UMIN-CTR Clinical Trial

Basic information
Public title	Switch from aspirin to clopidogrel in chronic stroke patients
Acronym	SWITCH IT
Scientific Title	Switch from aspirin to clopidogrel in chronic stroke patients
Scientific Title:Acronym	SWITCH IT
Region	Japan

Condition
Condition	Non-cardiac stroke
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and efficacy of Clopidogrel for chronic non-cardiac stroke patients taking Aspirin previously.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of below 1) Any bleedings which should be managed clinically (need to withdraw, reduce the dose and be hospitalized) 2) Using rate of proton pomp inhibitor 3) Rate of continue
Key secondary outcomes	1) Inflammatory or atherosclerosis marker -hs-CRP, ABI/PWV 2) Side effect -Leukopenia, Neutropenia, Thrombocytopenia, hepatic dysfunction -Gastrointestinal dysfunction 3) Moving of Hb 4) Incidence of ischemic events -Ischemic stroke, TIA -Myocardial infarction -Angina(unstable, stable) -Cardiovascular death 5) Incidence of MBs 6) Echo of carotid artery -maxIMT -echogensity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Switch Aspirin to Clopidogrel for chronic non-cardiac stroke patients taking Aspirin.
Interventions/Control_2	Chronic non-cardiac stroke patients taking Aspirin.
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	1) Non-cardiac ischemic stroke patient including asymptomatic ischemic stroke 2) Satisfy the bellow -Taking Aspirin over a month -Definite stroke by CT or MRI -20 years of age or older
Key exclusion criteria	Complications 1) Need to manage by oral anti coagulation, e.g., AF or valvular 2) Active gastric ulcer 3) Symptomatic intra cranial bleeding Drugs 1) Anti platelet dugs -Cilostazol, Aspirin, Ticlopidine, Dipyridamole, Salpoglerate, Ozagrel 2) Anti coagulation drugs -Warfarin, Dabigatoran, Rivaroxaban, Apixaben, Heparin, Argatroban 3) NSAIDs Except for using within 7 days
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinichiro Uchiyama
Organization	Tokyo Womens Medical University Hospital
Division name	The Neurological Institute
Zip code
Address	8-1 Kawada,Shinjuku,Tokyo
TEL	03-3353-8111
Email	suchiyam@nij.twmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiromi Uno
Organization	Tokyo Womens Medical University Hospital
Division name	The Neurological Institute
Zip code
Address	8-1 Kawada,Shinjuku,Tokyo
TEL	03-3353-8111
Homepage URL
Email	terashi@jb3.so-net.ne.jp

Sponsor
Institute	Tokyo Womens Medical University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nippon Medical School Hospital
Name of secondary funder(s)	None

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	東京女子医科大学病院（東京都）、日本医科大学付属病院（東京都）　　　　Tokyo Women’s Medical University Hospital（Tokyo）、Nippon Medical School Hospital（Tokyo）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 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	2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 11 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	2013 Year 09 Month 02 Day
Last modified on	2013 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013592

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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