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AzTrials

Acute Coronary SyndromePhase 3EUROMAXNCT01087723

European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial

A Phase 3 study testing Bivalirudin and Heparin in people with Acute Coronary Syndrome, run by The Medicines Company at 145 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Bivalirudin and Heparin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,198 participants
Where
145 sitesin 9 countries
Study dates
Mar 2010to Aug 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • Participants were excluded from the study if any of the following exclusion criteria applied prior to randomization:
  • 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.
Show all 15Show fewer
  • 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

Trial locations and contacts

145 sites in 9 countries.

145 sites in 9 countries

France44 sites

  • Hopital Europeen Paris La Roseraie

    Aubervilliers

  • Hospital Avicenne, Pharmacie -Gestion Des Essais Cliniques

    Bobigny

  • Chu De Bordeaux - Hopital Pellegrin

    Bordeaux

  • Centre Hospitalier Bourg En Bresse

    Bourg-en-Bresse

  • Clinique Convert

    Bourg-en-Bresse

  • Ch Jacques Coeur

    Bourges

  • Centre Hospitalier Universitaire De Caen

    Caen

  • Hopital Prive Saint Martin

    Caen

  • Service De Cardiologie

    Cedex

  • Ch Chateauroux

    Châteauroux

  • Chu Clermont-Ferrand, Hopital

    Clermont-Ferrand

  • Samu-Smur Chu Clermont-Ferrand

    Clermont-Ferrand

  • Hopital Beaujon

    Clichy

  • Ch Sud Francilien - Site Corbeil

    Corbeil Essonne

  • Ch Sud Francilien - Site Corbeil, Pharmacie

    Corbeil-Essonnes

  • Capio - Clinique Des Cedres

    Cornebarrieu

  • Hospital Henri Mondor, Pharmacie

    Créteil

  • Samu 92 Hauts De Seine

    Garches

  • Clinique Les Eaux Claires Ghm

    Grenoble

  • Chu A Michallon Grenoble

    La Tronche

  • Samu Chu A Michallon Grenoble

    La Tronche

  • Hopital Andre Mignot - Centre Hospitalier De Versailles

    Le Chesnay

  • Chr Lille

    Lille

  • Samu 59/Samu Du Nord

    Lille

  • Centre Hospitalier De Longjumeau

    Longjumeau

  • Centre Hospitalier St Joseph St Luc

    Lyon

  • Institut Hospitalier Jacques Cartier

    Massy

  • Centre Hospitalier De Montelimar

    Montélimar

  • Chi Le Raincy - Montfermeil Site De Montfermeil

    Montfermeil

  • Clinique Ambroise Pare

    Neuilly

  • Centre Hospitalier

    Paris

  • Hopital Bichat Claude Bernard

    Paris

  • Hopital Europeen Georges Pompidou

    Paris

  • Ch De Pau Hopital Francois Mitterand

    Pau

  • Samu Ch De Pau

    Pau

  • Cardiologic Hospital - Coronary Care Unit, University of Bordeaux

    Pessac

  • Clinique Belledonne

    Saint-Martin-d'Hères

  • Pole Smur, Samu 77 - Medecine

    Seine Et Marne

  • Chu De Toulouse - Hopital Paule De Viguier

    Toulouse

  • Chu Toulouse - Hopital Rangueil

    Toulouse

  • Clinique Pasteur

    Toulouse

  • Polyclinique Du Parc

    Toulouse

  • Centre Hospitalier De Valence

    Valence

  • Centre Hospitalier De Vienne Centre Hospitalier Lucien Hussel

    Vienne

Other trials in France

Poland32 sites

  • Poradnia Kardiologiczna

    Będzin

  • Malopolskie Centrum Sercowo

    Chrzanów

  • Szpital Powiatowy W Chrzanowie

    Chrzanów

  • Oddzial Polskiej-Amerikanskiej Kliniki Serca

    Dąbrowa Górnicza

  • Szpital Powiatowy W Debicy

    Dębica

  • Specialist Hospital Gorlice

    Gorlice

  • Szpital Powiatowy Im. Jana Pawla Ii W Kolbuszowej

    Kolbuszowa

  • Jagiellonian University Medical College,

    Krakow

  • Krakowskie Centrum

    Krakow

  • Oddzial Kardiologii

    Krakow

  • Samodzielny Publiczny Zaklad Opieki

    Krakow

  • Szpital Specjalistyczny Im Szpitalny Oddzial Ratunkowy

    Krakow

  • Spzoz Szpital Im. J.Dietla W Krynicy Zdroj

    Krynica-Zdrój

  • Spzoz Lask

    Łask

  • Szpital Powiatowy W Limanowej

    Limanowa

  • Szpital Bieganskiego

    Lodz

  • Medical University Of Lublin

    Lublin

  • Polsko-Amerykanskie Kliniki Serca, Szpital Powiatowy

    Mielec

  • Samodzielny Pobliszny Zaklad W Mielcu

    Mielec

  • Myslowickie Centrum Zdrowia

    Mysłowice

  • Samodzielna Publiczna Stacja Pogotowia Ratunkowego, Samodzielna Publiczna Stacja Pogotowia Ratunkowego W Niepolomicach

    Niepołomice

  • Intercard Nowy Sacz

    Nowy Sącz

  • Nzoz Nowy Szpital W Olkuszu

    Olkusz

  • Szpital Powiatowy

    Opatów

  • Carint

    Ostrowiec Świętokrzyski

  • Spzoz Parczew

    Parczew

  • Samodzielny Szpital Wojewodski

    Piotrkow Trybunalski

  • Spzoz W Radzyniu Podlaskim

    Radzyń Podlaski

  • Szpital Powiatowy W Sedziszowie Malopolskim

    Sędziszów Małopolski

  • Oddzial Chorob Wewnetrznych

    Staszów

  • Oddzial Kardiologii Al.Lotnikow Polskich 18

    Świdnik

  • Szpital Zakonu Bonifratrow Sw.

    Todz

Other trials in Poland

Netherlands17 sites

  • Betreft Research Regional

    Amersfoort

  • Meander Medisch Centrum

    Amersfoort

  • Rav Noord En Oost Gelderland

    Amersfoort

  • Pharmacy Department

    Nieuwegein

  • Regional Ambulance Service Gelderland Midden

    Nieuwegein

  • St Antonius Ziekenhuis

    Nieuwegein

  • Service Gelderland-Zuid Klinisch Geneesmiddelonderzoek Klinsche Farmacie Afd Klinsche Farmacie

    Nijmegan

  • Cwz Klinisch Geneesmiddelonderzoek Klinische

    Nijmegen

  • Kgo Team Regional Ambulance

    Nijmegen

  • Regional Ambulance Service Gelderland Zuid

    Nijmegen

  • Regional Ambulance Service Gelderland-Zuid Distributiecentrum

    Nijmegen

  • Regional Ambulance Service

    Nijmegen

  • Umc St.Radboud Nijmegen

    Nijmegen

  • Department Of Cardiology

    Utrecht

  • Umc Utrecht

    Utrecht

  • Isala Klinieken

    Zwolle

  • Tav Trial Team, Isala Klinieken Ioc Weezenlanden Afd

    Zwolle

Other trials in Netherlands

Germany16 sites

  • Kerckhoff Heart Center

    Bad Nauheim

  • Rettungsdienst Wetteraukreis

    Bad Nauheim

  • Charite Universitatsmedizin Berlin Campus Virchow-Klinikum

    Berlin

  • Lutzowstrabe

    Berlin

  • Sana Klinikum Lichtenberg Oskar Ziethen Krankenhaus, Fanningerstrasse 32

    Berlin

  • Universitatsklinikum Benjamin Franklin, Hindenburgdamm 30

    Berlin

  • Klinikum Links Der Weser

    Bremen

  • Evangelisches Bethesda Johanniter

    Duisburg

  • Feuerwehr Duisburg

    Duisburg

  • Herzzentrum Duisburg, Klinik Fur Kardiologie And Angiologie

    Duisburg

  • Klinikum Duisburg Ggmbh

    Duisburg

  • Klinikum Der Johann Wolfgang Goethe Universitat

    Frankfurt

  • Medizinische Hochschule Hannover, Carl Neuberg Str. 1

    Hanover

  • Klinikum Ludwigshafen

    Ludwigshafen

  • Stadtisches Klinikum Luneburg, Bogelstr. 1

    Lüneburg

  • Helios Klinik Der Universitat Witten Herdecke

    Wuppertal

Other trials in Germany

Slovenia14 sites

  • Zdravstveni Dom Celje

    Celje

  • Splosna Bolnisnica Izola, Polje 40

    Izola

  • Oe Zdravstveni Dom Jesenice

    Jesenice

  • Splosna Bolnisnica Jesenic

    Jesenice

  • Zdravstveni Dom Lenart, Maistrova 22

    Lenart v Slovenskih Goricah

  • Univerzitetni Klinicni Center Ljubljana

    Ljubljana

  • Zdravstveni Dom Ljubljana

    Ljubljana

  • Univerzitetni Klinicni Center Maribor

    Maribor

  • Zdravstveni Dom Dr. Adolfa Drolca Maribor

    Maribor

  • Splosna Bolnisnica Novo Mesto/ Community Hospital Novo Mesto, Smihelska Cesta 1

    Novo Mesto

  • Zdravstveni Dom Ormoz

    Ormoz

  • Splosna Bolnisnica Ptuj, Interni Odelek, Potrceva Cesta 23

    Ptuj

  • Zdravstveni Dom Slovenska Bistrica

    Slovenska Bistrica

  • Zdravstveni Dom Slovenske Konjice

    Slovenske Konjice

Other trials in Slovenia

Italy10 sites

  • Ospedale Maggiore

    Bologna

  • Ospedle Di Bentivoglio

    Bologna

  • Policlinico S.Orsola Malpighi

    Bologna

  • Ospedale Di Assisi

    Perugia

  • Ospedale Di Castiglione Del Lago

    Perugia

  • Ospedale Di Todi

    Perugia

  • Ospedale S.Maria Misericordia

    Perugia

  • Asur Marche- Zona 1 Pesaro

    Pesaro

  • Azienda Ospedaliera San Salvatore

    Pesaro

  • Emergency Rescue & Mobile Als Unit, Lanciarini Pub

    Pesaro

Other trials in Italy

Denmark7 sites

  • Aarhus Universitetshospital

    Aarhus

  • Akutlaegebil Kobenhavn, Hc Andersens Boulevard 23

    Copenhagen

  • Rigshospitalet

    Copenhagen

  • Gentofte Hospital

    Hellerup

  • Akutlaegebil Nordsjaelland

    Hillerød

  • Laegeambulancen Odense

    Odense

  • Odense Universitets Hospital

    Odense

Other trials in Denmark

Austria4 sites

  • Hanusch Krankenhaus

    Vienna

  • Magistratsabeilung 70, Wiener

    Vienna

  • Universitats-Klinik Fur

    Vienna

  • Wilhelminenspital MA 6 - BA 19

    Vienna

Other trials in Austria

Czechia1 site

  • Zdravotnicka Zachranna Sluzba

    České Budějovice

Other trials in Czechia

About this study

Official title: 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.

Read the 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.
Being tested
Bivalirudin, Heparin
Keywords
EUROMAX, STEMI, STE-ACS, UFH, bivalirudin, PCI, ambulance study, STE-MI participants
Medical subject headings
Acute Coronary Syndrome, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BivalirudinDrug

    Also called Angiox, Angiomax

  • HeparinDrug

    Also called UFH, LMWH

Study groups in NCT01087723
Study groupRoleWhat they receive
BivalirudinExperimentalGiven 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.
Receives: Drug: Bivalirudin
Standard of Care: Heparins with Optional GPIActive 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."
Receives: Drug: Heparin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 30 days

Secondary outcomes (8)

  1. 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.

    Measured: Within 30 days

  2. 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.

    Measured: Within 30 days

  3. 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.

    Measured: Within 1 Year

  4. 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.

    Measured: Within 30 days

  5. 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.

    Measured: Within 30 days

  6. 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.

    Measured: Within 30 days

  7. 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.

    Measured: Within 30 days

  8. 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.

    Measured: Within 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionAug 2013
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01087723
Sponsor's protocol ID
TMC-BIV-08-03
Acronym
EUROMAX
Status last verified
Jan 2016
First submitted
12 Mar 2010
Last updated
12 Feb 2016
Data monitoring committee
Yes

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.

    PubMed 29225903

  • 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.

    PubMed 28273285

  • 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.

    PubMed 27287251

  • 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.

    PubMed 27165710

  • 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.

    PubMed 26995053

  • 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.

    PubMed 26056249

  • 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.

    PubMed 25572507

  • 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.

    PubMed 24268209

  • 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.

    PubMed 24171490

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bivalirudin and Heparin in people with Acute Coronary Syndrome, run by The Medicines Company at 145 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in France, Poland, Netherlands, Germany, Slovenia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding (time frame: Within 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01087723, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.

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