UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006870 |
|---|---|
| Receipt number | 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 | 2023/12/19 09:08:40 |
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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
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
ethcom@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Masafumi Ihara
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
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
Terminated
Date of protocol fixation
| 2011 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2011 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 06 | Day |
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
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008119
