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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002674
Receipt No. R000003249
Scientific Title A pilot study on the safety and efficacy of an antithrombotic therapy during carotid artery stenting (CAS).
Date of disclosure of the study information 2010/02/01
Last modified on 2014/10/16

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Basic information
Public title A pilot study on the safety and efficacy of an antithrombotic therapy during carotid artery stenting (CAS).
Acronym SAITAMA-CAS:A pilot study on the safety and efficacy of an anti-thrombotic treatment in accordance with a CAS
Scientific Title A pilot study on the safety and efficacy of an antithrombotic therapy during carotid artery stenting (CAS).
Scientific Title:Acronym SAITAMA-CAS:A pilot study on the safety and efficacy of an anti-thrombotic treatment in accordance with a CAS
Region
Japan

Condition
Condition Those patients who have stenosis of more than 50% of the common carotid artery or internal carotid artery (diagnosed by ultrasonography or angiography), with neurological symptoms (transient cerebral ischemic stroke or cerebral stroke), or who have stenosis of more than 80% of the common carotid artery or internal carotid artery (diagnosed by ultrasonography or angiography) even if there are no neurological symptoms.
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of cilostazol as an antithrombotic therapy during CAS.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1Cumulative incidence of death, stroke, or myocardial infarction within 30 days after CAS.
2Cumulative incidence of death or ipsilateral stroke between 31 days and 1 year after CAS.
Key secondary outcomes 1Cumulative number of target-vessel revascularization at 1 year after CAS.
2Cumulative number of restenosis at 1 year after CAS. Restenosis is defined as 50% or more stenosis diagnosed by angiography when cerebral infarction is suspected.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients are to be administered concomitantly with aspirin 100 mg once a day and cilostazol 100 mg or 200 mg twice a day from at least 3 days before CAS. The combination therapy is to be continued for 3 months. After that (Month 4 and thereafter), patients are to be administered only with cilostazol twice a day.
When a staged stenting is to be carried out, patients are to be administered concomitantly with aspirin and cilostazol from at least 3 days before predilation. After postdilation, the concomitant therapy is to be continued for 3 months. After that, patients are to be administered only with cilostazol for 9 months.
Patients are to be evaluated for the endpoints (see above) before and during CAS, and 1 and 12 months after CAS.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Those patients for whom surgical treatment (carotid endarterectomy [CEA]) is difficult, and whose target vessel diameter is between 5 to 9 mm, and who meet either of the following criteria:
Having atheromatous stenosis of more than 50% of the common carotid artery or internal carotid artery that had been diagnosed by ultrasonography or angiography, with neurological symptoms (transient cerebral ischemic stroke or cerebral stroke).
Having atheromatous stenosis of more than 80% of the common carotid artery or internal carotid artery that had been diagnosed by ultrasonography or angiography, even if there are no neurological symptoms.
2 Those patients who can be administered concomitantly with aspirin and cilostazol from at least 3 days before CAS.
Key exclusion criteria 1Ischemic stroke within previous 48 hr
2Presence of intraluminal thrombus
3Total occlusion of target vessel
4Intracranial aneurysm > 9 mm in diameter
5Need for more than two stents
6History of bleeding disorder
7Percutaneous or surgical intervention planned within next 30 days
8Life expectancy < 1 year
9Ostial lesion of common carotid artery
10Ostial lesion of brachiocephalic artery
11Contraindication of Pletaal
12Contraindication of Aspirin
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoichiro Ishihara
Organization Saitama medical university international medical center
Division name Department of Endovascular Neurosurgery
Zip code
Address 1397-1 yamane Hidaka City Saitama
TEL 042-984-4531
Email shopar72@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumitaka Yamane
Organization Saitama medical university international medical center
Division name Department of Endovascular Neurosurgery
Zip code
Address 1397-1 yamane Hidaka City Saitama
TEL 042-984-4531
Homepage URL
Email fyamane@saitama-med.ac.jp

Sponsor
Institute Saitama medical university international medical center
Department of Endovascular Neurosurgery
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization none

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1 None
Study ID_2
Org. issuing International ID_2 None
IND to MHLW なし

Institutions
Institutions 埼玉医科大学国際医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 01 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
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 Terminated
Date of protocol fixation
2009 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 02 Month 01 Day
Date of closure to data entry
2012 Year 05 Month 01 Day
Date trial data considered complete
2012 Year 09 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 27 Day
Last modified on
2014 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003249

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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