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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bivalirudin
Heparin
Sponsored by
The Medicines Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring EUROMAX, STEMI, STE-ACS, UFH, bivalirudin, PCI, ambulance study, STE-MI participants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hanusch Krankenhaus
  • Magistratsabeilung 70, Wiener
  • Universitats-Klinik Fur
  • Wilhelminenspital MA 6 - BA 19
  • Zdravotnicka Zachranna Sluzba
  • Aarhus Universitetshospital
  • Akutlaegebil Kobenhavn, Hc Andersens Boulevard 23
  • Rigshospitalet
  • Gentofte Hospital
  • Akutlaegebil Nordsjaelland
  • Laegeambulancen Odense
  • Odense Universitets Hospital
  • Hopital Europeen Paris La Roseraie
  • Hospital Avicenne, Pharmacie -Gestion Des Essais Cliniques
  • Chu De Bordeaux - Hopital Pellegrin
  • Centre Hospitalier Bourg En Bresse
  • Clinique Convert
  • Ch Jacques Coeur
  • Centre Hospitalier Universitaire De Caen
  • Hopital Prive Saint Martin
  • Service De Cardiologie
  • Ch Chateauroux
  • Chu Clermont-Ferrand, Hopital
  • Samu-Smur Chu Clermont-Ferrand
  • Hopital Beaujon
  • Ch Sud Francilien - Site Corbeil
  • Ch Sud Francilien - Site Corbeil, Pharmacie
  • Capio - Clinique Des Cedres
  • Hospital Henri Mondor, Pharmacie
  • Samu 92 Hauts De Seine
  • Clinique Les Eaux Claires Ghm
  • Chu A Michallon Grenoble
  • Samu Chu A Michallon Grenoble
  • Hopital Andre Mignot - Centre Hospitalier De Versailles
  • Chr Lille
  • Samu 59/Samu Du Nord
  • Centre Hospitalier De Longjumeau
  • Centre Hospitalier St Joseph St Luc
  • Institut Hospitalier Jacques Cartier
  • Centre Hospitalier De Montelimar
  • Chi Le Raincy - Montfermeil Site De Montfermeil
  • Clinique Ambroise Pare
  • Centre Hospitalier
  • Hopital Bichat Claude Bernard
  • Hopital Europeen Georges Pompidou
  • Ch De Pau Hopital Francois Mitterand
  • Samu Ch De Pau
  • Cardiologic Hospital - Coronary Care Unit, University of Bordeaux
  • Pole Smur, Samu 77 - Medecine
  • Clinique Belledonne
  • Chu De Toulouse - Hopital Paule De Viguier
  • Chu Toulouse - Hopital Rangueil
  • Clinique Pasteur
  • Polyclinique Du Parc
  • Centre Hospitalier De Valence
  • Centre Hospitalier De Vienne Centre Hospitalier Lucien Hussel
  • Kerckhoff Heart Center
  • Rettungsdienst Wetteraukreis
  • Charite Universitatsmedizin Berlin Campus Virchow-Klinikum
  • Lutzowstrabe
  • Sana Klinikum Lichtenberg Oskar Ziethen Krankenhaus, Fanningerstrasse 32
  • Universitatsklinikum Benjamin Franklin, Hindenburgdamm 30
  • Klinikum Links Der Weser
  • Evangelisches Bethesda Johanniter
  • Feuerwehr Duisburg
  • Herzzentrum Duisburg, Klinik Fur Kardiologie And Angiologie
  • Klinikum Duisburg Ggmbh
  • Klinikum Der Johann Wolfgang Goethe Universitat
  • Medizinische Hochschule Hannover, Carl Neuberg Str. 1
  • Klinikum Ludwigshafen
  • Stadtisches Klinikum Luneburg, Bogelstr. 1
  • Helios Klinik Der Universitat Witten Herdecke
  • Ospedale Maggiore
  • Ospedle Di Bentivoglio
  • Policlinico S.Orsola Malpighi
  • Ospedale Di Assisi
  • Ospedale Di Castiglione Del Lago
  • Ospedale Di Todi
  • Ospedale S.Maria Misericordia
  • Asur Marche- Zona 1 Pesaro
  • Azienda Ospedaliera San Salvatore
  • Emergency Rescue & Mobile Als Unit, Lanciarini Pub
  • Betreft Research Regional
  • Meander Medisch Centrum
  • Rav Noord En Oost Gelderland
  • Pharmacy Department
  • Regional Ambulance Service Gelderland Midden
  • St Antonius Ziekenhuis
  • Service Gelderland-Zuid Klinisch Geneesmiddelonderzoek Klinsche Farmacie Afd Klinsche Farmacie
  • Cwz Klinisch Geneesmiddelonderzoek Klinische
  • Kgo Team Regional Ambulance
  • Regional Ambulance Service Gelderland Zuid
  • Regional Ambulance Service Gelderland-Zuid Distributiecentrum
  • Regional Ambulance Service
  • Umc St.Radboud Nijmegen
  • Department Of Cardiology
  • Umc Utrecht
  • Isala Klinieken
  • Tav Trial Team, Isala Klinieken Ioc Weezenlanden Afd
  • Poradnia Kardiologiczna
  • Malopolskie Centrum Sercowo
  • Szpital Powiatowy W Chrzanowie
  • Oddzial Polskiej-Amerikanskiej Kliniki Serca
  • Szpital Powiatowy W Debicy
  • Specialist Hospital Gorlice
  • Szpital Powiatowy Im. Jana Pawla Ii W Kolbuszowej
  • Jagiellonian University Medical College,
  • Krakowskie Centrum
  • Oddzial Kardiologii
  • Samodzielny Publiczny Zaklad Opieki
  • Szpital Specjalistyczny Im Szpitalny Oddzial Ratunkowy
  • Spzoz Szpital Im. J.Dietla W Krynicy Zdroj
  • Spzoz Lask
  • Szpital Powiatowy W Limanowej
  • Szpital Bieganskiego
  • Medical University Of Lublin
  • Polsko-Amerykanskie Kliniki Serca, Szpital Powiatowy
  • Samodzielny Pobliszny Zaklad W Mielcu
  • Myslowickie Centrum Zdrowia
  • Samodzielna Publiczna Stacja Pogotowia Ratunkowego, Samodzielna Publiczna Stacja Pogotowia Ratunkowego W Niepolomicach
  • Intercard Nowy Sacz
  • Nzoz Nowy Szpital W Olkuszu
  • Szpital Powiatowy
  • Carint
  • Spzoz Parczew
  • Samodzielny Szpital Wojewodski
  • Spzoz W Radzyniu Podlaskim
  • Szpital Powiatowy W Sedziszowie Malopolskim
  • Oddzial Chorob Wewnetrznych
  • Oddzial Kardiologii Al.Lotnikow Polskich 18
  • Szpital Zakonu Bonifratrow Sw.
  • Zdravstveni Dom Celje
  • Splosna Bolnisnica Izola, Polje 40
  • Oe Zdravstveni Dom Jesenice
  • Splosna Bolnisnica Jesenic
  • Zdravstveni Dom Lenart, Maistrova 22
  • Univerzitetni Klinicni Center Ljubljana
  • Zdravstveni Dom Ljubljana
  • Univerzitetni Klinicni Center Maribor
  • Zdravstveni Dom Dr. Adolfa Drolca Maribor
  • Splosna Bolnisnica Novo Mesto/ Community Hospital Novo Mesto, Smihelska Cesta 1
  • Zdravstveni Dom Ormoz
  • Splosna Bolnisnica Ptuj, Interni Odelek, Potrceva Cesta 23
  • Zdravstveni Dom Slovenska Bistrica
  • Zdravstveni Dom Slovenske Konjice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bivalirudin

Standard of Care: Heparins with Optional GPI

Arm Description

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.

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."

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 12, 2010
Last Updated
January 13, 2016
Sponsor
The Medicines Company
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1. Study Identification

Unique Protocol Identification Number
NCT01087723
Brief Title
European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial
Acronym
EUROMAX
Official Title
Multi-centre, Multi-national, Prospective, Randomised, Open-label, Comparison of Bivalirudin to Other Guideline Based Current Therapies (Excluding Bivalirudin)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Medicines Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
EUROMAX, STEMI, STE-ACS, UFH, bivalirudin, PCI, ambulance study, STE-MI participants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bivalirudin
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care: Heparins with Optional GPI
Arm Type
Active Comparator
Arm Description
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."
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Other Intervention Name(s)
Angiox, Angiomax
Intervention Type
Drug
Intervention Name(s)
Heparin
Other Intervention Name(s)
UFH, LMWH
Primary Outcome Measure Information:
Title
The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding
Description
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.
Time Frame
Within 30 days
Secondary Outcome Measure Information:
Title
The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding
Description
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.
Time Frame
Within 30 days
Title
The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR)
Description
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.
Time Frame
Within 30 days
Title
The Incidence of Death at 1 Year
Description
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.
Time Frame
Within 1 Year
Title
The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO)
Description
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.
Time Frame
Within 30 days
Title
The Incidence of Minor Bleeding: TIMI and GUSTO
Description
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.
Time Frame
Within 30 days
Title
The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition])
Description
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.
Time Frame
Within 30 days
Title
The Incidence of Thrombocytopenia
Description
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.
Time Frame
Within 30 days
Title
The Incidence of Stroke
Description
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.
Time Frame
Within 30 days

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
29225903
Citation
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.
Results Reference
derived
PubMed Identifier
28273285
Citation
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.
Results Reference
derived
PubMed Identifier
27287251
Citation
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.
Results Reference
derived
PubMed Identifier
27165710
Citation
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.
Results Reference
derived
PubMed Identifier
26995053
Citation
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.
Results Reference
derived
PubMed Identifier
26056249
Citation
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.
Results Reference
derived
PubMed Identifier
25572507
Citation
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.
Results Reference
derived
PubMed Identifier
24268209
Citation
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.
Results Reference
derived
PubMed Identifier
24171490
Citation
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.
Results Reference
derived

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European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial

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