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Aggrastat (Tirofiban Hydrochloride) - Summary

 
 



AGGRASTAT SUMMARY

AGGRASTAT (tirofiban hydrochloride), a non-peptide antagonist of the platelet glycoprotein (GP) llb/llla receptor, inhibits platelet aggregation.

AGGRASTAT, in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy. In this setting, AGGRASTAT has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure (for discussion of trial results and for definition of acute coronary syndrome see CLINICAL PHARMACOLOGY, Clinical Trials).

AGGRASTAT has been studied in a setting, as described in Clinical Trials, that included aspirin and heparin.


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NEWS HIGHLIGHTS

Media Articles Related to Aggrastat (Tirofiban)

ACS: What Works, What's Coming
Source: MedPage Today Emergency Medicine [2014.07.21]
(MedPage Today) -- The basic strategy for acute coronary syndrome might be well established, but questions still abound, leaders in cardiology said.

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Published Studies Related to Aggrastat (Tirofiban)

Net clinical benefit of prehospital glycoprotein IIb/IIIa inhibitors in patients with ST-elevation myocardial infarction and high risk of bleeding: effect of tirofiban in patients at high risk of bleeding using CRUSADE bleeding score. [2012]
(STEMI) patients with high risk of bleeding... CONCLUSION: Prehospital use of tirofiban in STEMI patients with high risk of

Tirofiban use with clopidogrel and aspirin decreases adverse cardiovascular events after percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis of randomized trials. [2011.09]
Current guidelines deemed usefulness of routine early glycoprotein IIb/IIIa inhibitor (GPI) administration in ST-elevation myocardial infarction (STEMI) before primary percutaneous coronary intervention (PCI) with dual antiplatelet therapy as uncertain...

Safety of Tirofiban in acute Ischemic Stroke: the SaTIS trial. [2011.09]
BACKGROUND AND PURPOSE: Tirofiban is a highly selective, fast-acting nonpeptide glycoprotein IIb/IIIa platelet receptor antagonist with a short half-life time. Glycoprotein IIb/IIIa antagonists are effective for the treatment of acute coronary syndromes proven in large clinical trials. Safety and efficacy in patients with ischemic stroke are uncertain. This was addressed in the Safety of Tirofiban in acute Ischemic Stroke (SaTIS) trial... CONCLUSIONS: We conclude that tirofiban might be safe in acute moderate ischemic stroke even when administered within a large time window after symptom onset and might save lives in the late outcome. Clinical Trial Registration- URL: www.strokecenter.org/trials/. Trial name: SaTIS. Enrollment began before July 1, 2005.

A randomized two-by-two comparison of high-dose bolus tirofiban versus abciximab and unfractionated heparin versus bivalirudin during percutaneous coronary revascularization and stent placement: the tirofiban evaluation of novel dosing versus abciximab with clopidogrel and inhibition of thrombin (TENACITY) study trial. [2011.06.01]
CONCLUSION: With limited assessment, this direct comparison of high-dose bolus tirofiban versus abciximab produced encouraging results and suggests that further study of this tirofiban dose regimen is warranted. The limited assessments comparing heparin and bivalirudin are consistent with prior observations. Copyright (c) 2010 Wiley-Liss, Inc.

Long-term reduction of mortality in the 4-year follow up of tirofiban therapy in elective percutaneous coronary interventions (TOPSTAR) trial. [2011.04]
BACKGROUND: TOPSTAR was a randomized, placebo-controlled trial studying the effects of adding the glycoprotein IIb/IIIa inhibitor tirofiban to conventional treatment with aspirin and clopidogrel in patients undergoing elective percutaneous coronary interventions (PCI). TOPSTAR demonstrated a lower periprocedural troponin release and a reduced 6-month mortality risk following PCI. The present study analyzed the corresponding long-term effects... CONCLUSIONS: The reduced 6-month mortality risk after elective PCI in the TOPSTAR trial persisted after 4 years of follow up. Even in this relatively small study, periprocedural effective platelet inhibition had a sustained impact on long-term mortality risk.

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Clinical Trials Related to Aggrastat (Tirofiban)

Pharmacokinetic Evaluation of Tirofiban Using a Single High-Dose Bolus In Subjects With Varying Degrees of Renal Function [Not yet recruiting]
The purpose of this study is to evaluate tirofiban concentration in the blood over a period of 24 hours after tirofiban administration. Subjects with varying degrees of renal insufficiency (i. e. kidney function) will be included in the study. Tirofiban is known to be cleared from the blood by the kidneys and so people with kidney problems clear tirofiban to a slower extent compared to people without kidney problems. By comparing the tirofiban concentration profile between subjects with healthy kidney function versus with impaired kidney function, a tirofiban dosing recommendation for subjects with impaired kidney function can be made.

This is a non-randomized, single-center, open-label study. A single dose of tirofiban (25 µg/kg administered intravenously over a 3 min period) will be administered to subjects with normal renal function (>90 mL/min CrCl), moderate (30-59 mL/min CrCl), and severe (<30 mL/min CrCl) renal impairment with non-dialysis-dependent renal insufficiency

Aggrastat Truncated Length Against Standard Therapies in Percutaneous Coronary Intervention [Not yet recruiting]
The purpose of this study is to determine whether the efficacy of tirofiban (a 25mcg/kg i. v. bolus followed by a 0. 15mcg/kg/min i. v. infusion during a percutaneous coronary intervention (PCI) plus two hours after the procedure) is more effective than placebo in the setting of standard therapies (e. g. aspirin, a thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as assessed by the incidence of adverse cardiac ischemic events defined as death, myocardial infarction (MI), and urgent target vessel revascularization (uTVR) within 48 hours following study drug initiation.

A secondary objective of this study is to assess whether tirofiban (a 25mcg/kg i. v. bolus followed by a 0. 15mcg/kg/min i. v. infusion during a PCI plus two hours after the procedure) is safe compared to placebo in the setting of standard therapies (e. g. aspirin, a thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as assessed by the incidence of non-CABG-related TIMI major bleeding within 48 hours following study drug initiation.

Patient enrollment is pending.

Safety of High-Dose Tirofiban During Coronary Angioplasty [Recruiting]
This single-centre study is intended to retrospectively check the safety of high-dose bolus of tirofiban in patients who underwent percutaneous angioplasty.

FATA: Randomized Study on Facilitated Angioplasty With Tirofiban or Abciximab [Completed]

The elective("standard of care") treatment of ST - elevation acute myocardial infarction

(STEMI) currently consists of primary angioplasty with stent implantation during administration of Abciximab, a inhibitor of GP IIb/IIIa platelet receptor.

Tirofiban is another potent inhibitor of GP IIb/IIIa platelet receptor with an efficacy on platelet aggregation inhibition equal to or greater than Abciximab if a high dose bolus is used, i. e. 25 microg/kg, (platelet aggregation inhibition > 90% 15 minutes after infusion). It can therefore be hypothesized that this drug can improve the results of primary angioplasty to the same extent as Abciximab.

The aim of this study is to compare the efficacy, in terms of myocardial reperfusion indices, of Abciximab and high dose of Tirofiban in primary angioplasty for STEMI, both in the case of treatment before transfer and of treatment in the catheterization laboratory during the procedure.

The reference hypothesis for the study objective is the equivalence or the non-inferiority of Tirofiban with respect to Abciximab.

Shortened Aggrastat� Versus Integrilin in Percutaneous Coronary Intervention [Recruiting]
The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a shortened infusion duration compared to label-dosing eptifibatide in patients undergoing percutaneous coronary intervention (PCI) is associated with a non-inferior composite rate of death, PCI-related myocardial infarction, urgent target vessel revascularization or in-hospital major bleeding within 48 hours following PCI or hospital discharge, whichever comes first.

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Page last updated: 2014-07-21

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