Pexelizumab in Conjunction With Angioplasty in Acute Myocardial Infarction (APEX-AMI)

APEX-AMI - Pexelizumab in Conjunction With Angioplasty

In the setting of reperfusion therapy in an acute myocardial infarction using primary percutaneous intervention (PCI), the body's own inflammatory system involving the complement cascade may be harmful. This study will test the safety and efficacy of a novel complement inhibitor, pexelizumab to reduce mortality at 30 days.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Drug: Placebo infusion; Drug: Pexelizumab

• Study Type: Interventional
• Enrollment (Actual): 5745
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Canberra Hospital
  • New South Wales
    • Concord, New South Wales, Australia, 2137
      • Concord Hospital
    • Gosford, New South Wales, Australia, 2250
      • Gosford Hospital
    • Kogarah, New South Wales, Australia, 2217
      • St. George Hospital
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Hospital
    • St. Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • Prince Charles Hospital
    • Douglas, Queensland, Australia, 4814
      • Townsville Hospital
    • Wooloong Abba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Box Hill, Victoria, Australia, 3084
      • Austin Hospital
    • Clayton, Victoria, Australia, 3162
      • Monash Medical Centre
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
    • Richmond, Victoria, Australia, 3121
      • Victorian Heart Clinic
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Hospital
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
    • Perth, Western Australia, Australia, 6000
      • Royal Perth Hospital
• Austria
  • Linz, Austria, 4010
    • Krankenhaus der barmherzigen Schwestern
  • Wien, Austria, 1090
    • Univ. Klinik f. Innere Medizin II
  • Wien, Austria, 1171
    • Wilhelminenspital
• Belgium
  • Antwerpen, Belgium, 2020
    • Az Middelheim
  • Liege, Belgium, 4000
    • CHR de la Citadelle
  • Brabant
    • Leuven, Brabant, Belgium, 3000
      • U.Z. Gasthuisberg
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • ZOL Campus Sint-Jan
  • Vlaanderen
    • Roeselare, Vlaanderen, Belgium, 8800
      • Helig Hartziekenhuis
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2W8
      • Foothills Medical Centre
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital
    • Vancouver, British Columbia, Canada, V5Z 1L8
      • Vancouver General Hospital
    • Victoria, British Columbia, Canada, V8R 4R2
      • Royal Jubilee Hospital
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital - New Brunswick Heart Centre
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3E4
      • General Hospital Health Sciences Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
    • Mississauga, Ontario, Canada, L58 2P7
      • Trillium Health Center
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook & Women's Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Hopital Sacre-Coeur de Montreal
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute/Research Centre
    • Montreal, Quebec, Canada, H2L 4M1
      • Centre Hospitale de'Universite de Montreal (Pav Notre-Dame)_
    • Sainte-Foy, Quebec, Canada, G1V 4G5
      • Quebec Heart Institute/Laval Hospital
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 0W5
      • Regina General Hospital
• Czechia
  • Brno, Czechia, 625 00
    • Interni kardiologicka klinika, Fakultni nemocnice Brno
  • Brno, Czechia, 656 91
    • I. interni kardioangiologicka klinika, Fakultni nemocnice u Sv. Anny
  • Liberec, Czechia, 460 63
    • Kardiologicke odd., Krajska neocnice Liberec
  • Olomouc, Czechia, 775-20
    • I. Interni klinika, FN Olomouc
  • Ostrava, Czechia, 708 52
    • Interni klinika, FNsP Ostrava
  • Pardubice, Czechia, 532 03
    • Kardio-Troll sro and Krajska nemocnice Pardubice
  • Pardubice, Czechia, 53203
    • Kardio-Troll sro and Krajska nemocnice Pardubice
  • Plzen, Czechia, 304 60
    • I. Interni klinika, Fakultni nemocnice Plzen
  • Prague, Czechia, 10034
    • Kardiocentrum, Fakultni nemocnice Kralovske Vinohrady
  • Prague, Czechia, 128 08
    • II. Interni klinika, Vseobecna fakultni nemocnice
  • Prague, Czechia, 150 30
    • Kardiologicke odd., Nemocnice Na Homoice
  • Prague, Czechia, 15006
    • Kardiologicka klinika FN v Motole
  • Trinec, Czechia, 739 61
    • Kardiocentrum, Nemocnice Podlesi sro
  • Zlin, Czechia, 462 75
    • Interni klinika, Batova nemocnice
  • Ceske Budejovice
    • Caske Budejovice, Ceske Budejovice, Czechia, 370 878
      • Kardiologicke odd. Nemocnice Ceske Budejovice as
  • Hradec Kralove
    • Kradec Kralove, Hradec Kralove, Czechia, 500 05
      • I. Interni klinika, Fakultni nemocnice Hradec
  • Prague
    • Prague 4, Prague, Czechia, 14021
      • Klinika kardiologie, IKEM
  • Usti Nad Labem
    • Labem, Usti Nad Labem, Czechia, 401 13
      • Kardiologicke oddeleni, Masarykova nemocnice
• Denmark
  • Odense, Denmark, 5000
    • Odense Universitets Hospital
  • Danmark
    • Aalborg, Danmark, Denmark, 9100
      • Aalborg Sygehus
    • Aarhus, Danmark, Denmark, 8200
      • Skejby Sygehus
    • Hellerup, Danmark, Denmark, 2900
      • Amtssygehuset i Gentofte
    • Kobenhavn, Danmark, Denmark, DK-2100
      • Rigshospitalet
• France
  • Angers, France, 49100
    • CHRU de Angers
  • Colmar Cedex, France, 66027
    • Clinique Saint Joseph
  • Eaubonne-Montmorency, France, 95601
    • Cardiologie Hopital Simone Veil
  • Haguenau, France, 67504
    • Centre Hospitalier de Haguenau
  • Nantes, France, 44000
    • CHRU de Nantes
  • Paris, France, 75010
    • Hôpital Lariboisière
  • Paris, France, 75018
    • Hôpital Bichat
  • Paris Cedex 13, France, 75743
    • Hopital a Pitie Salpetriere
  • Pessac, France, 33604
    • Hôpital du Haut Lévêque
  • Rennes, France, 35000
    • Hôpital Pontchaillou
  • Rouen, France, 76000
    • CHRU de Rouen
  • Saint Denis, France, 93200
    • Centre Cardiologique du Nord
  • Strasbourg, France, 67100
    • CHRU Hautepierre
  • Toulouse Cedex 9, France, 31059
    • Hôpital Rangueil
  • Vandoeuvre les Nancy, France, 54511
    • Hopital d'adultes de Brabois (CHU de Nancy)
• Germany
  • Bad Oeynhausen, Germany, 32545
    • Universitätsklinik Der Ruhr-Universität Bochum
  • Berlin, Germany, 10967
    • Vivantes Klinikum Am Urban
  • Berlin, Germany, 10249
    • Vivantes Klinikkum im Friedrichshain
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf
  • Hamburg, Germany, 20099
    • Allgemeines Krankenhaus St. Georg
  • Baden-Wurttemberg
    • Mannheim, Baden-Wurttemberg, Germany, 66167
      • Universitätsklinikum Mannheim
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Klinikum Augsburg, Stenglinstr. 2.
    • Coburg, Bavaria, Germany, 96450
      • Klinikum Coburg
    • Munchen, Bavaria, Germany, 81925
      • Stadt Krankenhaus Muenchen-Bogenhausen
  • Hessen
    • Bad Nauheim, Hessen, Germany, 61231
      • Kerckhoff-Klinik Bad Anuheim
    • Kassel, Hessen, Germany, 34125
      • Stadt. Kliniken Kassel
  • Lower Saxony
    • Celle, Lower Saxony, Germany, 29223
      • Allgemeines Krankenhaus Celle
    • Gottingen, Lower Saxony, Germany, 37075
      • Herzzentrum Göttingen
  • Nordhein Westfalen
    • Dortmund, Nordhein Westfalen, Germany, 44137
      • St. Johannes Krankenhaus
    • Duisburg, Nordhein Westfalen, Germany, 47137
      • Herzzentrum Duisburg
  • Nordrhein Westfalen
    • Koln, Nordrhein Westfalen, Germany, 51109
      • Kliniken der Stadt Köln
    • Wuppertal, Nordrhein Westfalen, Germany, 42117
      • HELIOS Klinikum Wuppertal GmbH
  • North Rhine-Westphalia
    • Detmold, North Rhine-Westphalia, Germany, 32756
      • Klinikkum Lippe
  • Rhineland-Palatinate
    • Ludwigshafen, Rhineland-Palatinate, Germany, 67063
      • Klinikkum Ludwigshafen
  • Schleswig Holstein
    • Bad Segeberg, Schleswig Holstein, Germany, 23795
      • Herzzentrum
  • Schleswig-Holstein
    • Lubeck, Schleswig-Holstein, Germany, 23538
      • Universitatsklinik Lubeck
  • Thuringia
    • Jena, Thuringia, Germany, 07740
      • Klinik fur Innere Medizin 1
  • Wurrtemberg
    • Krozingen, Wurrtemberg, Germany, 79189
      • Herz-Zentrum Bad Krozingen
• Italy
  • Alessandria, Italy, 15100
    • A.O. SS. Antonio e Biagio e Cesare Arrigo
  • Bologna, Italy, 40128
    • Policlinico Sant'Orsola-Malpighi
  • Bolzano, Italy, 39100
    • Ospedale Centrale di Bolzano
  • Brescia, Italy, 25123
    • A.O. Spedali di Civili
  • Como, Italy, 22100
    • A.O. della Regione Lombardia Presidio Ospedaliero Sant'Anna
  • Lecco, Italy, 23900
    • Ospedale Alessandro Manzoni
  • Mantova, Italy, 46100
    • Azienda Ospedaliera Carlo Poma
  • Parma, Italy, 43100
    • Azienda Ospedaliera di Parma - Ospedale Maggiore
  • Pavia, Italy, 27100
    • Policlinico San Matteo - I.R.C.C.S.
  • Pesaro, Italy, 46100
    • A. O. S. Salvatore
  • Rimni, Italy, 47900
    • Osepdale degli Intermi
  • Roma, Italy, 00152
    • AO S. Camillo Forlanini
  • Torino, Italy, 10126
    • Cardiologia Universitaria
  • Treviso, Italy, 31100
    • Ospedale S. Maria di Ca'Foncello
  • Milano
    • San Donato Milanese, Milano, Italy, 20097
      • Centro E Malan
  • Padova
    • Cittadella, Padova, Italy, 35013
      • Presidio Ospedaliero di Cittadella
  • Reggio Emilla
    • Reggio Nell Emilia, Reggio Emilla, Italy, 42100
      • U.O. Cardiologia
• Netherlands
  • BR
    • Eindhovenb, BR, Netherlands, 5623 EJ
      • Catharina Hospital
  • LI
    • Maastricht, LI, Netherlands, 6229 HX
      • Academic Hospital Maastricht
  • NH
    • Alkmaar, NH, Netherlands, 1800 AM
      • Medeisch Centrum Alkmaar
    • Amsterdam, NH, Netherlands, 1081 HV
      • VUMC
    • Amsterdam, NH, Netherlands, 1091 HD
      • OLVG
  • OV
    • Zwolle, OV, Netherlands, 8011 JW
      • Isla Klinieken Location De Weezenlanden
  • UT
    • Nieuwegein, UT, Netherlands, 3435 CM
      • Sint Antonius Hospital
    • Ultrecht, UT, Netherlands, 3584 CX
      • University Medical Center Utrecht
  • ZH
    • Rotterdam, ZH, Netherlands, 3015 GD
      • Erasmus Medical Centre
    • Rotterdam, ZH, Netherlands, 3075 EA
      • Medisch Centrum Rijnmond-Zuid
• New Zealand
  • Auckland, New Zealand, 1003
    • Auckland City Hospital
  • Wellington, New Zealand, 6002
    • Wellington Hospital
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8001
      • Christchurch Hospital
  • Otago
    • Dunedin, Otago, New Zealand, 9001
      • Dunedin Hospital
  • Waikoto
    • Hamilton, Waikoto, New Zealand, 2001
      • Waikato Hospital
• Poland
  • Katowice - Ochojec, Poland, 40-635
    • I Klinika Kardiologii
  • Krakow, Poland, 31-202
    • Klinika Chorob Serca i Naczyn
  • Lodz, Poland, 91-347
    • II Katedra i Klinika Kardiologii
  • Warszawa, Poland, 04-628
    • I Klinika Choroby Wiencowej
  • Wroclaw, Poland, 50-420
    • SPZOZ Dolnoslaski Szpital Specjalistyczny
• Portugal
  • Amadora, Portugal, 3700-376 Amadora
    • H. Fernando da Fonesca
  • Coimbra, Portugal, 3000-075 Coimbra
    • Hospitals da Universidade de Coimbra
  • Lisboa, Portugal, 1069-166 Lisboa
    • Hospital Curry Cabral
  • Lisboa, Portugal, 1600-190 LISBOA
    • H. Santa Maria
  • Porto, Portugal, 4200-319 Porto
    • Hospital Sao Joao - Servico de Cardiologia
  • Vila Nova De Gala, Portugal, 4434-502 Vila Nova de Gala
    • Centro Hospitalar de Vila Nova de Gala
  • Lisboa
    • Almada, Lisboa, Portugal, 2801-951 Almada
      • Hospital Garcia de Orta - Servico de Cardiologia
    • Carnaxide, Lisboa, Portugal, 270-134
      • Hospital Santa Cruz
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08036
    • Hospital Clinic I Provincial
  • Leon, Spain, 24008
    • Hospital de Leon
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28035
    • Hospital Puerta de Hierro
  • Malaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de La Victoria
  • Sevilla, Spain, 41013
    • Hopspital Virgen del Rocio
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Ciutat Sanitaria i Universitaria de Bellvitge
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Virgen da la Arrixaca
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital De Navarra
• Sweden
  • Umea, Sweden, SE-901-85
    • Universitetetssjukhuset Umea
  • Uppsala, Sweden
    • Uppsala University Hospital
• Switzerland
  • Bassel, Switzerland, 4031
    • Kantonsspital Basel
  • Geneva
    • Geneva 14, Geneva, Switzerland, CH-1211
      • University Hospital of Geneva
  • Saint Gallen
    • St. Gallen, Saint Gallen, Switzerland, CH-9007
      • Kantonsspital St. Gallen
  • Thurgau
    • Kreuzlingen, Thurgau, Switzerland, 8280
      • Herzklinik Bodensee am Weinberg AG
  • Ticino
    • Lugano, Ticino, Switzerland, 6900
      • Cardiocentro Ticino
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Huntsville Hospital
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Hospital
    • Phoenix, Arizona, United States
      • North Phoenix Heart Center
    • Tucson, Arizona, United States, 85741
      • Northwest Medical Center
  • Arkansas
    • Fort Smith, Arkansas, United States, 72901
      • Sparks Regional Medical Center
    • Little Rock, Arkansas, United States, 72211
      • Arkansas State Hospital
  • California
    • Beverly Hills, California, United States, 90230
      • Brotman Medical Center
    • Burbank, California, United States, 91505
      • Providence Saint Joseph Medical Center
    • Escondido, California, United States, 92025
      • Palomar Medical Center
    • Los Angeles, California, United States, 90033
      • Los Angeles Community Hospital
    • Modesto, California, United States, 48201
      • Memorial Medical Center
    • Sacramento, California, United States, 95825
      • Sutter Memorial Hospital
    • San Diego, California, United States, 92103-8784
      • University of CA, San Diego Medical
    • Santa Rosa, California, United States, 95403
      • Sutter Medical Center of Santa Rosa
    • Valencia, California, United States, 91355
      • Providence Holy Cross Medical Center
  • Colorado
    • Denver, Colorado, United States, 80262
      • University of Colorado Hospital
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • St. Vincent Medical Center
    • Farmington, Connecticut, United States, 06030-2202
      • University of Connecticut Health Center
    • New Haven, Connecticut, United States, 06520
      • Yale - New Haven
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Hospital
  • Florida
    • Atlantis, Florida, United States, 33462
      • JFK Medical Center
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Fort Lauderdale, Florida, United States, 33308
      • North Ridge Medical Center
    • Jacksonville, Florida, United States, 32224
      • St. Luke's Hospital
    • Melbourne, Florida, United States, 32001
      • Health First Holmes Regional Medical Center
    • Orlando, Florida, United States, 32803
      • Florida Heart Hospital
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
    • Tampa, Florida, United States, 33613
      • University Community Hospital
  • Idaho
    • Boise, Idaho, United States, 63704
      • St. Luke's Regional Medical Center
  • Illinois
    • Bannockburn, Illinois, United States, 60015
      • Highland Park Hospital
    • Harvey, Illinois, United States, 80426
      • Ingalls Hospital
    • Lombard, Illinois, United States, 60148
      • Advocate Good Samaritan
    • Lombard, Illinois, United States, 60148
      • Elmhurst Hospital
    • Moline, Illinois, United States, 61265
      • Trinity Medical Center
    • Peoria, Illinois, United States, 61603
      • Saint Francis Medical Center
    • Rock Island, Illinois, United States, 61201
      • Trinity Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Methodist Hospital
    • Indianapolis, Indiana, United States, 46227
      • Community Hospital South
    • Indianapolis, Indiana, United States, 46202
      • VAMC
    • Indianapolis, Indiana, United States, 56250
      • The Indiana Heart Hospital
    • Munster, Indiana, United States, 46321
      • Munster Community Hospital
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Iowa Heart
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Via Christi Reginal Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
    • Lexington, Kentucky, United States, 40536-0200
      • University of Kentucky
    • Louisville, Kentucky, United States, 40207
      • Baptist Hospital East
    • Louisville, Kentucky, United States, 40202
      • The Jewish Hospital
  • Louisiana
    • Chalmette, Louisiana, United States, 70043
      • Lousiana Heart Center
    • Lacombe, Louisiana, United States, 70445
      • Lousiana Heart Hospital
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Hospital and Clinic
    • New Orleans, Louisiana, United States, 70112
      • MCLNO at New Orleans University Campus
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Towson, Maryland, United States, 21204
      • St. Joseph Medical Center
  • Michigan
    • Dearborn, Michigan, United States, 48123
      • Oakwood Hospital and Medical Center
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48235
      • Sinai-Grace Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health
    • Kalamazoo, Michigan, United States, 49048
      • Borgess Medical Center
    • Muskegon, Michigan, United States, 49444
      • Mercy General Health Partners
    • Petoskey, Michigan, United States, 49770
      • Northern Michigan Hospital
    • Pontiac, Michigan, United States, 48341-2982
      • St. Joseph Mercy-Oakland
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
    • Saginaw, Michigan, United States, 48601
      • Covenant Medical Center
    • Saginaw, Michigan, United States, 48601
      • Saint Mary Medical Center
    • Southfield, Michigan, United States, 48075
      • Providence Hospital
    • Troy, Michigan, United States, 48085
      • William Beaumont Hospital
    • Warren, Michigan, United States, 48201
      • Harper University Hospital
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Hospital
    • Duluth, Minnesota, United States, 55805
      • St. Mary's Duluth Clinic Health System
    • Edina, Minnesota, United States, 55435
      • Fairview Southdale Hospital
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
    • Minneapolis, Minnesota, United States, 55422
      • North Memorial Medical Center
    • Rochester, Minnesota, United States, 55902
      • Saint Mary Hospital
    • Saint Cloud, Minnesota, United States, 56303
      • St. Cloud Hospital
    • Saint Louis Park, Minnesota, United States, 55426
      • Methodist Hospital
    • Saint Paul, Minnesota, United States, 55102
      • Health East St. Joseph Hospital
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health Sciences Center
    • Saint Louis, Missouri, United States, 63110
      • St. Louis University Hospital
    • Saint Louis, Missouri, United States, 63122
      • Barnes St. Peters Hospital
    • Springfield, Missouri, United States, 65807
      • St. John's Hospital
  • Montana
    • Billings, Montana, United States, 59101
      • Deaconess Billings Clinic
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • St. Elizabeth Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Sunrise Hospital
  • New Jersey
    • Elizabeth, New Jersey, United States, 07202
      • Trinitas Hospital
    • Fair Lawn, New Jersey, United States, 07410
      • St. Joseph's Regional Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute
  • New York
    • Albany, New York, United States, 12211
      • Albany Medical Center
    • Bronx, New York, United States, 10467
      • Monteflore Medical Center
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center
    • Johnson City, New York, United States, 13790
      • Wilson Memorial Medical Center
    • Mineola, New York, United States, 11504
      • Winthrop University Hospital
    • New York, New York, United States, 10016
      • Bellevue Hospital Center
    • New York, New York, United States, 10011
      • St. Vincent's Catholic Medical Center
    • Poughkeepsie, New York, United States, 12601
      • Vassar Brothers Medical Center
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
    • Syracuse, New York, United States, 13210
      • SUNY - Upstate Medical University
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Presbyterian Hospital
    • Durham, North Carolina, United States, 27705
      • Duke University Health Systems
    • Greensboro, North Carolina, United States, 27401
      • Moses Cone Hospital/LeBauer Healthcare
    • Greenville, North Carolina, United States, 27834
      • Pitt County Memorial Hospital
    • High Point, North Carolina, United States, 27262
      • High Point Regional Health System
  • North Dakota
    • Minot, North Dakota, United States, 58701
      • Trinity Hospital
  • Ohio
    • Akron, Ohio, United States, 44307
      • Akron General Medical Center
    • Cincinnati, Ohio, United States, 45242
      • Bethesda North Hospital
    • Cincinnati, Ohio, United States, 45220
      • VAMC Cincinnati
    • Cincinnati, Ohio, United States, 45267
      • The University Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44103
      • University Hospitals of Cleveland
    • Columbus, Ohio, United States, 43214
      • MidWest Cardiology Research Foundation
    • Mansfield, Ohio, United States, 44906
      • Med Central Mansfield
    • Zanesville, Ohio, United States, 43701
      • Genesis HealthCare System
  • Oklahoma
    • Midwest City, Oklahoma, United States, 73110
      • Midwest Regional Medical Center
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital
    • Oklahoma City, Oklahoma, United States, 73112
      • INTEGRIS Baptist Medical Center, Inc.
    • Oklahoma City, Oklahoma, United States, 73104
      • VA Medical Center
  • Oregon
    • Bend, Oregon, United States, 97701
      • St. Charles Medical Center
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18105
      • Lehigh Valley Hospital
    • Danville, Pennsylvania, United States, 17822-2160
      • Geisinger Medical Center
    • Davenport, Pennsylvania, United States, 58803
      • Genesis Medical Center
    • Erie, Pennsylvania, United States, 16550
      • Hamot Medical Center
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster General Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System
    • Pittsburgh, Pennsylvania, United States, 15025
      • Jefferson Regional Medical Center
    • Pittsburgh, Pennsylvania, United States, 15215
      • Western Pennsylvania Hospital
    • West Chester, Pennsylvania, United States, 19380
      • The Chester County Hospital
    • York, Pennsylvania, United States, 17405
      • York Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Palmetto Richland Memorial Hospital
    • Columbia, South Carolina, United States, 29204
      • Sisters of Charity Providence Hospitals
  • South Dakota
    • Rapid City, South Dakota, United States, 57719
      • Rapid City Regional Hospital
    • Sioux Falls, South Dakota, United States, 57108
      • Heart Hospital of South Dakota
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Jackson-Madison County General Hospital
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Holston Valley Medical Center
    • Knoxville, Tennessee, United States, 37920
      • Baptist Hospital of East Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Fort Sanders Rgional Medical Center
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center
    • Oak Ridge, Tennessee, United States, 37830
      • Methodist Medical Center
  • Texas
    • Amarillo, Texas, United States, 79106
      • Northwest Texas Healthcare System
    • Austin, Texas, United States, 78705
      • Seton Medical Center
    • Dallas, Texas, United States, 75230
      • Medical City Dallas
    • Dallas, Texas, United States, 75390
      • Parkland Health & Hospital System
    • Dallas, Texas, United States, 57231
      • Presbyterian Hospital of Dallas
    • Dallas, Texas, United States, 75390
      • Dallas Medical Center
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center
    • Houston, Texas, United States, 77030
      • Michael E. DeBakey VA Medical Center
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital
    • Houston, Texas, United States, 77090
      • Houston Northwest Medical Center
    • Lubbock, Texas, United States, 79410
      • Covenant Medical Center
    • San Antonio, Texas, United States, 78217
      • Northeast Baptist Hospital
    • San Antonio, Texas, United States, 78258
      • South Texas Veterans Health Care System Audie L. Murphy Division
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Hospital
    • Tyler, Texas, United States, 75701
      • East Texas Medical Center
    • Tyler, Texas, United States, 75701
      • Trinity Mother Frances Hospital
    • Victoria, Texas, United States, 77901
      • Citizens Medical Center
    • Victoria, Texas, United States, 77901
      • Detar Hospital
  • Utah
    • Murray, Utah, United States, 84107
      • Cottonwood Hospital
  • Virginia
    • Alexandria, Virginia, United States, 22306
      • Inova Alexandria Hospital
    • Charlottesville, Virginia, United States, 22908
      • Universitiy of Virginia Health Science Center
    • Harrisonburg, Virginia, United States, 22801
      • Rockingham Memorial Hospital
    • Lynchburg, Virginia, United States, 24501
      • Lynchburg General Hospital
    • Richmond, Virginia, United States
      • Herrico Doctors' Hospital - Forest
    • Virginia Beach, Virginia, United States, 23454
      • Sentara Virginia Beach General Hospital
    • Winchester, Virginia, United States, 22601
      • Winchester Medical Center
  • Washington
    • Bellevue, Washington, United States, 98004
      • Overtake Hospital Medical Center
    • Mount Vernon, Washington, United States, 98274
      • Skagit Valley Hospital
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center
    • Tacoma, Washington, United States, 98405
      • MultiCare Medical Center (Tacoma General Hospital)
    • Tacoma, Washington, United States, 98405
      • St. Joseph Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506-9157
      • West Virginia University Hospital
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Franciscan Skemp Healthcare
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital
    • Waukesha, Wisconsin, United States, 53188
      • Waukesha Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cardiac symptoms for at least 20 minutes within past 6 hours;
• Will undergo primary PCI;
• Has ECG evidence of acute high risk ST elevation myocardial infarction;
• Willing and able to be followed for at least 12 months.

Exclusion Criteria:

• Isolated low risk inferior wall myocardial infarction;
• Received fibrinolytic therapy;
• History of complement deficiency;
• Suspected neisserial infection;
• Participating in other investigational study;
• Pregnancy;
• Previous enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Placebo infusion	Drug: Placebo infusion; bolus infusion over a 10 minute period once
Experimental: 2; Pexelizumab infusion	Drug: Pexelizumab; Pexelizumab (2 mg/kg) intravenous , bolus for 10 minutes once

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction of all causes of mortality	day 30

Collaborators and Investigators

• Sponsor: Procter and Gamble
• Investigators: Study Director: Thomas G Todaro, MD, JD, FACC, Procter and Gamble

Publications and helpful links

General Publications

• Bagai A, Armstrong PW, Stebbins A, Mahaffey KW, Hochman JS, Weaver WD, Patel MR, Granger CB, Lopes RD. Prognostic implications of left ventricular end-diastolic pressure during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: Findings from the Assessment of Pexelizumab in Acute Myocardial Infarction study. Am Heart J. 2013 Nov;166(5):913-9. doi: 10.1016/j.ahj.2013.08.006. Epub 2013 Sep 24.
• Guptill JT, Mehta RH, Armstrong PW, Horton J, Laskowitz D, James S, Granger CB, Lopes RD. Stroke after primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction: timing, characteristics, and clinical outcomes. Circ Cardiovasc Interv. 2013 Apr;6(2):176-83. doi: 10.1161/CIRCINTERVENTIONS.112.000159. Epub 2013 Apr 2.
• Westerhout CM, Pieper KS, James SK, Mahaffey KW, de Werf FV, Califf RM, Granger CB, Armstrong PW. Dynamic modeling of 90-day mortality in ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention. Am Heart J. 2013 Mar;165(3):354-62.e2. doi: 10.1016/j.ahj.2012.12.001. Epub 2013 Jan 15.
• Patel MR, Westerhout CM, Granger CB, Brener SJ, Fu Y, Siha H, Kim RJ, Armstrong PW. Aborted myocardial infarction after primary percutaneous coronary intervention: magnetic resonance imaging insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2013 Feb;165(2):226-33. doi: 10.1016/j.ahj.2012.10.028. Epub 2012 Nov 24.
• Truffa AA, Granger CB, White KR, Newby LK, Mehta RH, Hochman JS, Patel MR, Pieper KS, Al-Khalidi HR, Armstrong PW, Lopes RD. Serious infection after acute myocardial infarction: incidence, clinical features, and outcomes. JACC Cardiovasc Interv. 2012 Jul;5(7):769-76. doi: 10.1016/j.jcin.2012.03.018.
• Martel C, Granger CB, Ghitescu M, Stebbins A, Fortier A, Armstrong PW, Bonnefoy A, Theroux P. Pexelizumab fails to inhibit assembly of the terminal complement complex in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Insight from a substudy of the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2012 Jul;164(1):43-51. doi: 10.1016/j.ahj.2012.04.007. Epub 2012 Jun 15.
• van Diepen S, Widimsky P, Lopes RD, White KR, Weaver WD, Van de Werf F, Ardissino D, van't Hof AW, Armstrong PW, Granger CB. Transfer times and outcomes in patients with ST-segment-elevation myocardial infarction undergoing interhospital transfer for primary percutaneous coronary intervention: APEX-AMI insights. Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):437-44. doi: 10.1161/CIRCOUTCOMES.112.965160. Epub 2012 May 15.
• Hudson MP, Armstrong PW, O'Neil WW, Stebbins AL, Weaver WD, Widimsky P, Aylward PE, Ruzyllo W, Holmes D, Mahaffey KW, Granger CB. Mortality implications of primary percutaneous coronary intervention treatment delays: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction trial. Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):183-92. doi: 10.1161/CIRCOUTCOMES.110.945311. Epub 2011 Feb 8.
• Huber K, Holmes DR Jr, van 't Hof AW, Montalescot G, Aylward PE, Betriu GA, Widimsky P, Westerhout CM, Granger CB, Armstrong PW. Use of glycoprotein IIb/IIIa inhibitors in primary percutaneous coronary intervention: insights from the APEX-AMI trial. Eur Heart J. 2010 Jul;31(14):1708-16. doi: 10.1093/eurheartj/ehq143. Epub 2010 May 25.
• Alhadramy O, Westerhout CM, Brener SJ, Granger CB, Armstrong PW; APEX AMI Investigators. Is visual interpretation of coronary epicardial flow reliable in patients with ST-elevation myocardial infarction undergoing primary angioplasty? Insights from the angiographic substudy of the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2010 May;159(5):899-904. doi: 10.1016/j.ahj.2010.02.028.
• Patel MR, Worthley SG, Stebbins A, Dill T, Rademakers FE, Valeti US, Barsness GW, Van de Werf F, Hamm CW, Armstrong PW, Granger CB, Kim RJ. Pexelizumab and infarct size in patients with acute myocardial infarction undergoing primary percutaneous coronary Intervention: a delayed enhancement cardiac magnetic resonance substudy from the APEX-AMI trial. JACC Cardiovasc Imaging. 2010 Jan;3(1):52-60. doi: 10.1016/j.jcmg.2009.09.014. Epub 2010 Jan 12. Erratum In: JACC Cardiovasc Imaging. 2010 Jul;3(7):796. Velleti, Uma S [corrected to Valeti, Uma S].
• Trendelenburg M, Theroux P, Stebbins A, Granger C, Armstrong P, Pfisterer M. Influence of functional deficiency of complement mannose-binding lectin on outcome of patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Eur Heart J. 2010 May;31(10):1181-7. doi: 10.1093/eurheartj/ehp597. Epub 2010 Jan 19.
• Brener SJ, Westerhout CM, Fu Y, Todaro TG, Moliterno DJ, Wagner GS, Granger CB, Armstrong PW; APEX-AMI Investigators. Contribution of angiographic and electrocardiographic parameters of reperfusion to prediction of mortality and morbidity after acute ST-elevation myocardial infarction: Insights from the Assessment of Pexelizumab in Acute Myocardial Infarction trial. Am Heart J. 2009 Nov;158(5):755-60. doi: 10.1016/j.ahj.2009.09.009. Epub 2009 Oct 3.
• Armstrong PW, Fu Y, Westerhout CM, Hudson MP, Mahaffey KW, White HD, Todaro TG, Adams PX, Aylward PE, Granger CB. Baseline Q-wave surpasses time from symptom onset as a prognostic marker in ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention. J Am Coll Cardiol. 2009 Apr 28;53(17):1503-9. doi: 10.1016/j.jacc.2009.01.046.
• Buller CE, Fu Y, Mahaffey KW, Todaro TG, Adams P, Westerhout CM, White HD, van 't Hof AW, Van de Werf FJ, Wagner GS, Granger CB, Armstrong PW. ST-segment recovery and outcome after primary percutaneous coronary intervention for ST-elevation myocardial infarction: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Circulation. 2008 Sep 23;118(13):1335-46. doi: 10.1161/CIRCULATIONAHA.108.767772. Epub 2008 Sep 8.
• APEX AMI Investigators; Armstrong PW, Granger CB, Adams PX, Hamm C, Holmes D Jr, O'Neill WW, Todaro TG, Vahanian A, Van de Werf F. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial. JAMA. 2007 Jan 3;297(1):43-51. doi: 10.1001/jama.297.1.43.

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: September 14, 2004
• First Submitted That Met QC Criteria: September 15, 2004
• First Posted (Estimated): September 16, 2004

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 2003056