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)
1 other identifier
interventional
2,198
9 countries
145
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2010
Typical duration for phase_3
145 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 12, 2010
CompletedFirst Posted
Study publicly available on registry
March 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
February 12, 2016
CompletedFebruary 12, 2016
January 1, 2016
3.4 years
March 12, 2010
January 13, 2016
January 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding
Within 30 days
The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR)
Within 30 days
The Incidence of Death at 1 Year
Within 1 Year
The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO)
Within 30 days
The Incidence of Minor Bleeding: TIMI and GUSTO
Within 30 days
- +3 more secondary outcomes
Study Arms (2)
Bivalirudin
EXPERIMENTALGiven 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.
Standard of Care: Heparins with Optional GPI
ACTIVE COMPARATORStandard-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."
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- Provided written informed consent before initiation of any study related procedures. Participants randomized in the ambulance may initially have signed an abridged version.
- Aged ≥18 years at the time of randomization.
- 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
- All participants would proceed with emergent angiography and primary PCI if indicated \<2 hours after first medical contact
You may not qualify if:
- 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.
- Participants who had undergone recent surgery (including biopsy) within the last 2 weeks.
- Participants who were on warfarin (not applicable if International Normalized Ratio known to be \<1.5).
- Participants who had received UFH, LMWH, or bivalirudin immediately before randomization.
- Thrombolytic therapy within the last 48 hours.
- 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.
- Contraindications to angiography, including but not limited to severe peripheral vascular disease.
- 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.
- If it is known, a creatinine clearance \<30 milliliter/minute or dialysis dependent.
- Previous enrolment in this study.
- 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.
- 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.
- 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).
- Estimated body weight of \>120 kg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (145)
Hanusch Krankenhaus
Vienna, Austria
Magistratsabeilung 70, Wiener
Vienna, Austria
Universitats-Klinik Fur
Vienna, Austria
Wilhelminenspital MA 6 - BA 19
Vienna, Austria
Zdravotnicka Zachranna Sluzba
České Budějovice, Czechia
Aarhus Universitetshospital
Aarhus, Denmark
Akutlaegebil Kobenhavn, Hc Andersens Boulevard 23
Copenhagen, Denmark
Rigshospitalet
Copenhagen, Denmark
Gentofte Hospital
Hellerup, Denmark
Akutlaegebil Nordsjaelland
Hillerød, Denmark
Laegeambulancen Odense
Odense, Denmark
Odense Universitets Hospital
Odense, Denmark
Hopital Europeen Paris La Roseraie
Aubervilliers, France
Hospital Avicenne, Pharmacie -Gestion Des Essais Cliniques
Bobigny, France
Chu De Bordeaux - Hopital Pellegrin
Bordeaux, France
Centre Hospitalier Bourg En Bresse
Bourg-en-Bresse, France
Clinique Convert
Bourg-en-Bresse, France
Ch Jacques Coeur
Bourges, France
Centre Hospitalier Universitaire De Caen
Caen, France
Hopital Prive Saint Martin
Caen, France
Service De Cardiologie
Cedex, France
Ch Chateauroux
Châteauroux, France
Chu Clermont-Ferrand, Hopital
Clermont-Ferrand, France
Samu-Smur Chu Clermont-Ferrand
Clermont-Ferrand, France
Hopital Beaujon
Clichy, France
Ch Sud Francilien - Site Corbeil
Corbeil Essonne, France
Ch Sud Francilien - Site Corbeil, Pharmacie
Corbeil-Essonnes, France
Capio - Clinique Des Cedres
Cornebarrieu, France
Hospital Henri Mondor, Pharmacie
Créteil, France
Samu 92 Hauts De Seine
Garches, France
Clinique Les Eaux Claires Ghm
Grenoble, France
Chu A Michallon Grenoble
La Tronche, France
Samu Chu A Michallon Grenoble
La Tronche, France
Hopital Andre Mignot - Centre Hospitalier De Versailles
Le Chesnay, France
Chr Lille
Lille, France
Samu 59/Samu Du Nord
Lille, France
Centre Hospitalier De Longjumeau
Longjumeau, France
Centre Hospitalier St Joseph St Luc
Lyon, France
Institut Hospitalier Jacques Cartier
Massy, France
Centre Hospitalier De Montelimar
Montélimar, France
Chi Le Raincy - Montfermeil Site De Montfermeil
Montfermeil, France
Clinique Ambroise Pare
Neuilly, France
Centre Hospitalier
Paris, France
Hopital Bichat Claude Bernard
Paris, France
Hopital Europeen Georges Pompidou
Paris, France
Ch De Pau Hopital Francois Mitterand
Pau, France
Samu Ch De Pau
Pau, France
Cardiologic Hospital - Coronary Care Unit, University of Bordeaux
Pessac, France
Clinique Belledonne
Saint-Martin-d'Hères, France
Pole Smur, Samu 77 - Medecine
Seine Et Marne, France
Chu De Toulouse - Hopital Paule De Viguier
Toulouse, France
Chu Toulouse - Hopital Rangueil
Toulouse, France
Clinique Pasteur
Toulouse, France
Polyclinique Du Parc
Toulouse, France
Centre Hospitalier De Valence
Valence, France
Centre Hospitalier De Vienne Centre Hospitalier Lucien Hussel
Vienne, France
Kerckhoff Heart Center
Bad Nauheim, Germany
Rettungsdienst Wetteraukreis
Bad Nauheim, 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
Berlin, Germany
Klinikum Links Der Weser
Bremen, Germany
Evangelisches Bethesda Johanniter
Duisburg, Germany
Feuerwehr Duisburg
Duisburg, Germany
Herzzentrum Duisburg, Klinik Fur Kardiologie And Angiologie
Duisburg, Germany
Klinikum Duisburg Ggmbh
Duisburg, Germany
Klinikum Der Johann Wolfgang Goethe Universitat
Frankfurt, Germany
Medizinische Hochschule Hannover, Carl Neuberg Str. 1
Hanover, Germany
Klinikum Ludwigshafen
Ludwigshafen, Germany
Stadtisches Klinikum Luneburg, Bogelstr. 1
Lüneburg, Germany
Helios Klinik Der Universitat Witten Herdecke
Wuppertal, Germany
Ospedale Maggiore
Bologna, Italy
Ospedle Di Bentivoglio
Bologna, Italy
Policlinico S.Orsola Malpighi
Bologna, Italy
Ospedale Di Assisi
Perugia, Italy
Ospedale Di Castiglione Del Lago
Perugia, Italy
Ospedale Di Todi
Perugia, Italy
Ospedale S.Maria Misericordia
Perugia, Italy
Asur Marche- Zona 1 Pesaro
Pesaro, Italy
Azienda Ospedaliera San Salvatore
Pesaro, Italy
Emergency Rescue & Mobile Als Unit, Lanciarini Pub
Pesaro, Italy
Betreft Research Regional
Amersfoort, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
Rav Noord En Oost Gelderland
Amersfoort, Netherlands
Pharmacy Department
Nieuwegein, Netherlands
Regional Ambulance Service Gelderland Midden
Nieuwegein, Netherlands
St Antonius Ziekenhuis
Nieuwegein, Netherlands
Service Gelderland-Zuid Klinisch Geneesmiddelonderzoek Klinsche Farmacie Afd Klinsche Farmacie
Nijmegan, 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
Nijmegen, Netherlands
Department Of Cardiology
Utrecht, Netherlands
Umc Utrecht
Utrecht, Netherlands
Isala Klinieken
Zwolle, Netherlands
Tav Trial Team, Isala Klinieken Ioc Weezenlanden Afd
Zwolle, Netherlands
Poradnia Kardiologiczna
Będzin, Poland
Malopolskie Centrum Sercowo
Chrzanów, Poland
Szpital Powiatowy W Chrzanowie
Chrzanów, Poland
Oddzial Polskiej-Amerikanskiej Kliniki Serca
Dąbrowa Górnicza, Poland
Szpital Powiatowy W Debicy
Dębica, Poland
Specialist Hospital Gorlice
Gorlice, Poland
Szpital Powiatowy Im. Jana Pawla Ii W Kolbuszowej
Kolbuszowa, Poland
Jagiellonian University Medical College,
Krakow, Poland
Krakowskie Centrum
Krakow, Poland
Oddzial Kardiologii
Krakow, Poland
Samodzielny Publiczny Zaklad Opieki
Krakow, Poland
Szpital Specjalistyczny Im Szpitalny Oddzial Ratunkowy
Krakow, Poland
Spzoz Szpital Im. J.Dietla W Krynicy Zdroj
Krynica-Zdrój, Poland
Szpital Powiatowy W Limanowej
Limanowa, Poland
Szpital Bieganskiego
Lodz, Poland
Medical University Of Lublin
Lublin, Poland
Polsko-Amerykanskie Kliniki Serca, Szpital Powiatowy
Mielec, Poland
Samodzielny Pobliszny Zaklad W Mielcu
Mielec, Poland
Myslowickie Centrum Zdrowia
Mysłowice, Poland
Samodzielna Publiczna Stacja Pogotowia Ratunkowego, Samodzielna Publiczna Stacja Pogotowia Ratunkowego W Niepolomicach
Niepołomice, Poland
Intercard Nowy Sacz
Nowy Sącz, Poland
Nzoz Nowy Szpital W Olkuszu
Olkusz, Poland
Szpital Powiatowy
Opatów, Poland
Carint
Ostrowiec Świętokrzyski, Poland
Spzoz Parczew
Parczew, Poland
Samodzielny Szpital Wojewodski
Piotrkow Trybunalski, Poland
Spzoz W Radzyniu Podlaskim
Radzyń Podlaski, Poland
Szpital Powiatowy W Sedziszowie Malopolskim
Sędziszów Małopolski, Poland
Oddzial Chorob Wewnetrznych
Staszów, Poland
Oddzial Kardiologii Al.Lotnikow Polskich 18
Świdnik, Poland
Szpital Zakonu Bonifratrow Sw.
Todz, Poland
Spzoz Lask
Łask, Poland
Zdravstveni Dom Celje
Celje, Slovenia
Splosna Bolnisnica Izola, Polje 40
Izola, Slovenia
Oe Zdravstveni Dom Jesenice
Jesenice, Slovenia
Splosna Bolnisnica Jesenic
Jesenice, Slovenia
Zdravstveni Dom Lenart, Maistrova 22
Lenart v Slov. Goricah, Slovenia
Univerzitetni Klinicni Center Ljubljana
Ljubljana, Slovenia
Zdravstveni Dom Ljubljana
Ljubljana, Slovenia
Univerzitetni Klinicni Center Maribor
Maribor, Slovenia
Zdravstveni Dom Dr. Adolfa Drolca Maribor
Maribor, Slovenia
Splosna Bolnisnica Novo Mesto/ Community Hospital Novo Mesto, Smihelska Cesta 1
Novo Mesto, Slovenia
Zdravstveni Dom Ormoz
Ormož, Slovenia
Splosna Bolnisnica Ptuj, Interni Odelek, Potrceva Cesta 23
Ptuj, Slovenia
Zdravstveni Dom Slovenska Bistrica
Slovenska Bistrica, Slovenia
Zdravstveni Dom Slovenske Konjice
Slovenske Konjice, Slovenia
Related Publications (9)
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.
PMID: 29225903DERIVEDFabris 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.
PMID: 28273285DERIVEDDucrocq 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.
PMID: 27287251DERIVEDDangas 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.
PMID: 27165710DERIVEDKilic 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.
PMID: 26995053DERIVEDHamon 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.
PMID: 26056249DERIVEDStone 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.
PMID: 25572507DERIVEDSteg 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.
PMID: 24268209DERIVEDSteg 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.
PMID: 24171490DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Health Science Center
- Organization
- The Medicines Company
Study Officials
- STUDY CHAIR
Gabriel Steg, Prof
Executive Committee
- STUDY CHAIR
Christian Hamm, BSc, MD, PhD
International Steering Committee
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2010
First Posted
March 16, 2010
Study Start
March 1, 2010
Primary Completion
August 1, 2013
Study Completion
August 1, 2014
Last Updated
February 12, 2016
Results First Posted
February 12, 2016
Record last verified: 2016-01