NCT01069302

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Takeshi Morimoto · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Clopidogrel	Clopidogrel loading 600mg and maintenance 150mg for 7days
DRUG	Clopidogrel	Clopidogrel loading 600mg and maintenance 75mg for 7days
DRUG	Clopidogrel	Clopidogrel loading 300mg and maintenance 150mg for 7days
DRUG	Clopidogrel	Clopidogrel loading 300mg and maintenance 75mg for 7days

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2010-02-17
• Last updated: 2016-01-11

Locations

1 site across 1 country: Japan