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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Clopidogrel; Drug: Clopidogrel; Drug: Clopidogrel; Drug: Clopidogrel

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Kyoto, Japan, 606-8507
    • Division of Cardiology, Kyoto University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High loading and high maintenance; Clopidogrel loading 600mg and maintenance 150mg for 7days	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
Active Comparator: High loading and low maintenance; Clopidogrel loading 600mg and maintenance 75mg for 7days	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
Active Comparator: Low loading and high maintenance; Clopidogrel loading 300mg and maintenance 150mg for 7days	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
Active Comparator: Low loading and low maintenance; Clopidogrel loading 300mg and maintenance 75mg for 7days	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Inhibition of platelet aggregation 24 hours after loading	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Takeshi Morimoto
• Investigators: Principal Investigator: Takeshi Kimura, MD, Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 16, 2010
• First Submitted That Met QC Criteria: February 16, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Estimate): January 11, 2016
• Last Update Submitted That Met QC Criteria: January 7, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Coronary artery disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: C369