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

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ClinicalTrials.gov Identifier: NCT03114995
Recruitment Status : Completed
First Posted : April 14, 2017
Results First Posted : June 8, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Tae-Jin Youn, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Non-ST Elevation Myocardial Infarction Drug: Tirofiban Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Tailored Use of Tirofiban in Patients With Non-ST-elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
Actual Study Start Date : February 1, 2012
Actual Primary Completion Date : October 1, 2015
Actual Study Completion Date : October 1, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A (high platelet reactivity - tirofiban)
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
Drug: Tirofiban
Other Name: Agrastat

No Intervention: Control C1 (high platelet reactivity - no tirofiban)
Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered
No Intervention: Control C2 (low platelet reactivity - no tirofiban)
Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered



Primary Outcome Measures :
  1. Area Under Curve of Serial Cardiac Biomarkers [ Time Frame: 0,6,12,18,24,30,36 hours ]
    An area under the curve of serial levels of Troponin I and creatine kinase-MB isoenzyme during 36 hours


Secondary Outcome Measures :
  1. Percentage of Participants With Periprocedural Myonecrosis [ Time Frame: 0,6,12,18,24,30,36 hours ]

    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.




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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114995


Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Tae-Jin Youn, PhD Seoul National University Bundang Hospital

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tae-Jin Youn, Professor, Cardiovascular Center, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03114995     History of Changes
Other Study ID Numbers: B-1111-140-001
First Posted: April 14, 2017    Key Record Dates
Results First Posted: June 8, 2018
Last Update Posted: July 17, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: not planned

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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
Keywords provided by Tae-Jin Youn, Seoul National University Bundang Hospital:
Tirofiban
Resistance to antiplatelet agents
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Non-ST Elevated Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tirofiban
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors