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)

Some Cases of Acute Coronary Syndrome Can Wait a Day (CME/CE)
Source: MedPage Today Emergency Medicine [2009.09.01]
For some patients with acute coronary syndrome, immediate invasive treatment did not improve outcomes more than waiting till the next day, a new study found.

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Published Studies Related to Aggrastat (Tirofiban)

Treatment of Progressive Stroke with Tirofiban - Experience in 35 Patients. [2009.09.08]
Background: In an open pilot study, we studied the safety and efficacy of treatment with the nonpeptide glycoprotein IIb/IIIa antagonist tirofiban in patients with progressive ischemic stroke...

Intensifying platelet inhibition with tirofiban in poor responders to aspirin, clopidogrel, or both agents undergoing elective coronary intervention: results from the double-blind, prospective, randomized Tailoring Treatment with Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel study. [2009.06.30]
CONCLUSIONS: In low-risk patients according to clinical presentation who had poor responsiveness to standard oral platelet inhibitors via a point-of-care assay, intensified platelet inhibition with tirofiban lowers the incidence of myocardial infarction after elective coronary intervention.

Benefit of standard versus low-dose tirofiban for percutaneous coronary intervention in very elderly patients with high-risk acute coronary syndrome. [2009.05]
AIM: This study aimed to compare the efficacy and safety between standard and low-dose tirofiban in the treatment of elderly high-risk non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients who underwent percutaneous coronary intervention (PCI)... CONCLUSION: In very elderly high-risk patients with NSTE-ACS undergoing PCI, low-dose tirofiban offered about the same level of protection from major ischemic events that standard doses did, with less associated bleeding.

Left ventricular function after ST-elevation myocardial infarction in patients treated with primary percutaneous coronary intervention and abciximab or tirofiban (from the Facilitated Angioplasty with Tirofiban or Abciximab [FATA] Trial). [2009.03.15]
Abciximab therapy during primary percutaneous coronary intervention (PCI) has shown to ameliorate left ventricular (LV) function recovery in patients with ST elevated myocardial infarction... Preprocedure Thrombolysis In Myocardial Infarction flow grade >0 seems to be the most important predictor of favorable LVEF and LV function recovery at 30 days.

Comparison of the effects of pretreatment with tirofiban, clopidogrel or both on the inhibition of platelet aggregation and activation in patients with acute coronary syndromes. [2009.01]
CONCLUSIONS: Tirofiban leads to greater early inhibition of platelet aggregation but less suppression of P-selectin expression than clopidogrel 600 mg. The addition of clopidogrel to tirofiban does not add any anti-aggregatory effect, but reduces P-selectin expression, thus likely adding a significant biological and clinical protective effect and providing a rationale for the combined use of the two drugs.

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Clinical Trials Related to Aggrastat (Tirofiban)

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.

Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI [Active, not recruiting]
The purpose of this study is to determine which from the four combinations tirofiban+sirolimus eluting stent (SES), tirofiban+bare metal stent (BMS), abciximab+SES, abciximab+BMS is the possible gold standard treatment for ST-segment elevation myocardial infarction in terms of efficacy and cost-efficacy.

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.

The GRACIA 3 Trial: Role of Paclitaxel Eluting Stent and Tirofiban With PCI in the Treatment of Acute ST- Segment Elevation Myocardial Infarction [Recruiting]
The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary angioplasty of the culprit artery with paclitaxel eluting stent significantly reduces the rate of restenosis in comparison with bare stents.

The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary stent-angioplasty of the culprit artery under the protection of tirofiban 120 minutes after fibrinolytic significantly improves epicardial and myocardial infusion in comparison with the strategy of performing immediate intravenous thrombolysis (tenecteplase plus enoxaparine) followed by coronary angiography and adequate revascularization.

Study of Tirofiban Administration in Patients With Aspirin and or Clopidogrel Resistance [Recruiting]
This study will evaluate whether adding tirofiban, administered at high bolus dose on top of aspirin and clopidogrel will lead to a lower rate of periprocedural myocardial infarction after percutaneous coronary intervention in elective patients presenting with aspirin and/or clopidogrel resistance.

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