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Comparison of Effect & Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients

Primary Purpose

Coronary Artery Disease (CAD)

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Clopidogrel
aspirin 100mg
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease (CAD)

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged 20 to 80 years
  • men and women with coronary artery disease who had been treated with drug-eluting stent placement before > 12 months
  • patients who had remained in a stable condition with a single antiplatelet agent, aspirin
  • patients who did not show any sign or symptom of the worsening of their angina within the last six months that required a coronary artery intervention, a coronary artery bypass, or coronary angiography

Exclusion Criteria:

  • Patients who were taking another antiplatelet or anticoagulant drug such as clopidogrel, warfarin, or cilostazol in addition to aspirin, unless they could withdraw from such other drug/s, in which case they could be enrolled in the study after a two-week wash-out period
  • Patients who were suffering from drug abuse or alcohol addiction
  • hypersensitivity to clopidogrel or aspirin
  • severe liver disease (ALT or AST ≥ 10 times the upper normal limit)
  • active hemorrhage such as gastro-intestinal ulcer or intracranial hemorrhage
  • a high risk of bleeding (blood coagulation disorder, uncontrolled severe hypertension, active bleeding, or history of severe bleeding)
  • pregnant or lactating women
  • women with childbearing potential who were not using an appropriate contraception method
  • had medical or mental contra-indications to the study treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Clopidogrel napadisilate

    clopidogrel bisulfate

    Arm Description

    aspirin 100mg

    aspirin 100mg

    Outcomes

    Primary Outcome Measures

    the percent inhibition of the platelet aggregation change

    Secondary Outcome Measures

    the change of P2Y12 reaction unit (PRU)

    Full Information

    First Posted
    April 5, 2013
    Last Updated
    October 10, 2016
    Sponsor
    Hanmi Pharmaceutical Company Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01830491
    Brief Title
    Comparison of Effect & Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients
    Official Title
    Comparison of Antiplatelet Effect and Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients: Multi-center, Randomized, Double-blind, Phase IV Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    December 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hanmi Pharmaceutical Company Limited

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to demonstrate that the combination therapy of aspirin and clopidogrel napadisilate is not inferior to that of aspirin and clopidogrel bisulfate with respect to its effectiveness in inhibiting platelet aggregation, if it is given for four weeks to Coronary Artery Disease (CAD) patients who had been treated with a drug-eluting stent before > 12 months and had remained in a stable condition with a single antiplatelet agent, aspirin.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease (CAD)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    162 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Clopidogrel napadisilate
    Arm Type
    Experimental
    Arm Description
    aspirin 100mg
    Arm Title
    clopidogrel bisulfate
    Arm Type
    Active Comparator
    Arm Description
    aspirin 100mg
    Intervention Type
    Drug
    Intervention Name(s)
    Clopidogrel
    Other Intervention Name(s)
    Pidogul®, Plavix®
    Intervention Type
    Drug
    Intervention Name(s)
    aspirin 100mg
    Primary Outcome Measure Information:
    Title
    the percent inhibition of the platelet aggregation change
    Time Frame
    baseline and 4weeks
    Secondary Outcome Measure Information:
    Title
    the change of P2Y12 reaction unit (PRU)
    Time Frame
    baseline and 4weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aged 20 to 80 years men and women with coronary artery disease who had been treated with drug-eluting stent placement before > 12 months patients who had remained in a stable condition with a single antiplatelet agent, aspirin patients who did not show any sign or symptom of the worsening of their angina within the last six months that required a coronary artery intervention, a coronary artery bypass, or coronary angiography Exclusion Criteria: Patients who were taking another antiplatelet or anticoagulant drug such as clopidogrel, warfarin, or cilostazol in addition to aspirin, unless they could withdraw from such other drug/s, in which case they could be enrolled in the study after a two-week wash-out period Patients who were suffering from drug abuse or alcohol addiction hypersensitivity to clopidogrel or aspirin severe liver disease (ALT or AST ≥ 10 times the upper normal limit) active hemorrhage such as gastro-intestinal ulcer or intracranial hemorrhage a high risk of bleeding (blood coagulation disorder, uncontrolled severe hypertension, active bleeding, or history of severe bleeding) pregnant or lactating women women with childbearing potential who were not using an appropriate contraception method had medical or mental contra-indications to the study treatment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Byung-Hee Oh, MD, PhD
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23913405
    Citation
    Lee S, Lee HY, Park KW, Kang HJ, Koo BK, Kim HS, Choi DJ, Kim MA, Oh BH. Comparison of antiplatelet effect and safety of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients: multi-center, randomized, double-blind, phase IV, non-inferiority clinical trial. Am J Cardiovasc Drugs. 2013 Dec;13(6):413-24. doi: 10.1007/s40256-013-0039-y.
    Results Reference
    derived

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    Comparison of Effect & Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients

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