UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021840 |
|---|---|
| Receipt number | R000025183 |
| Scientific Title | Adhibition for Clopidogrel loading dose in acute ischemic stroke |
| Date of disclosure of the study information | 2016/04/12 |
| Last modified on | 2018/10/10 15:13:19 |
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Basic information
Public title
Adhibition for Clopidogrel loading dose in acute ischemic stroke
Acronym
CLD in stroke
Scientific Title
Adhibition for Clopidogrel loading dose in acute ischemic stroke
Scientific Title:Acronym
CLD in stroke
Region
| Japan |
Condition
Condition
Acute ischemic stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Test the efficacy and safety of oral clopidogrel 300 mg administration
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemorrhagic complication and recurrent stroke of the start of the onset of ischemic stroke within three weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Clopidogrel 300 mg
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Acute ischemic stroke patients within three days
Key exclusion criteria
pancytopenia
severe liver dysfunction and/or renal dysfunction
hemorrhagic transformation in brain CT or MRI
active hemorrhagic lesion
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Kitagaza |
Organization
Tokyo Women's Medical University
Division name
Department of Neurology
Zip code
Address
Kawada-cho 8-1, Shinjuku-ku, Tokyo, Japan.
TEL
03-3353-8111
kkitagawa@nij.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sono Toi |
Organization
Tokyo Women's Medical University
Division name
Department of Neurology
Zip code
Address
Kawada-cho 8-1, Shinjuku-ku, Tokyo, Japan.
TEL
+81-3-3353-8111
Homepage URL
stoi@nij.twmu.ac.jp
Sponsor or person
Institute
Department of Neurology, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Other
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京女子医科大学 神経内科
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | 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
Management information
Registered date
| 2016 | Year | 04 | Month | 08 | Day |
Last modified on
| 2018 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025183
