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UMIN-CTR Clinical Trial |
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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 |
Basic information | ||
Public title | Cilostazol SPECT Study | |
Acronym | C-SPECT | |
Scientific Title | Cilostazol SPECT Study | |
Scientific Title:Acronym | C-SPECT | |
Region |
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Condition | ||||
Condition | Cerebral inferction | |||
Classification by specialty |
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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 |
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Interventions/Control_1 | Aspirin treatment group;
Aspirin 81 to 100 mg QD Duration of treatment; 1 year |
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Interventions/Control_2 | Cilostazol treatment group;
Cilostazol 200mg BID In addition, it fluctuates suitably according to age and conditions. Duration of treatment; 1 year |
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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 |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Terminated | ||||||
Date of protocol fixation |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |