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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Clopidogrel

• Registration Number: NCT01069302
• Lead Sponsor: Takeshi Morimoto

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Low loading and high maintenance	Clopidogrel	Clopidogrel loading 300mg and maintenance 150mg for 7days
High loading and high maintenance	Clopidogrel	Clopidogrel loading 600mg and maintenance 150mg for 7days
High loading and low maintenance	Clopidogrel	Clopidogrel loading 600mg and maintenance 75mg for 7days
Low loading and low maintenance	Clopidogrel	Clopidogrel loading 300mg and maintenance 75mg for 7days

Primary Outcome Measures

Name	Time	Method
Inhibition of platelet aggregation 24 hours after loading	24 hours

Secondary Outcome Measures

Name	Time	Method
cardiac death	1 year
bleeding complications (Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] and Thrombolysis In Myocardial Infarction [TIMI] definition)	1 year
Inhibition of platelet aggregation 7 days after loading	7 days
all cause death	1 year
stent thrombosis (Academic Research Consortium definition)	1 year
composite of cardiac death, myocardial infarction and stroke	1 year
Inhibition of platelet aggregation 28 days after loading	28 days
myocardial infarction	1 year
acute hemorrhagic or ischemic stroke excluding transient ischemic attack	1 year

Trial Locations

Locations (1)

Division of Cardiology, Kyoto University Hospital; 🇯🇵 Kyoto, Japan