UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004229 |
|---|---|
| Receipt number | R000005084 |
| Scientific Title | Cilostazol SPECT Study |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2012/10/04 11:01:39 |
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Basic information
Public title
Cilostazol SPECT Study
Acronym
C-SPECT
Scientific Title
Cilostazol SPECT Study
Scientific Title:Acronym
C-SPECT
Region
| Japan |
Condition
Condition
Cerebral inferction
Classification by specialty
| Cardiology | Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of cerebral blood flows in a cerebral infarction patients using the dual-table ARG method on antiplatelet agents.
Basic objectives2
Others
Basic objectives -Others
The amount of cerebral blood flows at rest and cerebrovascular reserve capacities using the dual-table ARG method
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
The amount of cerebral blood flows at rest and cerebrovascular reserve capacities using the dual-table ARG method
Key secondary outcomes
1. cardiovascular events
(Stroke,MI,PAD etc.)
2.ADL score (m-RS, Barthel index)
3. Existence of the onset of pneumonia
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 considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aspirin treatment group;
Aspirin 81 to 100 mg QD
Duration of treatment; 1 year
Interventions/Control_2
Cilostazol treatment group;
Cilostazol 200mg BID
In addition, it fluctuates suitably according to age and conditions.
Duration of treatment; 1 year
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with modified Rankin scale 0,1,or 2.
Patients aged 80 and below years at time of consent.
CT, MRI imaging: Patients with the extensive cerebral infarction dominated by a single vessel, and with passed over time when the infarct area is enhanced with CT or MRI imaging.
Vascular imaging: Patients with occlusion or severe stenosis of IC or MCA(excluding target of CEA).
Patient with stable general status.
Inclusion criteria of cerebral blood flows at rest and cerebrovascular reserve capacities
A. Patients with 80% and more of CBF at rest, and 30% and less of cerebrovascular reserve. capacities
B. Patients with 80% and less of CBF at rest, and 10 to 30% of cerebrovascular reserve capacities.
Key exclusion criteria
Patients by whom bypass surgery, CEA, or intravascular treatments are planned
Patients with cerebral infarction caused by non-arteriosclerosis.
Patients with critical complications such as malignant neoplasm, hepatic cirrhosis, renal failure, respiratory failure.
Patients with myocardial infarction for less than six months.
Patients with 300 or more mg/dl of fasting plasma glucose levels, or insulin treatment.
Patients with 110 or more mmHg of diastolic blood pressure.
Patients with artery to artery embolism.
Patients with cardiogenic cerebral embolism.
Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body)
Patients with ischemic heart failure
Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
Pregnant, possibly pregnant, or nursing women
Patients who are otherwise judged inappropriate for inclusion in the study by the investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jyoji Nakagawara |
Organization
Nakamura Memorial Hospital
Division name
Department of Neurosurgery
Zip code
Address
Minami 1, Nishi 14, Chuo-ku, Sapporo, Hokkaido 060-8570, Japan
TEL
011-231-8555
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Kamiyama |
Organization
Nakamura Memorial Hospital
Division name
Department of Neurosurgery
Zip code
Address
Minami 1, Nishi 14, Chuo-ku, Sapporo, Hokkaido 060-8570, Japan
TEL
011-231-8555
Homepage URL
neurosur@med.nmh.or.jp
Sponsor or person
Institute
Nakamura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Associations for Establishment of Evidence in Interventions
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
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
中村記念病院(北海道)、長岡中央綜合病院(新潟県)、国立病院機構九州医療センター(福岡県)、新潟県立新発田病院(新潟県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | 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 | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 17 | Day |
Last modified on
| 2012 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005084
