UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011634 |
|---|---|
| Receipt number | R000013592 |
| Scientific Title | Switch from aspirin to clopidogrel in chronic stroke patients |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2013/09/02 21:58:07 |
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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
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
terashi@jb3.so-net.ne.jp
Sponsor or person
Institute
Tokyo Womens Medical University Hospital
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
Nippon Medical School Hospital
Name of secondary funder(s)
None
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013592
