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

Takeshi Morimoto

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01069302

C369

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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106 participants in 4 patient groups

High loading and high maintenance

Active Comparator group

Description:

Clopidogrel loading 600mg and maintenance 150mg for 7days

Treatment:

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel

High loading and low maintenance

Active Comparator group

Description:

Clopidogrel loading 600mg and maintenance 75mg for 7days

Treatment:

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel

Low loading and high maintenance

Active Comparator group

Description:

Clopidogrel loading 300mg and maintenance 150mg for 7days

Treatment:

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel

Low loading and low maintenance

Active Comparator group

Description:

Clopidogrel loading 300mg and maintenance 75mg for 7days

Treatment:

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel

Drug: Clopidogrel