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

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 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


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

Value
https://center6.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