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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Non-ST Elevation Myocardial Infarction

Treatments: Drug: Tirofiban

Study type: Interventional

Funder types: Other

Identifiers

NCT03114995

B-1111-140-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 3 patient groups

Group A (high platelet reactivity - tirofiban)

Experimental group

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

Treatment:

Drug: Tirofiban

Control C1 (high platelet reactivity - no tirofiban)

No Intervention group

Description:

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

Control C2 (low platelet reactivity - no tirofiban)

No Intervention group

Description:

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