UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003284 |
|---|---|
| Receipt number | R000003664 |
| Scientific Title | Clopidgrel high dose evaluation for the patIent with coronary artery disease in Japan (CHOICE) |
| Date of disclosure of the study information | 2010/03/03 |
| Last modified on | 2012/10/01 13:52:51 |
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Basic information
Public title
Clopidgrel high dose evaluation for the patIent with coronary artery disease in Japan (CHOICE)
Acronym
CHOICE study
Scientific Title
Clopidgrel high dose evaluation for the patIent with coronary artery disease in Japan (CHOICE)
Scientific Title:Acronym
CHOICE study
Region
| Japan |
Condition
Condition
The patient scheduled to undergo percutaneous coronary intervention due to ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy of high dose clopidgrel in Japanese patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Inhibition of platelet aggregation after 24 hours since the clopidgrel loading
Key secondary outcomes
Inhibition of platelet aggregation after a week since the clopidgrel loading
The clinical and adverse event at 28 days after the PCI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patient are randomized in two loading dose groups.
a) clopidgrel loading dose 300mg
b) clopidgrel loading dose 600mg
Interventions/Control_2
The patient are randomized in two maintenance dose groups.
i) clopidgrel maintenance dose 75mg/day
ii) clopidgrel maintenance dose 150mg/day
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient,who are suspected ischemic heart disease due to examination or symptom, taking low dose aspirin over a week. The patient scheduled to undergo the percutaneous coronary intervention.
Key exclusion criteria
the patient of ST elevation myocardial infarction
the patient of Contraindication of aspirin or clopidgrel
the patient undergoing anticoagulation with coumadin
the patient who underwent thrombolysis within 2 weeks
the patient who underwent antiplatelet therapy besides aspirin
the patient who taking corticosteroid
the patient who taking proton pump inhibitor
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kimura |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-4255
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Tazaki |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-4255
Homepage URL
jun1@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Research Institute for Production Development
Organization
Division
Category of Funding Organization
Non profit foundation
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
日本大学医学部附属板橋病院(東京都)、医療法人社団冠心会大崎病院 東京ハートセンター（東京都）、国立大学法人三重大学医学部附属病院（三重県）、群馬県立心臓血管センター（群馬県）、国立病院機構 京都医療センター（京都府）、天理よろづ相談所病院（奈良県）、京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | 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
| 2010 | Year | 03 | Month | 03 | Day |
Last modified on
| 2012 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003664
