Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan

Study Overview
=================
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.

Official Title
-----------------
Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Clopidogrel
* Drug: Clopidogrel
* Drug: Clopidogrel
* Drug: Clopidogrel


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High loading and high maintenance<br>Clopidogrel loading 600mg and maintenance 150mg for 7days | Drug: Clopidogrel<br>* Clopidogrel loading 600mg and maintenance 150mg for 7days<br>|
| Active Comparator: High loading and low maintenance<br>Clopidogrel loading 600mg and maintenance 75mg for 7days | Drug: Clopidogrel<br>* Clopidogrel loading 600mg and maintenance 75mg for 7days<br>|
| Active Comparator: Low loading and high maintenance<br>Clopidogrel loading 300mg and maintenance 150mg for 7days | Drug: Clopidogrel<br>* Clopidogrel loading 300mg and maintenance 150mg for 7days<br>|
| Active Comparator: Low loading and low maintenance<br>Clopidogrel loading 300mg and maintenance 75mg for 7days | Drug: Clopidogrel<br>* Clopidogrel loading 300mg and maintenance 75mg for 7days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhibition of platelet aggregation 24 hours after loading |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery disease