UMIN-CTR Clinical Trial

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
Email	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
Email	n.sakai@siren.ocn.ne.jp

Sponsor
Institute	Translational Research Informatics Canter
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005538