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Trial to Assess the Efficacy of Combination Formula of Aspirin Plus Clopidogrel in Patients With Coronary Stent

Primary Purpose

ANEURYSM CORONARY ARTERY

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Clopirin 1
Clopidogrel-Aspirin(co-administration) 1
Clopirin 2
Clopidogrel-Aspirin(co-administration) 2
Sponsored by
Jeil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ANEURYSM CORONARY ARTERY

Eligibility Criteria

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

Inclusion Criteria:

  • Over 3 months, the patient who were the administration of aspirin or the co-administration of clopidogrel-aspirin coronary artery patients after treated with Percutaneous Coronary Intervention(PCI) that have safety progress.
  • Korean men and women between the age of 20 and 85
  • Patients who understand the study requirements, are willing to comply with all study procedures and have provided written informed consent.

Exclusion Criteria:

  • Patients who were not treated with PCI or intended to treat with PCI but failed.
  • Patients who were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days.
  • Patients who had a history of alcohol abuse or intoxication.
  • Patients who had hypersensitivity to clopidogrel or aspirin.
  • Patients who had severe hepatic dysfunction aspartate aminotransferase(AST) or alanine aminotransferase(ALT) > 3 times upper normal reference values.
  • Patients who had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding - surgery within 48hr, platelet counts below 50,000/mm3 in laboratory tests.
  • Patients who were pregnant, breastfeeding.
  • Patients who were not using effective methods of contraception. (proper contraception : hormonal contraception, condom, intrauterine device, spermicide)
  • Patients who medically, psychologically had investigational product administration's prohibition.
  • Patients who were not participated in this clinical trial decided by other investigators.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    Clopirin 1

    Clopidogrel/Aspirin co-administration 1

    Clopirin 2

    Clopidogrel/Aspirin co-administration 2

    Arm Description

    Clopirin single-administration. Before this clinical trial Clopidogrel/Aspirin co-administration.

    Clopidogrel-aspirin co-administration. Before this clinical trialClopidogrel/Aspirin co-administration.

    Clopirin single-administration. Before this clinical trial Aspirin single-administration.

    Clopidogrel-aspirin-co-administration. Before this clinical trial Aspirin single-administration.

    Outcomes

    Primary Outcome Measures

    % inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU

    Secondary Outcome Measures

    △ PRU = Post treatment PRU - Pre treatment PRU
    △ ARU = Post treatment Aspirin resistance unit(ARU) - Pre treatment ARU

    Full Information

    First Posted
    March 19, 2015
    Last Updated
    March 12, 2017
    Sponsor
    Jeil Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02410083
    Brief Title
    Trial to Assess the Efficacy of Combination Formula of Aspirin Plus Clopidogrel in Patients With Coronary Stent
    Official Title
    Multicenter, Randomized, Open Study, Investigator-initiated Trial for Comparison of Eight Weeks Efficacy and Tolerability of Clopirin and Clopidogrel With Aspirin in Korean Patients With Post-Percutaneous Coronary Artery Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jeil Pharmaceutical Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study in to evaluate efficacy and tolerability of Clopirin and clopidogrel with aspirin in Korean Patients with post-percutaneous coronary artery intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ANEURYSM CORONARY ARTERY

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Clopirin 1
    Arm Type
    Experimental
    Arm Description
    Clopirin single-administration. Before this clinical trial Clopidogrel/Aspirin co-administration.
    Arm Title
    Clopidogrel/Aspirin co-administration 1
    Arm Type
    Active Comparator
    Arm Description
    Clopidogrel-aspirin co-administration. Before this clinical trialClopidogrel/Aspirin co-administration.
    Arm Title
    Clopirin 2
    Arm Type
    Experimental
    Arm Description
    Clopirin single-administration. Before this clinical trial Aspirin single-administration.
    Arm Title
    Clopidogrel/Aspirin co-administration 2
    Arm Type
    Active Comparator
    Arm Description
    Clopidogrel-aspirin-co-administration. Before this clinical trial Aspirin single-administration.
    Intervention Type
    Drug
    Intervention Name(s)
    Clopirin 1
    Intervention Type
    Drug
    Intervention Name(s)
    Clopidogrel-Aspirin(co-administration) 1
    Intervention Type
    Drug
    Intervention Name(s)
    Clopirin 2
    Intervention Type
    Drug
    Intervention Name(s)
    Clopidogrel-Aspirin(co-administration) 2
    Primary Outcome Measure Information:
    Title
    % inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    △ PRU = Post treatment PRU - Pre treatment PRU
    Time Frame
    8 weeks
    Title
    △ ARU = Post treatment Aspirin resistance unit(ARU) - Pre treatment ARU
    Time Frame
    8 weeks

    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: Over 3 months, the patient who were the administration of aspirin or the co-administration of clopidogrel-aspirin coronary artery patients after treated with Percutaneous Coronary Intervention(PCI) that have safety progress. Korean men and women between the age of 20 and 85 Patients who understand the study requirements, are willing to comply with all study procedures and have provided written informed consent. Exclusion Criteria: Patients who were not treated with PCI or intended to treat with PCI but failed. Patients who were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days. Patients who had a history of alcohol abuse or intoxication. Patients who had hypersensitivity to clopidogrel or aspirin. Patients who had severe hepatic dysfunction aspartate aminotransferase(AST) or alanine aminotransferase(ALT) > 3 times upper normal reference values. Patients who had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding - surgery within 48hr, platelet counts below 50,000/mm3 in laboratory tests. Patients who were pregnant, breastfeeding. Patients who were not using effective methods of contraception. (proper contraception : hormonal contraception, condom, intrauterine device, spermicide) Patients who medically, psychologically had investigational product administration's prohibition. Patients who were not participated in this clinical trial decided by other investigators.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hyo-soo Kim, Professor
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Trial to Assess the Efficacy of Combination Formula of Aspirin Plus Clopidogrel in Patients With Coronary Stent

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