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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-01

Study Completion Date

2015-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type EXPERIMENTAL

Tirofiban

Intervention Type DRUG

Control C1 (high platelet reactivity - no tirofiban)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Control C2 (low platelet reactivity - no tirofiban)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tirofiban

Intervention Type DRUG

Other Intervention Names

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Agrastat

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No