Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients
|ClinicalTrials.gov Identifier: NCT03114995|
Recruitment Status : Completed
First Posted : April 14, 2017
Results First Posted : June 8, 2018
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-ST Elevation Myocardial Infarction||Drug: Tirofiban||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Effect of Tailored Use of Tirofiban in Patients With Non-ST-elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention|
|Actual Study Start Date :||February 1, 2012|
|Actual Primary Completion Date :||October 1, 2015|
|Actual Study Completion Date :||October 1, 2015|
Experimental: 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
Other Name: Agrastat
No Intervention: Control C1 (high platelet reactivity - no tirofiban)
Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered
No Intervention: Control C2 (low platelet reactivity - no tirofiban)
Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
- Area Under Curve of Serial Cardiac Biomarkers [ Time Frame: 0,6,12,18,24,30,36 hours ]An area under the curve of serial levels of Troponin I and creatine kinase-MB isoenzyme during 36 hours
- Percentage of Participants With Periprocedural Myonecrosis [ Time Frame: 0,6,12,18,24,30,36 hours ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114995
|Principal Investigator:||Tae-Jin Youn, PhD||Seoul National University Bundang Hospital|