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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000296
Receipt No. R000000376
Scientific Title Comparison of the effects between ozagrel Na combined with cilostazol and ozagrel Na alone for acute phase ischemic stroke in the territory of perforating arteries of the MCA; a randomized open trial.
Date of disclosure of the study information 2005/12/16
Last modified on 2006/01/13

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Basic information
Public title Comparison of the effects between ozagrel Na combined with cilostazol and ozagrel Na alone for acute phase ischemic stroke in the territory of perforating arteries of the MCA; a randomized open trial.
Acronym Efficacy of cilostazol in the treatment of acute phase ischemic stroke in the territory of perforating arteries of the MCA.
Scientific Title Comparison of the effects between ozagrel Na combined with cilostazol and ozagrel Na alone for acute phase ischemic stroke in the territory of perforating arteries of the MCA; a randomized open trial.
Scientific Title:Acronym Efficacy of cilostazol in the treatment of acute phase ischemic stroke in the territory of perforating arteries of the MCA.
Region
Japan

Condition
Condition Ischemic stroke
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess whether administration of cilostazol provides an clinical benefit of patients with acute phase ischemic stroke.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The frequency of patients with 'minimal or no neurological disability (defined as modified Rankin scale 0-2)' at 1 month into the treatment.
Key secondary outcomes (1)The frequency of neurological deterioration within 14 days into the treatment.
(2)NIHSS at 1 month into the treatment
(3)BI at 1 month into the treatment
(4)Vascular or other adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients will be randomly selected to receive combined therapy with ozagrel Na and cilostazol for 14 days. Cilostazol will be administered orally at a daily dose of 200mg.
Interventions/Control_2 Patients will also be randomly selected to receive treatment with ozagrel Na alone for 14 days.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Initial attack of stroke
(2)Beginning of treatment within 48 hours after the onset of symptoms
(3)Infarction in the territory of the perforating arteries of the MCA, which should be defined by MR DW image.
(4)Informed consent
Key exclusion criteria (1)Occlusive lesion of the internal carotid artery or the middle cerebral artery
(2)Hemorrhagic disorders
(3)Congestive heart failure
(4)Embolic stroke
(5)Severe liver and renal dysfunction
(6)Malignant disorders
(7)Taking cilostazol, ticlipidine
, aspirin or warfarin
(8)The patient participating in
other clinical trials
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Matsumoto
Organization Kohnan Hospital
Division name Department of Neuroendovascular
Zip code
Address 4-20-1 Nagamachi-minami Taihaku-ku Sendai Miyagi Japan
TEL 022-248-3585
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ryushi Kondoh
Organization Iwate medical university
Division name Department of Neurology
Zip code
Address 19-1 Uchimaru Morioka Iwate Japan
TEL 019-651-5111
Homepage URL
Email rkondoh@iwate-med.ac.jp

Sponsor
Institute Kohnan Hospital Department of Neuroendovascular Therapy
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
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

Other administrative information
Date of disclosure of the study information
2005 Year 12 Month 16 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
Date of protocol fixation
2005 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 12 Month 14 Day
Last modified on
2006 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000376

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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