Multi-center, prospective, randomized, open-label blind-endpoint trial
Acronym
Carotid Artery Stenting with Cilostazol Addition for Restenosis (CAS-CARE)
Scientific Title
Effect of cilostazol on in-stent restenosis after carotid artery stenting; Multi-center, prospective, randomized, open-label blind-endpoint trial
Scientific Title:Acronym
Carotid Artery Stenting with Cilostazol Addition for Restenosis (CAS-CARE)
Region
| Japan |
Condition
Condition
Carotid Artery Diseases
Classification by specialty
| Neurology | Radiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study was conducted to evaluate the inhibitory effect of cilostazol, compared to that of other antiplatelet drugs, on in-stent restenosis following carotid artery stenting (CAS) in patients scheduled to undergo CAS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence of in-stent restenosis within 2 yrs after Carotid Artery Stenting and time to occurrence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Continuous administration of cilostazol (unrestricted use of other antiplatelet agents and concomitant drugs)
Interventions/Control_2
Antiplatelet agent other than cilostazol (unrestricted use of concomitant drugs)
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
| 45 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
50% or more symptomatic carotid artery stenosis or 80% or more asymptomatic carotid artery stenosis
Scheduled for carotid artery stenting within 30 days of enrolment
Antiplatelet agents can be administered orally and possible for 2-years follow-up
Self-supported in daily activities (modified rankin Scale is 2 or less)
Patients who have given informed consent to participation in the study
Key exclusion criteria
Received endovascular interevention
Scheduled for bilateral carotid intervention
aortitis or cvasculitis
congessive heart failure
ischemic stroke within 48 hours
hemorrhagic stroke within 90 days
renal failure
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Sakai |
Organization
Kobe City Medical Center general Hospital
Division name
Neurosurgery
Zip code
650-0047
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL
078-302-4321
n.sakai@siren.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Sakai |
Organization
Kobe City Medical Center general Hospital
Division name
Neurosurgery
Zip code
650-0047
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL
078-302-4321
Homepage URL
n.sakai@siren.ocn.ne.jp
Sponsor or person
Institute
Translational Research Informatics Canter
Institute
Department
Personal name
Funding Source
Organization
Translational Research Informatics Canter
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe City Medical Center General Hospital
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
Tel
078-302-4321
rinken@kcho.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01261234
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
神戸市立医療センター中央市民病院（兵庫県）、広南病院（宮城県）、虎の門病院（東京都）、名古屋大学（愛知県）、岐阜大学（岐阜県）、大阪大学（大阪府）、岡山大学（岡山県）、他
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 12 | 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
707
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
not yet repoted
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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 11 | Day |
Last modified on
| 2019 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005538
