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Angiomax (Bivalirudin) - Summary

 
 



ANGIOMAX SUMMARY

Angiomax is a specific and reversible direct thrombin inhibitor. The active substance is a synthetic, 20 amino acid peptide.

Percutaneous Transluminal Coronary Angioplasty (PTCA)

Angiomax® (bivalirudin) is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).

Percutaneous Coronary Intervention (PCI)

Angiomax with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as listed in the REPLACE-2 trial [see Clinical Studies] is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).

Angiomax is indicated for patients with, or at risk of, heparin induced thrombocytopenia (HIT) or heparin induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing PCI.

Use with Aspirin

Angiomax in these indications is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin [see Dosage and Administration and Clinical Studies].

Limitation of Use

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


See all Angiomax indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Angiomax (Bivalirudin)

Study: Popular new anticoagulants drive increase in atrial fibrillation treatment
Source: Blood / Hematology News From Medical News Today [2015.07.23]
Warfarin therapy declining as use of new anticoagulants skyrocketsMore adults than ever are visiting their doctors' offices for a prescription to treat atrial fibrillation, according to a study...

Lower risk treatment for blood clots 'empowers' patients, improves care
Source: Blood / Hematology News From Medical News Today [2015.07.17]
Potentially fatal blood clots account for thousands of emergency room visits each year and often those patients are admitted to the hospital, treated with an injectable anticoagulant and monitored...

Benefit of extending anticoagulation therapy lost after discontinuation of therapy
Source: Blood / Hematology News From Medical News Today [2015.07.09]
Among patients with a first episode of pulmonary embolism (the obstruction of the pulmonary artery or a branch of it leading to the lungs by a blood clot) who received 6 months of anticoagulant...

more news >>

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.

more studies >>

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.

The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids [Recruiting]
Thrombosis is a significant medical complication in children with chronic diseases. The currently utilized treatments have many drawbacks which can lead to poor outcomes. More modern therapies are available but have not been systematically tested in children. This study will determine whether one such medication, bivalirudin is a safer and more effective alterative.

This study will monitor what effects the drug has upon the child's body and how the body processes the study drug (absorption, metabolism and elimination). The study will also evaluate the drug's effectiveness by following how long it takes to dissolve the clot. The safety issues being monitored relate to any observations of major or minor bleeding episodes after taking the drug, and/or any other side effects.

more trials >>

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 >>


Page last updated: 2015-07-23

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