Angiomax is a specific and reversible direct thrombin inhibitor. The active substance is a synthetic, 20┬áamino 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.
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.
Clinical Trials Related to Angiomax (Bivalirudin)
Antithrombotic Effects of Ticagrelor Versus Clopidogrel [Completed]
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
Novel Approaches in Preventing and Limiting Events III Trial (NAPLES III): Bivalirudin in High-risk Bleeding Patients [Completed]
Bleeding occurring during percutaneous coronary interventions (PCI has now emerged as one of
the most common complication of PCI and adversely affect in-hospital, short- and long-term
outcome. As bivalirudin proved its effectiveness in decreasing haemorrhagic events during
PCI, its administration may be advocated in subjects deemed at high risk of
bleeding. Objective of the present trial is to compare the safety and effectiveness of
procedural use of bivalirudin in comparison to unfractionated heparin (UFH) in patients
undergoing PCI deemed at high risk of procedural bleeding.
A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI [Terminated]
This study is designed to determine the efficacy of REG1 compared to bivalirudin in
preventing periprocedural ischemic complications and major bleeding in patients undergoing
PCI as a treatment for CAD. Bivalirudin has been studied in patients undergoing PCI in both
ACS (NSTEMI and unstable angina [UA]) and elective PCI. In comparison to UFH, bivalirudin
has shown similar rates of ischemic events while demonstrating a significant reduction in
bleeding and an improved net clinical benefit.
Evidence from previous studies indicates that pegnivacogin represents an extremely potent,
chemically unique anticoagulant that can be reversed by anivamersen across multiple
populations (refer to Section 1. 2.2). The question that still remains is whether Factor IX
(FIX) inhibition by pegnivacogin can result in fewer ischemic events than a previously
studied agent while active control with anivamersen can preserve the benefit of reduced
bleeding. The purpose of this study is to evaluate REG1 in an adequately powered definitive
study with an open-label, multi-center, active-controlled, randomized design to answer that
Angiomax« or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention [Terminated]
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
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
The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids [Completed]
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
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.
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),
Drug Ineffective (4),
Chest Pain (4),
Coronary Artery Occlusion (4),
Procedural Complication (4), more >>
Page last updated: 2011-12-09