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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006870
Receipt No. R000008119
Scientific Title Evauation of usefulness of clopidogrel bisulfate against ischemic cerebrovascular disorders
Date of disclosure of the study information 2011/12/12
Last modified on 2011/12/11

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Basic information
Public title Evauation of usefulness of clopidogrel bisulfate against ischemic cerebrovascular disorders
Acronym DuaLS study
Scientific Title Evauation of usefulness of clopidogrel bisulfate against ischemic cerebrovascular disorders
Scientific Title:Acronym DuaLS study
Region
Japan

Condition
Condition Lacunar stroke
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess usufulness of early treatment with clopidogrel in patients with lacunar stroke
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes mRS score at 90 days
Key secondary outcomes Cardiovascular event
Hemorrhagic compication
Other functional outcome

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
45 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients with written informed consent
2.Patients with ischemic cerebrovascular disease
(1)Supratentorial lacunar infarction
(2)Infarction radiologically diagnosed with MRI or CT
3.Patients who can receive antiplatelet agents orally or with tube feeding
Key exclusion criteria 1) Patients involved in other interventional study/trials
2) Patients treated with cancer, infarction, or febrile disease
3) Patients with atherothrombotic infarction or cardiogenic embolism
4) Patients who have contraindications to clopidogrel written in a package leaflet
5) Patients who have already received clopidogrel
6) Patients who have already received two types of antiplatelet agents or anticoagulants
7) Patients who have already received t-PA
8) Patients who had surgery within 30 days
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Ihara
Organization Kyoto University Hospital
Division name Department of Neurology
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University Hospital
Division name Medical Ethics Committee
Zip code
Address
TEL
Homepage URL
Email ethcom@kuhp.kyoto-u.ac.jp

Sponsor
Institute Masafumi Ihara
Institute
Department

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 YES
Study ID_1 C598
Org. issuing International ID_1 Kyoto University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 京都大学病院

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 12 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 Preinitiation
Date of protocol fixation
2011 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2011 Year 12 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 modified Rankin scale
cardiovascular event
NIHSS
Blood pressure
Drug adherance
Drug side-effects

Management information
Registered date
2011 Year 12 Month 11 Day
Last modified on
2011 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008119

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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