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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005538


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name