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OpenTrials
Completed

NCT Number: NCT01069302

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Cardiology, Kyoto University Hospital

Kyoto, 606-8507, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

Clopidogrel loading 600mg and maintenance 150mg for 7days

Primary outcomes

  1. Inhibition of platelet aggregation 24 hours after loading

    Time frame: 24 hours

Secondary outcomes

  1. Inhibition of platelet aggregation 7 days after loading

    Time frame: 7 days

  2. Inhibition of platelet aggregation 28 days after loading

    Time frame: 28 days

  3. all cause death

    Time frame: 1 year

  4. cardiac death

    Time frame: 1 year

  5. myocardial infarction

    Time frame: 1 year

  6. stent thrombosis (Academic Research Consortium definition)

    Time frame: 1 year

  7. acute hemorrhagic or ischemic stroke excluding transient ischemic attack

    Time frame: 1 year

  8. bleeding complications (Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] and Thrombolysis In Myocardial Infarction [TIMI] definition)

    Time frame: 1 year

  9. composite of cardiac death, myocardial infarction and stroke

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Takeshi Morimoto

Other

Registry information

Acronym: CHOICE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2010
Registry last updated
Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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