UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000296
Receipt number 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 18:52:59

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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 or person

Institute

Kohnan Hospital Department of Neuroendovascular Therapy

Institute

Department

Personal name



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

Value
https://center6.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