Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan
CHOICE
1 other identifier
interventional
106
1 country
1
Brief Summary
The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for percutaneous coronary intervention due to ischemic heart disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 coronary-artery-disease
Started Feb 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJanuary 11, 2016
January 1, 2016
1.7 years
February 16, 2010
January 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inhibition of platelet aggregation 24 hours after loading
24 hours
Secondary Outcomes (9)
Inhibition of platelet aggregation 7 days after loading
7 days
Inhibition of platelet aggregation 28 days after loading
28 days
all cause death
1 year
cardiac death
1 year
myocardial infarction
1 year
- +4 more secondary outcomes
Study Arms (4)
High loading and high maintenance
ACTIVE COMPARATORClopidogrel loading 600mg and maintenance 150mg for 7days
High loading and low maintenance
ACTIVE COMPARATORClopidogrel loading 600mg and maintenance 75mg for 7days
Low loading and high maintenance
ACTIVE COMPARATORClopidogrel loading 300mg and maintenance 150mg for 7days
Low loading and low maintenance
ACTIVE COMPARATORClopidogrel loading 300mg and maintenance 75mg for 7days
Interventions
Clopidogrel loading 600mg and maintenance 150mg for 7days
Eligibility Criteria
You may qualify if:
- Patients scheduled for percutaneous coronary intervention due to ischemic heart disease
- Patients taking aspirin 81-100mg at least 1 week.
You may not qualify if:
- Patients with ST elevation myocardial infarction
- Patients have contraindication of aspirin or clopidogrel
- Patients taking warfarin
- Patients received thrombolytic therapy within 2 weeks
- Patients taking anti-platelet agents except aspirin within 1 month
- Patients taking corticosteroid.
- Patients taking proton pump inhibitor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takeshi Morimotolead
Study Sites (1)
Division of Cardiology, Kyoto University Hospital
Kyoto, Kyoto, 606-8507, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Takeshi Kimura, MD
Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 17, 2010
Study Start
February 1, 2010
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
January 11, 2016
Record last verified: 2016-01