Coronary Artery Disease
Conditions
Keywords
Coronary artery disease
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.
Detailed description
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.
Interventions
DRUGClopidogrel
Clopidogrel loading 600mg and maintenance 150mg for 7days
Sponsors
Takeshi Morimoto
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for percutaneous coronary intervention due to ischemic heart disease * Patients taking aspirin 81-100mg at least 1 week.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inhibition of platelet aggregation 24 hours after loading | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| stent thrombosis (Academic Research Consortium definition) | 1 year |
| acute hemorrhagic or ischemic stroke excluding transient ischemic attack | 1 year |
| bleeding complications (Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] and Thrombolysis In Myocardial Infarction [TIMI] definition) | 1 year |
| composite of cardiac death, myocardial infarction and stroke | 1 year |
Countries
Japan
Outcome results
None listed