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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High loading and high maintenance

Clopidogrel loading 600mg and maintenance 150mg for 7days

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Clopidogrel loading 600mg and maintenance 150mg for 7days

High loading and low maintenance

Clopidogrel loading 600mg and maintenance 75mg for 7days

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Clopidogrel loading 600mg and maintenance 75mg for 7days

Low loading and high maintenance

Clopidogrel loading 300mg and maintenance 150mg for 7days

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Clopidogrel loading 300mg and maintenance 150mg for 7days

Low loading and low maintenance

Clopidogrel loading 300mg and maintenance 75mg for 7days

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Clopidogrel loading 300mg and maintenance 75mg for 7days

Interventions

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Clopidogrel

Clopidogrel loading 600mg and maintenance 150mg for 7days

Intervention Type DRUG

Clopidogrel

Clopidogrel loading 600mg and maintenance 75mg for 7days

Intervention Type DRUG

Clopidogrel

Clopidogrel loading 300mg and maintenance 150mg for 7days

Intervention Type DRUG

Clopidogrel

Clopidogrel loading 300mg and maintenance 75mg for 7days

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No