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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Clopidogrel
Clopidogrel
Clopidogrel
Clopidogrel
Sponsored by
Takeshi Morimoto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Division of Cardiology, Kyoto University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

High loading and high maintenance

High loading and low maintenance

Low loading and high maintenance

Low loading and low maintenance

Arm Description

Clopidogrel loading 600mg and maintenance 150mg for 7days

Clopidogrel loading 600mg and maintenance 75mg for 7days

Clopidogrel loading 300mg and maintenance 150mg for 7days

Clopidogrel loading 300mg and maintenance 75mg for 7days

Outcomes

Primary Outcome Measures

Inhibition of platelet aggregation 24 hours after loading

Secondary Outcome Measures

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

Full Information

First Posted
February 16, 2010
Last Updated
January 7, 2016
Sponsor
Takeshi Morimoto
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1. Study Identification

Unique Protocol Identification Number
NCT01069302
Brief Title
Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan
Acronym
CHOICE
Official Title
Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Takeshi Morimoto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High loading and high maintenance
Arm Type
Active Comparator
Arm Description
Clopidogrel loading 600mg and maintenance 150mg for 7days
Arm Title
High loading and low maintenance
Arm Type
Active Comparator
Arm Description
Clopidogrel loading 600mg and maintenance 75mg for 7days
Arm Title
Low loading and high maintenance
Arm Type
Active Comparator
Arm Description
Clopidogrel loading 300mg and maintenance 150mg for 7days
Arm Title
Low loading and low maintenance
Arm Type
Active Comparator
Arm Description
Clopidogrel loading 300mg and maintenance 75mg for 7days
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel loading 600mg and maintenance 150mg for 7days
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel loading 600mg and maintenance 75mg for 7days
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel loading 300mg and maintenance 150mg for 7days
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel loading 300mg and maintenance 75mg for 7days
Primary Outcome Measure Information:
Title
Inhibition of platelet aggregation 24 hours after loading
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Inhibition of platelet aggregation 7 days after loading
Time Frame
7 days
Title
Inhibition of platelet aggregation 28 days after loading
Time Frame
28 days
Title
all cause death
Time Frame
1 year
Title
cardiac death
Time Frame
1 year
Title
myocardial infarction
Time Frame
1 year
Title
stent thrombosis (Academic Research Consortium definition)
Time Frame
1 year
Title
acute hemorrhagic or ischemic stroke excluding transient ischemic attack
Time Frame
1 year
Title
bleeding complications (Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] and Thrombolysis In Myocardial Infarction [TIMI] definition)
Time Frame
1 year
Title
composite of cardiac death, myocardial infarction and stroke
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Kimura, MD
Organizational Affiliation
Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology, Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan

12. IPD Sharing Statement

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

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