UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005997
Receipt number R000007095
Scientific Title Study on the responsiveness of antiplatelet drugs in patients with cerebral infarction.
Date of disclosure of the study information 2011/07/20
Last modified on 2011/07/19 01:22:15

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Basic information

Public title

Study on the responsiveness of antiplatelet drugs in patients with cerebral infarction.

Acronym

Study on the responsiveness of antiplatelet drugs in patients with cerebral infarction.

Scientific Title

Study on the responsiveness of antiplatelet drugs in patients with cerebral infarction.

Scientific Title:Acronym

Study on the responsiveness of antiplatelet drugs in patients with cerebral infarction.

Region

Japan


Condition

Condition

Noncardioembolic ischemic stroke

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To examine the responsiveness of the antiplatelets by measuring the platelet aggregation ability in a cerebral infarction patient who needs the antiplatelet treatment using VerifyNow and to analyze genetic polymorphism related to platelet aggregation ability.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

stroke reccurence

Key secondary outcomes

Occurrence of cerebral hemorrhage, or subarachnoid hemorrhage


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

Noncardioembolic ischemic stroke

Key exclusion criteria

Do not obtain consent

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norihiro Suzuki

Organization

Keio University School of Medicine

Division name

Department of Neurology

Zip code


Address

35 Shinanomachi Shinjuku-ku Tokyo 160-8582 Japan

TEL

03-3353-1211

Email



Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Yamada

Organization

Keio University School of Medicine

Division name

Department of Neurology

Zip code


Address

35 Shinanomachi Shinjuku-ku Tokyo 160-8582 Japan

TEL

03-3353-1211

Homepage URL


Email

syamada-keio@umin.net


Sponsor or person

Institute

Keio University School of Medicine
Department of Neurology

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

Tokyo Saiseikai Central Hospital

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

慶應義塾大学病院(東京都)
東京都済生会中央病院(東京都)


Other administrative information

Date of disclosure of the study information

2011 Year 07 Month 20 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

Enrolling by invitation

Date of protocol fixation

2011 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective study


Management information

Registered date

2011 Year 07 Month 19 Day

Last modified on

2011 Year 07 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007095


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name