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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bivalirudin | Experimental | 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: Heparins with Optional GPI | Active Comparator | 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." |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin | Drug |
|
| |
| Heparin |
| Measure | Description | Time Frame |
|---|---|---|
| The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding | A participant was defined to have had a composite event if the participant experienced at least 1 of the 2 components (death or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any 1 of the following: intra-cranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in hemoglobin (Hb) concentration of >4 grams/deciliter (g/dL) without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding; re-intervention for bleeding, or use of any blood product transfusion. | Within 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding | A participant had a composite event if the participant experienced at least 1 of the 3 components (death, re-infarction [MI], or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of >4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. MI was defined as a positive diagnosis of re-infarction (new event) not associated with index PCI. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel Steg, Prof | Executive Committee | Study Chair |
| Christian Hamm, BSc, MD, PhD | International Steering Committee | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanusch Krankenhaus | Vienna | Austria | ||||
| Magistratsabeilung 70, Wiener |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29225903 | Derived | 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. | |
| 28273285 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bivalirudin | Given immediately upon enrolment as an intravenous (IV) bolus of 0.75 milligrams/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 percutaneous coronary intervention (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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
|
| Within 30 days |
| The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR) | Incidence=number of participants to experience the event/total number of at risk participants x 100. Death from any cause at any time. Re-infarction was a positive diagnosis of re-infarction not associated with index PCI. Non-CABG major bleeding was any 1 of: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of >4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. IDR was any refractory ischemia-driven repeat percutaneous intervention or bypass graft surgery involving any native coronary or pre-existing bypass graft vessel. In the absence of pain, new ST segment changes indicative of ischemia, acute pulmonary edema, ventricular arrhythmias, or hemodynamic instability presumed to be ischemic in origin, will constitute sufficient evidence of ischemia. | Within 30 days |
| The Incidence of Death at 1 Year | Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. | Within 1 Year |
| The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO) | Incidence=the number of participants to experience the event/total number of at risk participants x 100. Major bleeding based on TIMI criteria was defined as any intra-cranial bleeding, or any bleeding associated with clinically overt signs associated with a drop in Hb of >5 g/dL (or, when Hb was not available, an absolute drop in hematocrit [Hct] >15%). Major bleeding based on GUSTO criteria was defined as severe/life-threatening: intra-cranial hemorrhage or resulting in substantial hemodynamic compromise requiring treatment. | Within 30 days |
| The Incidence of Minor Bleeding: TIMI and GUSTO | Incidence=the number of participants to experience the event/total number of at risk participants x 100. Minor bleeding based on TIMI criteria was defined as any clinically overt sign of bleeding (including observation by imaging techniques) that was associated with a fall in Hb of ≥3 g/dL and ≤5 g/dL (or, when Hb was not available, an absolute drop in Hct of ≥9% and ≤15%). Minor bleeding based on GUSTO criteria was defined as other bleed not requiring blood transfusion or causing hemodynamic compromise. | Within 30 days |
| The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition]) | Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stent thrombosis, based on the ARC definition, was defined as angiographic confirmation of stent thrombosis, non-occlusive thrombus, occlusive thrombus, or pathological confirmation of stent thrombosis. | Within 30 days |
| The Incidence of Thrombocytopenia | Incidence=the number of participants to experience the event/total number of at risk participants x 100. Thrombocytopenia was defined as a post-procedural platelet count <100,000 cells/millimeter cubed (cells/mm^3) in a participant with a baseline or pre-procedural platelet count >100,000 cells/mm^3. | Within 30 days |
| The Incidence of Stroke | Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stroke was defined as a sudden, focal neurological defect resulting from a cerebrovascular cause, resulting in death or lasting greater than 24 hours that was not due to a readily identifiable cause, such as a tumor, infection, or trauma. | Within 30 days |
| 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 Slovenskih 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 | Ormoz | 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 |
| Derived |
| 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. |
| 27287251 | Derived | 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. |
| 27165710 | Derived | 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. |
| 26995053 | Derived | 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. |
| 26056249 | Derived | 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. |
| 25572507 | Derived | 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. |
| 24268209 | Derived | 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. |
| 24171490 | Derived | 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. |
| FG001 | Standard of Care: Heparins With Optional GPI | Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of ST segment elevation acute coronary syndrome (STE-ACS ), not including bivalirudin: unfractionated heparin (UFH) (100 international units/kg [IU/kg] without glycoprotein IIb/IIIa inhibitor [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." |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants who were randomized and signed an ICF; ITT population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bivalirudin | Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 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. |
| BG001 | Standard of Care: Heparins With Optional GPI | Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international 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-μg/kg IV boluses with a 10-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 LMWH with or without GPI and is referred to as "heparins with optional GPI." |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Medical history: Participant Has Diabetes | Number | participants |
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| Medical history: Participant Is a Current smoker (within past 30 days) | Number | participants |
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| Medical history: Participant Has Hypertension | Number | participants |
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| Medical history: Participant Has Hyperlipidemia | Participant has known hyperlipidemia or is on lipid-lowering drugs | Number | participants |
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| Medical history: Participant Has Had Previous myocardial infarction (MI) | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Participants who were randomized and signed an ICF; ITT population | Posted | Number | percentage of participants | Within 30 days |
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| Secondary | 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. | Participants who were randomized and signed an ICF; ITT population | Posted | Number | percentage of participants | Within 30 days |
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| Secondary | 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. | Participants who were randomized and signed an ICF; ITT population | Posted | Number | percentage of participants | Within 30 days |
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| Secondary | 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. | Participants who were randomized and signed an ICF; ITT population | Posted | Number | percentage of participants | Within 1 Year |
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| Secondary | 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. | Participants who were randomized and signed an ICF; ITT population | Posted | Number | percentage of participants | Within 30 days |
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| Secondary | 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. | Participants who were randomized and signed an ICF; ITT population | Posted | Number | percentage of participants | Within 30 days |
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| Secondary | 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. | Participants who were randomized and signed an ICF; ITT population | Posted | Number | percentage of participants | Within 30 days |
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| Secondary | 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. | Participants who were randomized and signed an ICF; ITT population | Posted | Number | percentage of participants | Within 30 days |
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| Secondary | 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. | Participants who were randomized and signed an ICF; ITT population | Posted | Number | percentage of participants | Within 30 days |
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From screening to Day 30
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bivalirudin | Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 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. | 145 | 1,099 | 134 | 1,099 | ||
| EG001 | Standard of Care: Heparins With Optional GPI | Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international 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-μg/kg IV boluses with a 10-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 LMWH with or without GPI and is referred to as "heparins with optional GPI." | 129 | 1,094 | 119 | 1,094 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular fibrillation | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Coronary artery dissection | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Intracardiac thrombus | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Coronary artery perforation | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Ventricular septal defect acquired | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Coronary no-reflow phenomenon | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Atrioventricular block | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Ventricular arrhythmia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Ventricle rupture | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Stress cardiomyopathy | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Sinus arrest | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Sick sinus syndrome | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Pulseless electrical activity | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Papillary muscle rupture | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Mitral valve incompetence | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Interventricular septum rupture | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Cardiac disorder | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Cardiac asthma | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Atrioventricular block second degree | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA (12.1) | Systematic Assessment |
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| Intestinal infarction | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Abdominal wall haemorrhage | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (12.1) | Systematic Assessment |
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| Multi-organ failure | General disorders | MedDRA (12.1) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (12.1) | Systematic Assessment |
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| Death | General disorders | MedDRA (12.1) | Systematic Assessment |
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| Sudden cardiac death | General disorders | MedDRA (12.1) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (12.1) | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA (12.1) | Systematic Assessment |
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| Cardiac death | General disorders | MedDRA (12.1) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Pneumonia staphylococcal | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Pneumonia haemophilus | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Clostridial infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Gastrointestinal injury | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
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| Arteriogram coronary | Investigations | MedDRA (12.1) | Systematic Assessment |
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| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
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| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
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| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
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| Abdominal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
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| Hypotonia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
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| Nephropathy toxic | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
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| Calculus urinary | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
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| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Aortic dissection | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
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| Aortic stenosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
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| Aortic aneurysm rupture | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
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| Reperfusion injury | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
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| Haemodynamic instability | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
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| Circulatory collapse | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular tachycardia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Health Science Center | The Medicines Company | 800-388-1183 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D006493 | Heparin |
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
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| Czech Republic |
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| Netherlands |
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| Denmark |
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| Poland |
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| Italy |
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| France |
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| Germany |
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| Slovenia |
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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 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-μg/kg IV boluses with a 10-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 LMWH with or without GPI and is referred to as "heparins with optional GPI." |
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| OG001 | Standard of Care: Heparins With Optional GPI | Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international 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-μg/kg IV boluses with a 10-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 LMWH with or without GPI and is referred to as "heparins with optional GPI." |
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