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
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
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
NCT ID
NCT03114995
First Posted
April 11, 2017
Last Updated
June 18, 2018
Sponsor
Seoul National University Bundang Hospital
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:
PubMed Identifier
18804738
Citation
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Results Reference
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Citation
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Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients
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