Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-02-09 @ 10:37 PM
Study NCT ID:
NCT03114995
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2017-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients
Sponsor:
Seoul National University Bundang Hospital
Organization:
Study Overview
Official Title:
Effect of Tailored Use of Tirofiban in Patients With Non-ST-elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: