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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT01069302
First received: February 16, 2010
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Drug: Clopidogrel
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • Inhibition of platelet aggregation 24 hours after loading [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inhibition of platelet aggregation 7 days after loading [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Inhibition of platelet aggregation 28 days after loading [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • all cause death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • cardiac death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • stent thrombosis (Academic Research Consortium definition) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • acute hemorrhagic or ischemic stroke excluding transient ischemic attack [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • bleeding complications (Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] and Thrombolysis In Myocardial Infarction [TIMI] definition) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • composite of cardiac death, myocardial infarction and stroke [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: February 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: High loading and low maintenance
Clopidogrel loading 600mg and maintenance 75mg for 7days
 Drug: Clopidogrel
Clopidogrel loading 600mg and maintenance 75mg for 7days
Active Comparator: Low loading and high maintenance
Clopidogrel loading 300mg and maintenance 150mg for 7days
 Drug: Clopidogrel
Clopidogrel loading 300mg and maintenance 150mg for 7days
Active Comparator: Low loading and low maintenance
Clopidogrel loading 300mg and maintenance 75mg for 7days
 Drug: Clopidogrel
Clopidogrel loading 300mg and maintenance 75mg for 7days

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069302

Locations
Japan
Division of Cardiology, Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Takeshi Morimoto
Investigators
Principal Investigator: Takeshi Kimura, MD Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
  More Information

No publications provided

Responsible Party: Takeshi Morimoto, Professor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01069302     History of Changes
Other Study ID Numbers: C369
Study First Received: February 16, 2010
Last Updated: July 31, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyoto University, Graduate School of Medicine:
Coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013