Clinical trial NCT01069302: Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan
Official title: Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2010-02-17
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inhibition of platelet aggregation 24 hours after loading
timeFrame: 24 hours
Secondary outcomes:
measure: Inhibition of platelet aggregation 7 days after loading
timeFrame: 7 days
measure: Inhibition of platelet aggregation 28 days after loading
timeFrame: 28 days
measure: all cause death
timeFrame: 1 year
measure: cardiac death
timeFrame: 1 year
measure: myocardial infarction
timeFrame: 1 year
measure: stent thrombosis (Academic Research Consortium definition)
timeFrame: 1 year
measure: acute hemorrhagic or ischemic stroke excluding transient ischemic attack
timeFrame: 1 year
measure: bleeding complications (Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] and Thrombolysis In Myocardial Infarction [TIMI] definition)
timeFrame: 1 year
measure: composite of cardiac death, myocardial infarction and stroke
timeFrame: 1 year
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Division of Cardiology, Kyoto University Hospital
Study officials:
affiliation: Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
name: Takeshi Kimura, MD
role: PRINCIPAL_INVESTIGATOR
References: