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.
Dual antiplatelet therapy of aspirin and thienopyridine is used to prevent stent thrombosis after percutaneous coronary intervention (PCI). Clopidogrel is the most popular thienopyridine. Following the 300mg clopidogrel loading dose (LD) at first day, patients take 75mg maintenance dose (MD) to inhibit platelet aggregation after coronary stent implantation. 600mg high LD inhibit platelet aggregation more rapidly and strongly than standard LD and prevent thrombotic event around the PCI. Similarly high MD inhibit platelet aggregation more strongly. Interindividual variability of clopidogrel anti-platelet effect has been reported. In Japanese, there are many non or hyporesponders to clopidogrel compared to the Western population. 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 PCI due to ischemic heart disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Clopidogrel loading 600mg and maintenance 150mg for 7days
Clopidogrel loading 600mg and maintenance 75mg for 7days
Clopidogrel loading 300mg and maintenance 150mg for 7days
Division of Cardiology, Kyoto University Hospital
Kyoto, Kyoto, Japan
Inhibition of platelet aggregation 24 hours after loading
Time frame: 24 hours
Inhibition of platelet aggregation 7 days after loading
Time frame: 7 days
Inhibition of platelet aggregation 28 days after loading
Time frame: 28 days
all cause death
Time frame: 1 year
cardiac death
Time frame: 1 year
myocardial infarction
Time frame: 1 year
stent thrombosis (Academic Research Consortium definition)
Time frame: 1 year
acute hemorrhagic or ischemic stroke excluding transient ischemic attack
Time frame: 1 year
bleeding complications (Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] and Thrombolysis In Myocardial Infarction [TIMI] definition)
Time frame: 1 year
composite of cardiac death, myocardial infarction and stroke
Time frame: 1 year
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Clopidogrel loading 300mg and maintenance 75mg for 7days