UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Adhibition for Clopidogrel loading dose in acute ischemic stroke
Title of the study (Brief title)	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	Kazuo Kitagaza
Organization	Tokyo Women's Medical University
Division name	Department of Neurology
Address	Kawada-cho 8-1, Shinjuku-ku, Tokyo, Japan.
TEL	03-3353-8111
Email	kkitagawa@nij.twmu.ac.jp

Public contact
Name of contact person	Sono Toi
Organization	Tokyo Women's Medical University
Division name	Department of Neurology
Address	Kawada-cho 8-1, Shinjuku-ku, Tokyo, Japan.
TEL	+81-3-3353-8111
Homepage URL
Email	stoi@nij.twmu.ac.jp

Sponsor
Institute	Department of Neurology, Tokyo Women's Medical University
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 03 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025183