Abstract
Early invasive management and the use of combined antithrombotic therapies have decreased the risk of recurrent ischaemia in patients with acute coronary syndrome (ACS) but have also increased the bleeding risk. Transradial intervention (TRI) and bivalirudin infusion compared to transfemoral intervention (TFI) or unfractionated heparin (UFH) plus glycoprotein IIb/IIIa inhibitors (GPI) decrease bleeding complications in patients with ACS. To what extent, a bleeding preventive strategy incorporating at least one of these two treatment options translates into improved outcomes is a matter of debate. The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX study is a large-scale, multicenter, prospective, open-label trial, conducted at approximately 100 sites in Europe aiming to primarily assess whether TRI and bivalirudin infusion, as compared to TFI and UFH plus provisional GPI, decrease the 30-day incidence of death, myocardial infarction or stroke across the whole spectrum of ACS patients.
Trial registration:
ClinicalTrials.gov NCT01433627.
Publication types
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Acute Coronary Syndrome / blood
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Acute Coronary Syndrome / diagnosis
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Acute Coronary Syndrome / mortality
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Acute Coronary Syndrome / therapy*
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Anticoagulants / administration & dosage*
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Anticoagulants / adverse effects
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Antithrombins / administration & dosage*
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Antithrombins / adverse effects
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Clinical Protocols
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Drug Therapy, Combination
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Europe
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Femoral Artery*
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Hemorrhage / chemically induced
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Hemorrhage / mortality
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Hemorrhage / prevention & control*
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Heparin / administration & dosage
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Heparin / adverse effects
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Hirudins / administration & dosage
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Hirudins / adverse effects
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Humans
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Peptide Fragments / administration & dosage
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Peptide Fragments / adverse effects
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Percutaneous Coronary Intervention / adverse effects
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Percutaneous Coronary Intervention / methods*
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Percutaneous Coronary Intervention / mortality
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Platelet Aggregation Inhibitors / administration & dosage*
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Platelet Aggregation Inhibitors / adverse effects
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Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors
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Platelet Glycoprotein GPIIb-IIIa Complex / metabolism
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Prospective Studies
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Punctures
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Radial Artery*
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Recombinant Proteins / administration & dosage
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Recombinant Proteins / adverse effects
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Research Design*
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Risk Factors
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Time Factors
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Treatment Outcome
Substances
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Anticoagulants
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Antithrombins
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Hirudins
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Peptide Fragments
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Platelet Aggregation Inhibitors
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Platelet Glycoprotein GPIIb-IIIa Complex
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Recombinant Proteins
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Heparin
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bivalirudin
Associated data
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ClinicalTrials.gov/NCT01433627