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

Coronary Artery Disease Clinical Trial

— CHOICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069302
• Other study ID #: C369
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2010
• Last updated: January 7, 2016
• Start date: February 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2016
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Clopidogrel
Clopidogrel loading 600mg and maintenance 150mg for 7days
• Clopidogrel
Clopidogrel loading 600mg and maintenance 75mg for 7days
• Clopidogrel
Clopidogrel loading 300mg and maintenance 150mg for 7days
• Clopidogrel
Clopidogrel loading 300mg and maintenance 75mg for 7days

Locations

Country	Name	City	State
Japan	Division of Cardiology, Kyoto University Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Takeshi Morimoto

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inhibition of platelet aggregation 24 hours after loading		24 hours	No
Secondary	Inhibition of platelet aggregation 7 days after loading		7 days	No
Secondary	Inhibition of platelet aggregation 28 days after loading		28 days	No
Secondary	all cause death		1 year	No
Secondary	cardiac death		1 year	No
Secondary	myocardial infarction		1 year	No
Secondary	stent thrombosis (Academic Research Consortium definition)		1 year	No
Secondary	acute hemorrhagic or ischemic stroke excluding transient ischemic attack		1 year	No
Secondary	bleeding complications (Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] and Thrombolysis In Myocardial Infarction [TIMI] definition)		1 year	No
Secondary	composite of cardiac death, myocardial infarction and stroke		1 year	No