European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial (EUROMAX)

Multi-centre, Multi-national, Prospective, Randomised, Open-label, Comparison of Bivalirudin to Other Guideline Based Current Therapies (Excluding Bivalirudin)

To show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in participants with ST segment elevation acute coronary syndrome (STE-ACS), intended for a primary percutaneous coronary intervention (PCI) management strategy, presenting either via ambulance or to centers where PCI is not performed.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Bivalirudin; Drug: Heparin

Detailed Description

The purpose of the trial is to show that the early administration of bivalirudin improves 30-day outcomes when compared to the current standard of care in participants with STE-ACS, with an onset of symptoms of >20 minutes and <12 hours, intended for a primary PCI management strategy, presenting either via ambulance or to centers where PCI is not performed.

All participants are to receive treatment with aspirin (150-325 milligrams [mg] administered orally or 250-500 mg intravenously [IV]), followed by 75-100 milligrams/day (mg/day) for at least 1 year and a loading dose of an approved P2Y12 receptor blocker, such as clopidogrel, prasugrel, or ticagrelor, that was to be continued as per European Society of Cardiology guidelines (preferably for 1 year) in all participants.

The primary objectives of the trial are to show that, when compared with standard anti-thrombotic therapies other than bivalirudin (which includes treatment with unfractionated heparin [UFH] and optional glycoprotein IIb/IIIa inhibitor [GPI]) that at 30 days:

• Bivalirudin is superior to control at reducing a composite of death and non-coronary artery bypass graft (CABG)-related protocol major bleeding.

• Study Type: Interventional
• Enrollment (Actual): 2198
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria
    • Hanusch Krankenhaus
  • Wien, Austria
    • Magistratsabeilung 70, Wiener
  • Wien, Austria
    • Universitats-Klinik Fur
  • Wien, Austria
    • Wilhelminenspital MA 6 - BA 19
• Czech Republic
  • Ceske Budejovice, Czech Republic
    • Zdravotnicka Zachranna Sluzba
• Denmark
  • Aarhus, Denmark
    • Aarhus Universitetshospital
  • Copenhagen, Denmark
    • Rigshospitalet
  • Copenhagen, Denmark
    • Akutlaegebil Kobenhavn, Hc Andersens Boulevard 23
  • Hellerup, Denmark
    • Gentofte Hospital
  • Hillerod, Denmark
    • Akutlaegebil Nordsjaelland
  • Odense, Denmark
    • Odense Universitets Hospital
  • Odense, Denmark
    • Laegeambulancen Odense
• France
  • Aubervilliers, France
    • Hopital Europeen Paris La Roseraie
  • Bobigny, France
    • Hospital Avicenne, Pharmacie -Gestion Des Essais Cliniques
  • Bordeaux Cedex, France
    • CHU de Bordeaux - Hôpital Pellegrin
  • Bourg En Bresse, France
    • Clinique Convert
  • Bourg En Bresse, France
    • Centre Hospitalier Bourg En Bresse
  • Bourges, France
    • Ch Jacques Coeur
  • Caen, France
    • Hôpital Privé saint Martin
  • Caen, France
    • Centre Hospitalier Universitaire de Caen
  • Cedex, France
    • Service de Cardiologie
  • Chateauroux, France
    • Ch Chateauroux
  • Clermont Ferrand, France
    • Chu Clermont-Ferrand, Hopital
  • Clermont Ferrand, France
    • Samu-Smur Chu Clermont-Ferrand
  • Clichy, France
    • Hopital Beaujon
  • Corbeil Essonne, France
    • Ch Sud Francilien - Site Corbeil
  • Corbeil-Essonnes Cedex, France
    • Ch Sud Francilien - Site Corbeil, Pharmacie
  • Cornebarrieu, France
    • Capio - Clinique Des Cedres
  • Creteil, France
    • Hospital Henri Mondor, Pharmacie
  • Garches, France
    • Samu 92 Hauts De Seine
  • Grenoble, France
    • Clinique Les Eaux Claires Ghm
  • La Tronche, France
    • Chu A Michallon Grenoble
  • La Tronche, France
    • Samu Chu A Michallon Grenoble
  • Le Chesnay Cedex, France
    • Hopital Andre Mignot - Centre Hospitalier De Versailles
  • Lille, France
    • CHR Lille
  • Lille, France
    • Samu 59/Samu Du Nord
  • Longjumeau, France
    • Centre Hospitalier de Longjumeau
  • Lyon, France
    • Centre Hospitalier St Joseph St Luc
  • Massy, France
    • Institut Hospitalier Jacques Cartier
  • Montelimar, France
    • Centre Hospitalier de Montélimar
  • Montfermeil, France
    • Chi Le Raincy - Montfermeil Site De Montfermeil
  • Neuilly, France
    • Clinique Ambroise Paré
  • Paris, France
    • Hôpital Européen Georges Pompidou
  • Paris, France
    • Hopital Bichat Claude Bernard
  • Paris, France
    • Centre Hospitalier
  • Pau, France
    • Ch De Pau Hopital Francois Mitterand
  • Pau, France
    • Samu Ch De Pau
  • Pessac, France
    • Cardiologic Hospital - Coronary Care Unit, University of Bordeaux
  • Seine et Marne, France
    • Pole Smur, Samu 77 - Medecine
  • St Martin D Heres, France
    • Clinique Belledonne
  • Toulouse, France
    • Clinique Pasteur
  • Toulouse, France
    • CHU Toulouse - Hôpital Rangueil
  • Toulouse, France
    • Chu De Toulouse - Hopital Paule De Viguier
  • Toulouse, France
    • Polyclinique du Parc
  • Valence, France
    • Centre Hospitalier de Valence
  • Vienne, France
    • Centre Hospitalier De Vienne Centre Hospitalier Lucien Hussel
• Germany
  • Bad Nauheim, Germany
    • Kerckhoff Heart Center
  • Bad Nauheim, Germany
    • Rettungsdienst Wetteraukreis
  • Berlin, Germany
    • Charite Universitatsmedizin Berlin Campus Virchow-Klinikum
  • Berlin, Germany
    • Lutzowstrabe
  • Berlin, Germany
    • Sana Klinikum Lichtenberg Oskar Ziethen Krankenhaus, Fanningerstrasse 32
  • Berlin, Germany
    • Universitatsklinikum Benjamin Franklin, Hindenburgdamm 30
  • Bremen, Germany
    • Klinikum Links der Weser
  • Duisburg, Germany
    • Evangelisches Bethesda Johanniter
  • Duisburg, Germany
    • Feuerwehr Duisburg
  • Duisburg, Germany
    • Herzzentrum Duisburg, Klinik Fur Kardiologie And Angiologie
  • Duisburg, Germany
    • Klinikum Duisburg Ggmbh
  • Frankfurt, Germany
    • Klinikum der Johann Wolfgang Goethe Universitat
  • Hannover, Germany
    • Medizinische Hochschule Hannover, Carl Neuberg Str. 1
  • Ludwigshafen, Germany
    • Klinikum Ludwigshafen
  • Luneburg, Germany
    • Stadtisches Klinikum Luneburg, Bogelstr. 1
  • Wuppertal, Germany
    • Helios Klinik Der Universitat Witten Herdecke
• Italy
  • Bologna, Italy
    • Policlinico S.Orsola Malpighi
  • Bologna, Italy
    • Ospedale Maggiore
  • Bologna, Italy
    • Ospedle Di Bentivoglio
  • Perugia, Italy
    • Ospedale Di Assisi
  • Perugia, Italy
    • Ospedale Di Castiglione Del Lago
  • Perugia, Italy
    • Ospedale Di Todi
  • Perugia, Italy
    • Ospedale S.Maria Misericordia
  • Pesaro, Italy
    • Azienda Ospedaliera San Salvatore
  • Pesaro, Italy
    • Asur Marche- Zona 1 Pesaro
  • Pesaro, Italy
    • Emergency Rescue & Mobile Als Unit, Lanciarini Pub
• Netherlands
  • Amersfoort, Netherlands
    • Meander Medisch Centrum
  • Amersfoort, Netherlands
    • Betreft Research Regional
  • Amersfoort, Netherlands
    • Rav Noord En Oost Gelderland
  • Nieuwegein, Netherlands
    • St Antonius Ziekenhuis
  • Nieuwegein, Netherlands
    • Pharmacy Department
  • Nieuwegein, Netherlands
    • Regional Ambulance Service Gelderland Midden
  • Nijmegan, Netherlands
    • Service Gelderland-Zuid Klinisch Geneesmiddelonderzoek Klinsche Farmacie Afd Klinsche Farmacie
  • Nijmegen, Netherlands
    • Cwz Klinisch Geneesmiddelonderzoek Klinische
  • Nijmegen, Netherlands
    • Kgo Team Regional Ambulance
  • Nijmegen, Netherlands
    • Regional Ambulance Service Gelderland Zuid
  • Nijmegen, Netherlands
    • Regional Ambulance Service Gelderland-Zuid Distributiecentrum
  • Nijmegen, Netherlands
    • Regional Ambulance Service
  • Nijmegen, Netherlands
    • Umc St.Radboud Nijmegen
  • Utrecht, Netherlands
    • UMC Utrecht
  • Utrecht, Netherlands
    • Department of cardiology
  • Zwolle, Netherlands
    • Isala Klinieken
  • Zwolle, Netherlands
    • Tav Trial Team, Isala Klinieken Ioc Weezenlanden Afd
• Poland
  • Bedzin, Poland
    • Poradnia Kardiologiczna
  • Chrzanow, Poland
    • Malopolskie Centrum Sercowo
  • Chrzanow, Poland
    • Szpital Powiatowy W Chrzanowie
  • Dabrowa Gornicza, Poland
    • Oddzial Polskiej-Amerikanskiej Kliniki Serca
  • Debica, Poland
    • Szpital Powiatowy W Debicy
  • Gorlice, Poland
    • Specialist Hospital Gorlice
  • Kolbuszowa, Poland
    • Szpital Powiatowy Im. Jana Pawla Ii W Kolbuszowej
  • Krakow, Poland
    • Oddzial Kardiologii
  • Krakow, Poland
    • Jagiellonian University Medical College,
  • Krakow, Poland
    • Krakowskie Centrum
  • Krakow, Poland
    • Samodzielny Publiczny Zaklad Opieki
  • Krakow, Poland
    • Szpital Specjalistyczny Im Szpitalny Oddzial Ratunkowy
  • Krynica Zdroj, Poland
    • Spzoz Szpital Im. J.Dietla W Krynicy Zdroj
  • Lask, Poland
    • Spzoz Lask
  • Limanowa, Poland
    • Szpital Powiatowy W Limanowej
  • Lodz, Poland
    • Szpital Bieganskiego
  • Lublin, Poland
    • Medical University of Lublin
  • Mielec, Poland
    • Polsko-Amerykanskie Kliniki Serca, Szpital Powiatowy
  • Mielec, Poland
    • Samodzielny Pobliszny Zaklad W Mielcu
  • Myslowice, Poland
    • Myslowickie Centrum Zdrowia
  • Niepolomice, Poland
    • Samodzielna Publiczna Stacja Pogotowia Ratunkowego, Samodzielna Publiczna Stacja Pogotowia Ratunkowego W Niepolomicach
  • Nowy Sacz, Poland
    • Intercard Nowy Sacz
  • Olkusz, Poland
    • Nzoz Nowy Szpital W Olkuszu
  • Opatow, Poland
    • Szpital Powiatowy
  • Ostrowiec Swietokrzyski, Poland
    • Carint
  • Parczew, Poland
    • Spzoz Parczew
  • Piotrkow Trybunalski, Poland
    • Samodzielny Szpital Wojewodski
  • Radzyn Podlaski, Poland
    • Spzoz W Radzyniu Podlaskim
  • Sedziszow Malopolski, Poland
    • Szpital Powiatowy W Sedziszowie Malopolskim
  • Staszow, Poland
    • Oddzial Chorob Wewnetrznych
  • Swidnik, Poland
    • Oddzial Kardiologii Al.Lotnikow Polskich 18
  • Todz, Poland
    • Szpital Zakonu Bonifratrow Sw.
• Slovenia
  • Celje, Slovenia
    • Zdravstveni Dom Celje
  • Izola, Slovenia
    • Splosna Bolnisnica Izola, Polje 40
  • Jesenice, Slovenia
    • Oe Zdravstveni Dom Jesenice
  • Jesenice, Slovenia
    • Splosna Bolnisnica Jesenic
  • Lenart, Slovenia
    • Zdravstveni Dom Lenart, Maistrova 22
  • Ljubljana, Slovenia
    • Univerzitetni klinicni center Ljubljana
  • Ljubljana, Slovenia
    • Zdravstveni Dom Ljubljana
  • Maribor, Slovenia
    • Univerzitetni Klinicni Center Maribor
  • Maribor, Slovenia
    • Zdravstveni Dom Dr. Adolfa Drolca Maribor
  • Novo Mesto, Slovenia
    • Splosna Bolnisnica Novo Mesto/ Community Hospital Novo Mesto, Smihelska Cesta 1
  • Ormoz, Slovenia
    • Zdravstveni Dom Ormoz
  • Ptuj, Slovenia
    • Splosna Bolnisnica Ptuj, Interni Odelek, Potrceva Cesta 23
  • Slovenska Bistrica, Slovenia
    • Zdravstveni Dom Slovenska Bistrica
  • Slovenske Konjice, Slovenia
    • Zdravstveni Dom Slovenske Konjice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

The decision to randomize participants was made by a qualified physician or paramedic who was present at the time.

Participants were included in the study if they presented either via ambulance or to a center where PCI was not performed and met all of the following criteria:

1. Provided written informed consent before initiation of any study related procedures. Participants randomized in the ambulance may initially have signed an abridged version.
2. Aged ≥18 years at the time of randomization.

3. Had a presumed diagnosis of STE-ACS with onset of symptoms of >20 minutes and <12 hours with one or more of the following:

   • ST segment elevation of ≥1 millimeters (mm) in ≥2 contiguous leads
   • Presumably new left bundle branch block
   • An infero-lateral myocardial infarction with ST segment depression of ≥1 mm in ≥2 of leads V1-3 with a positive terminal T wave
4. All participants would proceed with emergent angiography and primary PCI if indicated <2 hours after first medical contact

Exclusion Criteria:

Participants were excluded from the study if any of the following exclusion criteria applied prior to randomization:

1. Any bleeding diathesis or severe hematological disease or history of intra-cerebral mass, aneurysm, arterio-venous malformation, hemorrhagic stroke, intra-cranial hemorrhage, or gastrointestinal or genitourinary bleeding within the last 2 weeks.
2. Participants who had undergone recent surgery (including biopsy) within the last 2 weeks.
3. Participants who were on warfarin (not applicable if International Normalized Ratio known to be <1.5).
4. Participants who had received UFH, LMWH, or bivalirudin immediately before randomization.
5. Thrombolytic therapy within the last 48 hours.
6. Absolute contra-indications or allergy that could not be pre-medicated to iodinated contrast or to any of the study medications including aspirin or clopidogrel.
7. Contraindications to angiography, including but not limited to severe peripheral vascular disease.
8. If it was known, pregnant or nursing mothers. Women of child-bearing age were asked if they were pregnant or thought that they may be pregnant.
9. If it is known, a creatinine clearance <30 milliliter/minute or dialysis dependent.
10. Previous enrolment in this study.
11. Treatment with other investigational drugs or devices within the 30 days preceding randomization or planned use of other investigational drugs or devices in this trial.
12. Participants may not have been enrolled if the duration of randomized investigational medicinal product anti-thrombin infusion was likely to be <30 minutes from the time of onset to the commencement of angiography.
13. Participants may not have been enrolled within a primary PCI-capable hospital (unless at the time of randomization, the catheter laboratory was not available, and the participant required transfer to another primary PCI capable hospital).
14. Estimated body weight of >120 kg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bivalirudin; Given immediately upon enrollment as an intravenous (IV) bolus of 0.75 mg/kilogram (mg/kg), followed immediately by an infusion of 1.75 mg/kg/hour (mg/kg/h). This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.	Drug: Bivalirudin; Other Names: Angiomax; Angiox
ACTIVE_COMPARATOR: Standard of Care: Heparins with Optional GPI; Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international units/kg [IU/kg] without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-micrograms/kilogram [μg/kg] IV boluses with a 10-minute [min] interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]). For this study, the control consisted of treatment with UFH or low molecular weight heparin (LMWH) with or without GPI and is referred to as "heparins with optional GPI."	Drug: Heparin; Other Names: LMWH; UFH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding	A participant was defined to have had a composite event if the participant experienced at least 1 of the 2 components (death or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any 1 of the following: intra-cranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in hemoglobin (Hb) concentration of >4 grams/deciliter (g/dL) without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding; re-intervention for bleeding, or use of any blood product transfusion.	Within 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding	A participant had a composite event if the participant experienced at least 1 of the 3 components (death, re-infarction [MI], or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of >4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. MI was defined as a positive diagnosis of re-infarction (new event) not associated with index PCI.	Within 30 days
The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR)	Incidence=number of participants to experience the event/total number of at risk participants x 100. Death from any cause at any time. Re-infarction was a positive diagnosis of re-infarction not associated with index PCI. Non-CABG major bleeding was any 1 of: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of >4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. IDR was any refractory ischemia-driven repeat percutaneous intervention or bypass graft surgery involving any native coronary or pre-existing bypass graft vessel. In the absence of pain, new ST segment changes indicative of ischemia, acute pulmonary edema, ventricular arrhythmias, or hemodynamic instability presumed to be ischemic in origin, will constitute sufficient evidence of ischemia.	Within 30 days
The Incidence of Death at 1 Year	Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time.	Within 1 Year
The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO)	Incidence=the number of participants to experience the event/total number of at risk participants x 100. Major bleeding based on TIMI criteria was defined as any intra-cranial bleeding, or any bleeding associated with clinically overt signs associated with a drop in Hb of >5 g/dL (or, when Hb was not available, an absolute drop in hematocrit [Hct] >15%). Major bleeding based on GUSTO criteria was defined as severe/life-threatening: intra-cranial hemorrhage or resulting in substantial hemodynamic compromise requiring treatment.	Within 30 days
The Incidence of Minor Bleeding: TIMI and GUSTO	Incidence=the number of participants to experience the event/total number of at risk participants x 100. Minor bleeding based on TIMI criteria was defined as any clinically overt sign of bleeding (including observation by imaging techniques) that was associated with a fall in Hb of ≥3 g/dL and ≤5 g/dL (or, when Hb was not available, an absolute drop in Hct of ≥9% and ≤15%). Minor bleeding based on GUSTO criteria was defined as other bleed not requiring blood transfusion or causing hemodynamic compromise.	Within 30 days
The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition])	Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stent thrombosis, based on the ARC definition, was defined as angiographic confirmation of stent thrombosis, non-occlusive thrombus, occlusive thrombus, or pathological confirmation of stent thrombosis.	Within 30 days
The Incidence of Thrombocytopenia	Incidence=the number of participants to experience the event/total number of at risk participants x 100. Thrombocytopenia was defined as a post-procedural platelet count <100,000 cells/millimeter cubed (cells/mm^3) in a participant with a baseline or pre-procedural platelet count >100,000 cells/mm^3.	Within 30 days
The Incidence of Stroke	Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stroke was defined as a sudden, focal neurological defect resulting from a cerebrovascular cause, resulting in death or lasting greater than 24 hours that was not due to a readily identifiable cause, such as a tumor, infection, or trauma.	Within 30 days

Collaborators and Investigators

• Sponsor: The Medicines Company
• Investigators: Study Chair: Gabriel Steg, Prof, Executive Committee; Study Chair: Christian Hamm, BSc, MD, PhD, International Steering Committee

Publications and helpful links

General Publications

• Huber K, Ducrocq G, Hamm CW, van 't Hof A, Lapostolle F, Coste P, Gordini G, Steinmetz J, Verheugt FWA, Adgey J, Nibbe L, Kanic V, Clemmensen P, Zeymer U, Bernstein D, Prats J, Deliargyris EN, Gabriel Steg P. Early clinical outcomes as a function of use of newer oral P2Y12 inhibitors versus clopidogrel in the EUROMAX trial. Open Heart. 2017 Nov 28;4(2):e000677. doi: 10.1136/openhrt-2017-000677. eCollection 2017.
• Fabris E, Kilic S, Van't Hof AWJ, Ten Berg J, Ayesta A, Zeymer U, Hamon M, Soulat L, Bernstein D, Anthopoulos P, Deliargyris EN, Steg PG. One-Year Mortality for Bivalirudin vs Heparins Plus Optional Glycoprotein IIb/IIIa Inhibitor Treatment Started in the Ambulance for ST-Segment Elevation Myocardial Infarction: A Secondary Analysis of the EUROMAX Randomized Clinical Trial. JAMA Cardiol. 2017 Jul 1;2(7):791-796. doi: 10.1001/jamacardio.2016.5975.
• Ducrocq G, Steg PG, Van't Hof A, Zeymer U, Mehran R, Hamm CW, Bernstein D, Prats J, Deliargyris EN, Stone GW. Utility of post-procedural anticoagulation after primary PCI for STEMI: insights from a pooled analysis of the HORIZONS-AMI and EUROMAX trials. Eur Heart J Acute Cardiovasc Care. 2017 Oct;6(7):659-665. doi: 10.1177/2048872616650869. Epub 2016 Jun 10.
• Dangas GD, Schoos MM, Steg PG, Mehran R, Clemmensen P, van 't Hof A, Prats J, Bernstein D, Deliargyris EN, Stone GW. Early Stent Thrombosis and Mortality After Primary Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Patient-Level Analysis of 2 Randomized Trials. Circ Cardiovasc Interv. 2016 May;9(5):e003272. doi: 10.1161/CIRCINTERVENTIONS.115.003272.
• Kilic S, Van't Hof AW, Ten Berg J, Lopez AA, Zeymer U, Hamon M, Soulat L, Bernstein D, Deliargyris EN, Steg PG. Frequency and prognostic significance of access site and non-access site bleeding and impact of choice of antithrombin therapy in patients undergoing primary percutaneous coronary intervention. The EUROMAX trial. Int J Cardiol. 2016 May 15;211:119-23. doi: 10.1016/j.ijcard.2016.02.131. Epub 2016 Mar 3.
• Hamon M, Coste P, Van't Hof A, Ten Berg J, Clemmensen P, Tabone X, Benamer H, Kristensen SD, Cavallini C, Marzocchi A, Hamm C, Kanic V, Bernstein D, Anthopoulos P, Deliargyris EN, Steg PG. Impact of arterial access site on outcomes after primary percutaneous coronary intervention: prespecified subgroup analysis from the EUROMAX trial. Circ Cardiovasc Interv. 2015 Jun;8(6):e002049. doi: 10.1161/CIRCINTERVENTIONS.114.002049.
• Stone GW, Mehran R, Goldstein P, Witzenbichler B, Van't Hof A, Guagliumi G, Hamm CW, Genereux P, Clemmensen P, Pocock SJ, Gersh BJ, Bernstein D, Deliargyris EN, Steg PG. Bivalirudin versus heparin with or without glycoprotein IIb/IIIa inhibitors in patients with STEMI undergoing primary percutaneous coronary intervention: pooled patient-level analysis from the HORIZONS-AMI and EUROMAX trials. J Am Coll Cardiol. 2015 Jan 6;65(1):27-38. doi: 10.1016/j.jacc.2014.10.029.
• Steg PG, van 't Hof A, Clemmensen P, Lapostolle F, Dudek D, Hamon M, Cavallini C, Gordini G, Huber K, Coste P, Thicoipe M, Nibbe L, Steinmetz J, Ten Berg J, Eggink GJ, Zeymer U, Campo dell' Orto M, Kanic V, Deliargyris EN, Day J, Schuette D, Hamm CW, Goldstein P. Design and methods of European Ambulance Acute Coronary Syndrome Angiography Trial (EUROMAX): an international randomized open-label ambulance trial of bivalirudin versus standard-of-care anticoagulation in patients with acute ST-segment-elevation myocardial infarction transferred for primary percutaneous coronary intervention. Am Heart J. 2013 Dec;166(6):960-967.e6. doi: 10.1016/j.ahj.2013.08.025. Epub 2013 Nov 7.
• Steg PG, van 't Hof A, Hamm CW, Clemmensen P, Lapostolle F, Coste P, Ten Berg J, Van Grunsven P, Eggink GJ, Nibbe L, Zeymer U, Campo dell' Orto M, Nef H, Steinmetz J, Soulat L, Huber K, Deliargyris EN, Bernstein D, Schuette D, Prats J, Clayton T, Pocock S, Hamon M, Goldstein P; EUROMAX Investigators. Bivalirudin started during emergency transport for primary PCI. N Engl J Med. 2013 Dec 5;369(23):2207-17. doi: 10.1056/NEJMoa1311096. Epub 2013 Oct 30.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: March 12, 2010
• First Submitted That Met QC Criteria: March 15, 2010
• First Posted (ESTIMATE): March 16, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 12, 2016
• Last Update Submitted That Met QC Criteria: January 13, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: PCI; STEMI; UFH; bivalirudin; STE-ACS; EUROMAX; ambulance study; STE-MI participants
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Heparin; Bivalirudin
• Other Study ID Numbers: TMC-BIV-08-03