UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003284
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email jun1@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Kyoto University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003664

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.