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Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
aspirin + pregrel (Clopidogrel resinate)
aspirin + placebo
aspirin + plavix (Clopidogrel bisulfate)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring CHD, CHD equivalents

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Korean men and women aged 20 to 85 years with coronary heart disease (CHD) or CHD equivalent patients
  • Atherosclerotic plaques in coronary computed tomography (CT) or angiography or
  • History of PCI or coronary artery bypass graft surgery (CABG) > one year or
  • Diabetes mellitus (including type I and type II) or
  • Confirmed carotid atherosclerotic plaque with sonography, CT or angiography or
  • History of peripheral artery disease or
  • History of cerebrovascular disease

Exclusion Criteria:

  • Patients who had history of PCI within one year
  • Patients who used concomitant anticoagulants
  • Patients who had hypersensitivity to aspirin or clopidogrel, serious bleeding tendency, history of intracranial hemorrhage, sign of active bleeding, uncontrolled hypertension
  • Chronic alcoholism or drug addiction
  • Women who were pregnant or breastfeeding or who were not using an effective method of contraception
  • The use of glycoprotein IIb/IIIa inhibitor, daily NSAIDs, lipid lowering agent (except atorvastatin), or substances with possible interactions with the study drug

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    aspirin+placebo

    aspirin+pregrel

    Aspirin+Plavix

    Arm Description

    aspirin protect (Bayer) 100mg + placebo clopidogrel 75mg for 1mo

    pregrel is a generic brand name of clopidogrel

    plavix is a original brand name of clopidogrel

    Outcomes

    Primary Outcome Measures

    The percentage of P2Y12 receptor inhibition assessed by Ultegra rapid platelet function analyzer, (Baseline platelet reaction unit (PRU)- posttreatment PRU)/Baseline PRU * 100 (%))

    Secondary Outcome Measures

    Adverse events after study medication

    Full Information

    First Posted
    July 25, 2009
    Last Updated
    October 12, 2016
    Sponsor
    Seoul National University Hospital
    Collaborators
    CKD Pharmaceutical Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00947843
    Brief Title
    Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents
    Official Title
    Assessment of the Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents : A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2013 (undefined)
    Primary Completion Date
    October 2016 (Actual)
    Study Completion Date
    October 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital
    Collaborators
    CKD Pharmaceutical Limited

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the efficacy and tolerability between clopidogrel resinate and clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD equivalents.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Heart Disease
    Keywords
    CHD, CHD equivalents

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    aspirin+placebo
    Arm Type
    Placebo Comparator
    Arm Description
    aspirin protect (Bayer) 100mg + placebo clopidogrel 75mg for 1mo
    Arm Title
    aspirin+pregrel
    Arm Type
    Active Comparator
    Arm Description
    pregrel is a generic brand name of clopidogrel
    Arm Title
    Aspirin+Plavix
    Arm Type
    Active Comparator
    Arm Description
    plavix is a original brand name of clopidogrel
    Intervention Type
    Drug
    Intervention Name(s)
    aspirin + pregrel (Clopidogrel resinate)
    Other Intervention Name(s)
    Aspirin: Aspirin Protect (Bayer) 100mg, Pregrel: Clopidogrel resinate (CKD Pharmaceutical) 75mg
    Intervention Type
    Drug
    Intervention Name(s)
    aspirin + placebo
    Intervention Type
    Drug
    Intervention Name(s)
    aspirin + plavix (Clopidogrel bisulfate)
    Other Intervention Name(s)
    aspirin : Aspirin Protect (Bayer) 100mg, plavix : Clopidogrel bisulfate (Sanofi-Aventis) 75mg
    Primary Outcome Measure Information:
    Title
    The percentage of P2Y12 receptor inhibition assessed by Ultegra rapid platelet function analyzer, (Baseline platelet reaction unit (PRU)- posttreatment PRU)/Baseline PRU * 100 (%))
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Adverse events after study medication
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Korean men and women aged 20 to 85 years with coronary heart disease (CHD) or CHD equivalent patients Atherosclerotic plaques in coronary computed tomography (CT) or angiography or History of PCI or coronary artery bypass graft surgery (CABG) > one year or Diabetes mellitus (including type I and type II) or Confirmed carotid atherosclerotic plaque with sonography, CT or angiography or History of peripheral artery disease or History of cerebrovascular disease Exclusion Criteria: Patients who had history of PCI within one year Patients who used concomitant anticoagulants Patients who had hypersensitivity to aspirin or clopidogrel, serious bleeding tendency, history of intracranial hemorrhage, sign of active bleeding, uncontrolled hypertension Chronic alcoholism or drug addiction Women who were pregnant or breastfeeding or who were not using an effective method of contraception The use of glycoprotein IIb/IIIa inhibitor, daily NSAIDs, lipid lowering agent (except atorvastatin), or substances with possible interactions with the study drug
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ki-Bae Seung, MD, PhD
    Organizational Affiliation
    Seoul St. Mary's Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Chung-Hwan Gwak, MD, PhD
    Organizational Affiliation
    Gyeongsang National University Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Kwon-Sam Kim, MD,PhD
    Organizational Affiliation
    Kyung Hee University Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Soon-Jun Hong, MD,PhD
    Organizational Affiliation
    Korea University Anam Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Tae-Ho Park, MD,PhD
    Organizational Affiliation
    Dong-A medical center
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Sang-Hyun Kim, MD,PhD
    Organizational Affiliation
    Seoul Metropolitan Boramae Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Seung-Jea Tahk, MD,PhD
    Organizational Affiliation
    Ajou University Medical Center
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Seung-Jae Joo, MD,PhD
    Organizational Affiliation
    Jeju National University Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Young-Jin Choi, MD,PhD
    Organizational Affiliation
    Hallym University Medical Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21816478
    Citation
    Suh JW, Seung KB, Gwak CH, Kim KS, Hong SJ, Park TH, Kim SH, Choi YJ, Joo SJ, Tahk SJ, Kim HS. Comparison of antiplatelet effect and tolerability of clopidogrel resinate with clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD-equivalent risks: a phase IV, prospective, double-dummy, parallel-group, 4-week noninferiority trial. Clin Ther. 2011 Aug;33(8):1057-68. doi: 10.1016/j.clinthera.2011.07.001. Epub 2011 Aug 4.
    Results Reference
    derived

    Learn more about this trial

    Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents

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