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

Study Overview
=================
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.

Official Title
-----------------
Effect of Tailored Use of Tirofiban in Patients With Non-ST-elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Conditions
-----------------
Non-ST Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Tirofiban


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (high platelet reactivity - tirofiban)<br>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<br> <br> * Other names: Agrastat;|
| No Intervention: Control C1 (high platelet reactivity - no tirofiban)<br>Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered | |
| No Intervention: Control C2 (low platelet reactivity - no tirofiban)<br>Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 0,6,12,18,24,30,36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0,6,12,18,24,30,36 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tirofiban, Resistance to antiplatelet agents