UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000454
Receipt number R000000552
Scientific Title A study on preventive effect of cilostazol against deterioration of symptoms in acute stage of lacunar infarctions
Date of disclosure of the study information 2006/08/01
Last modified on 2014/10/08 17:03:35

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Basic information

Public title

A study on preventive effect of cilostazol against deterioration of symptoms in acute stage of lacunar infarctions

Acronym

A study on efficacy for cilostazol for acute stage of lacunar infarctions

Scientific Title

A study on preventive effect of cilostazol against deterioration of symptoms in acute stage of lacunar infarctions

Scientific Title:Acronym

A study on efficacy for cilostazol for acute stage of lacunar infarctions

Region

Japan


Condition

Condition

ischemic stroke

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether cilostazol prevent worsening of symptoms in acute stage of lacunar infarctions

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Activity of Daily Living of 14days after onset which is assessed by modified Rankin Scale and Barthel Index

Key secondary outcomes

NIHSS: 7 and 14days after the admission
JSS: 7 and 14days after the admission
JSS-M: 7 and 14days after the admission
Barthel Index: 7 and 14days after the admission


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

administered aspirin of 200mg orally for 14days

Interventions/Control_2

administered aspirin of 200mg and cilostazol of 200mg orally for 14days.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients admitted within 48hours from onset of lacunar infarction
modified Rankin Scale less than grade 4 on admission

Key exclusion criteria

patients with active bleeding or bleeding tendency
chronic heart falure
peptic ulcer
anemia
leukocytopenia
thrombocytopenia
liver dysfunction
renal dysfunction
neoplastic disorders
allergy to aspirin or cilostazol
asthma caused by aspirin
patients taking antiplatelet drugs, anticoagulants or NSAIDS

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuo Terayama

Organization

Iwate Medical University

Division name

Department of Neurology

Zip code


Address

19-1 Uchimaru, Morioka, Iwate, Japan

TEL

019-651-5111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yasuhiro Ishibashi

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

yasubasi@iwate-med.ac.jp


Sponsor or person

Institute

Department of Neurology,Iwate Medical University

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


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

2006 Year 08 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

Completed

Date of protocol fixation

2006 Year 05 Month 13 Day

Date of IRB


Anticipated trial start date

2006 Year 08 Month 01 Day

Last follow-up date

2008 Year 07 Month 01 Day

Date of closure to data entry

2008 Year 07 Month 01 Day

Date trial data considered complete

2008 Year 07 Month 01 Day

Date analysis concluded

2008 Year 11 Month 01 Day


Other

Other related information



Management information

Registered date

2006 Year 07 Month 25 Day

Last modified on

2014 Year 10 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000552


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name