Angiomax (Bivalirudin) - Summary

ANGIOMAX SUMMARY

ANGIOMAX® (bivalirudin) is a specific and reversible direct thrombin inhibitor. The active substance is a synthetic, 20 amino acid peptide. The chemical name is D-phenylal-anyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl -glycyl-L-aspartyl-L-phenylalanyl-L-glutamyl-L-glutamyl-L-isoleucyl-L-prolyl- L-glutamyl-L-glutamyl-L-tyrosyl-L-leucine trifluoroacetate (salt) hydrate (Figure 1).

Angiomax is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin (see Clinical Trials and DOSAGE AND ADMINISTRATION).

The safety and effectiveness of Angiomax have not been established when used in conjunction with platelet inhibitors other than aspirin, such as glycoprotein IIb/IIIa inhibitors (see PRECAUTIONS, Drug Interactions).

The safety and effectiveness of Angiomax have not been established in patients with unstable angina who are not undergoing PTCA or in patients with other acute coronary syndromes.

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NEWS HIGHLIGHTS

Media Articles Related to Angiomax (Bivalirudin)

New Oral Anticoagulant Drugs: A Guide From European Society Of Cardiology
Source: Blood / Hematology News From Medical News Today [2013.04.30]
A practical guide on the use of the new oral anticoagulants (NOACs) has been produced by the European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC). A guide was needed to summarise existing information on different drugs, to answer clinical questions that fall outside what drug companies can legally answer, and to make distinctions between the different drugs...

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Published Studies Related to Angiomax (Bivalirudin)

The effect of bivalirudin on costs and outcomes of treatment of ST-segment elevation myocardial infarction. [2011.09]
BACKGROUND: Bivalirudin is commonly used during percutaneous coronary intervention (PCI) rather than unfractionated heparin. The higher cost of bivalirudin may be offset if it reduces costly bleeding complications and/or length of stay. We sought to assess the effect of using bivalirudin on the costs of care among patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI... CONCLUSIONS: Use of bivalirudin among patients with STEMI treated with PCI appears to reduce bleeding and overall costs. Copyright (c) 2011 Mosby, Inc. All rights reserved.

Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomised controlled trial. [2011.06.25]
BACKGROUND: Primary results of the HORIZONS-AMI trial have been previously reported. In this final report, we aimed to assess 3-year outcomes... INTERPRETATION: The effectiveness and safety of bivalirudin monotherapy and paclitaxel-eluting stenting are sustained at 3 years for patients with STEMI undergoing primary percutaneous coronary intervention. FUNDING: Boston Scientific and The Medicines Company. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

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.

Heparin versus bivalirudin for carotid artery stenting using proximal endovascular clamping for neuroprotection: results from a prospective randomized study. [2010.12]
BACKGROUND: General recommendations indicate that, during a carotid artery stenting (CAS), sufficient unfractionated heparin (UFH) has to be given to maintain the activated clotting time between 250 to 300 seconds. Bivalirudin use is able to reduce postprocedural bleedings in percutaneous interventions when compared with UFH. The study purpose was to evaluate, in a randomized study, the safety and efficacy of bivalirudin versus heparin during CAS, using proximal endovascular occlusion (PEO) as a distal protection device... CONCLUSIONS: The use of bivalirudin should be considered a safe and effective anticoagulation regimen during CAS, using PEO as a distal protection device. Bivalirudin use is associated with a reduced incidence of bleedings. Copyright (c) 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

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. [2010.11.08]
Background: In the absence of high-dose thienopyridines, placebo-controlled trials have demonstrated a reduction in ischemic events with intravenous glycoprotein IIb/IIIa antagonists during percutaneous coronary intervention (PCI)... The limited assessments comparing heparin and bivalirudin are consistent with prior observations.

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Clinical Trials Related to Angiomax (Bivalirudin)

Study Of Angiomax In Infants Under Six Months With Thrombosis [Completed]
The goals of this study are:

1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;

2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;

3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).

Antithrombotic Effects of Ticagrelor Versus Clopidogrel [Recruiting]
The purpose of this study is to determine whether treatment with ticagrelor (plus aspirin and bivalirudin) is more effective than treatment with clopidogrel (plus aspirin and bivalirudin).

Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes (ACS) [Completed]
The purpose of this study is to show that, when compared with heparin (enoxaparin or unfractionated heparin) and routine GPIIb/IIIa inhibition (either started upfront or at the time of percutaneous coronary intervention [PCI]; Arm A):

1. Bivalirudin with routine GPIIb/IIIa inhibition (either started upfront or at the time of PCI; Arm B) provides non-inferior or superior overall clinical outcomes and

2. Bivalirudin alone (Arm C) reduces clinically significant bleeding. An important secondary objective for this comparison is to show that bivalirudin is not inferior for ischemic complications.

Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention [Recruiting]
The objective of the study is to assess the safety and efficacy of Angiomax® (bivalirudin) versus unfractionated heparin (UFH) in patients presenting with stable angina or silent ischemia (positive stress test without chest pain) that undergo percutaneous coronary intervention (PCI).

The primary endpoint of the study will be major and minor bleeding events, defined by the REPLACE-2 trial definition, during the index hospitalization and up to 30 days post discharge.

Peri-Procedural Myocardial Infarction, Platelet Reactivity, Thrombin Generation, and Clot Strength: Differential Effects of Eptifibatide + Bivalirudin Versus Bivalirudin [Recruiting]
The purpose of this study is to compare levels of clot formation (platelet aggregation), markers of heart muscle damage, and inflammation in two groups undergoing percutaneous coronary stent implantation. The first group will be on a regimen of high-dose clopidogrel used in combination with bivalirudin plus eptifibatide, and the second group will be on a regimen of high-dose clopidogrel with bivalirudin alone. Clinical outcomes will be determined up to one year after enrollment.

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Reports of Suspected Angiomax (Bivalirudin) Side Effects

Thrombosis in Device (18),  OFF Label USE (10),  Coronary Artery Thrombosis (6),  Acute Myocardial Infarction (6),  Myocardial Infarction (6),  Haemorrhage (5),  Drug Ineffective (4),  Chest Pain (4),  Coronary Artery Occlusion (4),  Procedural Complication (4), more >>