UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002674 |
|---|---|
| Receipt number | 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 16:21:46 |
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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
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
fyamane@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university international medical center
Department of Endovascular Neurosurgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003249
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