UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004229
Receipt No. R000005084
Scientific Title Cilostazol SPECT Study
Date of disclosure of the study information 2010/11/01
Last modified on 2012/10/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.