UMIN-CTR Clinical Trial

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
Last 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
Email

Public contact
1st 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
Email	neurosur@med.nmh.or.jp

Sponsor
Institute	Nakamura Memorial Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005084

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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