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Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients

Primary Purpose

Non-ST Elevation Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tirofiban
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-ST Elevation Myocardial Infarction focused on measuring Tirofiban, Resistance to antiplatelet agents

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosed with NSTE-ACS who need PCI
  • loaded with aspirin and clopidogrel at least 6 h before the procedure

Exclusion Criteria:

  • thrombocytopenia (platelet count <100,000/μL)
  • history of hemorrhagic stroke
  • history of ischemic stroke in the recent 2 year
  • history of major surgery 6 months prior

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    No Intervention

    No Intervention

    Arm Label

    Group A (high platelet reactivity - tirofiban)

    Control C1 (high platelet reactivity - no tirofiban)

    Control C2 (low platelet reactivity - no tirofiban)

    Arm Description

    Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h

    Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered

    Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered

    Outcomes

    Primary Outcome Measures

    Area Under Curve of Serial Cardiac Biomarkers
    An area under the curve of serial levels of Troponin I and creatine kinase-MB isoenzyme during 36 hours

    Secondary Outcome Measures

    Percentage of Participants With Periprocedural Myonecrosis
    Percentage of participants with periprocedural myonecrosis under the criteria described below. When the cardiac biomarkers before the procedure were within the 99th percentile upper reference limit (URL), more than a 5-fold elevation in the URL within 12 hours after percutaneous coronary intervention (PCI) was defined as periprocedural myonecrosis. If the cardiac biomarker level was already above the 99th percentile URL before the procedure and the trend was stationary or decreasing, a ≥20% increase compared to the previous level was considered periprocedural myonecrosis. If the trend was still increasing, the levels at the post-6 hour and 12-hour were compared to determine periprocedural myonecrosis.

    Full Information

    First Posted
    April 11, 2017
    Last Updated
    June 18, 2018
    Sponsor
    Seoul National University Bundang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03114995
    Brief Title
    Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients
    Official Title
    Effect of Tailored Use of Tirofiban in Patients With Non-ST-elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2012 (Actual)
    Primary Completion Date
    October 1, 2015 (Actual)
    Study Completion Date
    October 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Bundang Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Investigators aimed to test the beneficial effect of tirofiban, a GPIIb/IIIa antagonist, for Non-ST-Elevation Acute Coronary Syndrome Patients who has high resistance to clopidogrel.
    Detailed Description
    Some patients have a poor response to dual antiplatelet therapy (DAPT), and it can result in a poor prognosis after percutaneous coronary intervention (PCI). Devices like Ultegra Rapid Platelet Function Analyzer (VerifyNow®) enable us to quantify platelet reactivity quickly in the catheter laboratory. This means that the poor responders to DAPT can be identified, and the patients' outcomes can be improved by providing additional antiplatelet agents. Tirofiban, a GP IIb/IIIa inhibitor, is a potent antiplatelet agent which is recommended for Non-ST-Elevation acute coronary syndrome (NSTE-ACS) with high risk at presentation. However, its role is not clear for patients stabilized with standard medical treatment but with a poor responsiveness to DAPT. In this study, Investigators administered tirofiban on top of DAPT to patients with NSTE-ACS undergoing PCI who have a high platelet reactivity (HPR) identified by VerifyNow. To the best of our knowledge, there are few studies conducted with tirofiban for tailored antiplatelet therapy. Moreover, this is the first randomized study with NSTE-ACS patients for tailored use of tirofiban under the guidance of platelet reactivity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-ST Elevation Myocardial Infarction
    Keywords
    Tirofiban, Resistance to antiplatelet agents

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A (high platelet reactivity - tirofiban)
    Arm Type
    Experimental
    Arm Description
    Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h
    Arm Title
    Control C1 (high platelet reactivity - no tirofiban)
    Arm Type
    No Intervention
    Arm Description
    Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered
    Arm Title
    Control C2 (low platelet reactivity - no tirofiban)
    Arm Type
    No Intervention
    Arm Description
    Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
    Intervention Type
    Drug
    Intervention Name(s)
    Tirofiban
    Other Intervention Name(s)
    Agrastat
    Primary Outcome Measure Information:
    Title
    Area Under Curve of Serial Cardiac Biomarkers
    Description
    An area under the curve of serial levels of Troponin I and creatine kinase-MB isoenzyme during 36 hours
    Time Frame
    0,6,12,18,24,30,36 hours
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Periprocedural Myonecrosis
    Description
    Percentage of participants with periprocedural myonecrosis under the criteria described below. When the cardiac biomarkers before the procedure were within the 99th percentile upper reference limit (URL), more than a 5-fold elevation in the URL within 12 hours after percutaneous coronary intervention (PCI) was defined as periprocedural myonecrosis. If the cardiac biomarker level was already above the 99th percentile URL before the procedure and the trend was stationary or decreasing, a ≥20% increase compared to the previous level was considered periprocedural myonecrosis. If the trend was still increasing, the levels at the post-6 hour and 12-hour were compared to determine periprocedural myonecrosis.
    Time Frame
    0,6,12,18,24,30,36 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosed with NSTE-ACS who need PCI loaded with aspirin and clopidogrel at least 6 h before the procedure Exclusion Criteria: thrombocytopenia (platelet count <100,000/μL) history of hemorrhagic stroke history of ischemic stroke in the recent 2 year history of major surgery 6 months prior
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tae-Jin Youn, PhD
    Organizational Affiliation
    Seoul National University Bundang Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    not planned
    Citations:
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    18804738
    Citation
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    Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients

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