AzTrials
AzTrials

Acute Myocardial InfarctionPhase 3NCT00091637

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

A Phase 3 study testing Pexelizumab in people with Acute Myocardial Infarction, run by Procter and Gamble at 349 sites in 17 countries.

Completed

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

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Pexelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,745 participants
Where
349 sitesin 17 countries
Study dates
Apr 2004to May 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

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

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

349 sites in 17 countries.

349 sites in 17 countries

United States180 sites

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Albany Medical Center

    Albany, New York, 12211

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • Inova Alexandria Hospital

    Alexandria, Virginia, 22306

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • Northwest Texas Healthcare System

    Amarillo, Texas, 79106

  • JFK Medical Center

    Atlantis, Florida, 33462

  • Seton Medical Center

    Austin, Texas, 78705

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Highland Park Hospital

    Bannockburn, Illinois, 60015

  • Overtake Hospital Medical Center

    Bellevue, Washington, 98004

  • St. Charles Medical Center

    Bend, Oregon, 97701

  • Brotman Medical Center

    Beverly Hills, California, 90230

  • Deaconess Billings Clinic

    Billings, Montana, 59101

  • St. Luke's Regional Medical Center

    Boise, Idaho, 63704

  • St. Vincent Medical Center

    Bridgeport, Connecticut, 06606

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Providence Saint Joseph Medical Center

    Burbank, California, 91505

  • Lousiana Heart Center

    Chalmette, Louisiana, 70043

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • Universitiy of Virginia Health Science Center

    Charlottesville, Virginia, 22908

  • VAMC Cincinnati

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • The University Hospital

    Cincinnati, Ohio, 45267

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44103

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • University of Missouri Health Sciences Center

    Columbia, Missouri, 65212

  • Palmetto Richland Memorial Hospital

    Columbia, South Carolina, 29203

  • Sisters of Charity Providence Hospitals

    Columbia, South Carolina, 29204

  • MidWest Cardiology Research Foundation

    Columbus, Ohio, 43214

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Presbyterian Hospital of Dallas

    Dallas, Texas, 57231

  • Medical City Dallas

    Dallas, Texas, 75230

  • Dallas Medical Center

    Dallas, Texas, 75390

  • Parkland Health & Hospital System

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2160

  • Genesis Medical Center

    Davenport, Pennsylvania, 58803

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123

  • University of Colorado Hospital

    Denver, Colorado, 80262

  • Iowa Heart

    Des Moines, Iowa, 50314

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Sinai-Grace Hospital

    Detroit, Michigan, 48235

  • St. Mary's Duluth Clinic Health System

    Duluth, Minnesota, 55805

  • Duke University Health Systems

    Durham, North Carolina, 27705

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Trinitas Hospital

    Elizabeth, New Jersey, 07202

  • Hamot Medical Center

    Erie, Pennsylvania, 16550

  • Palomar Medical Center

    Escondido, California, 92025

  • St. Joseph's Regional Medical Center

    Fair Lawn, New Jersey, 07410

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030-2202

  • North Ridge Medical Center

    Fort Lauderdale, Florida, 33308

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Sparks Regional Medical Center

    Fort Smith, Arkansas, 72901

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • Moses Cone Hospital/LeBauer Healthcare

    Greensboro, North Carolina, 27401

  • Pitt County Memorial Hospital

    Greenville, North Carolina, 27834

  • Rockingham Memorial Hospital

    Harrisonburg, Virginia, 22801

  • Ingalls Hospital

    Harvey, Illinois, 80426

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • High Point Regional Health System

    High Point, North Carolina, 27262

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • Memorial Hermann Hospital

    Houston, Texas, 77030

  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030

  • Houston Northwest Medical Center

    Houston, Texas, 77090

  • Huntsville Hospital

    Huntsville, Alabama, 35801

  • Methodist Hospital

    Indianapolis, Indiana, 46202

  • VAMC

    Indianapolis, Indiana, 46202

  • Community Hospital South

    Indianapolis, Indiana, 46227

  • The Indiana Heart Hospital

    Indianapolis, Indiana, 56250

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • St. Luke's Hospital

    Jacksonville, Florida, 32224

  • Wilson Memorial Medical Center

    Johnson City, New York, 13790

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37660

  • Fort Sanders Rgional Medical Center

    Knoxville, Tennessee, 37916

  • Baptist Hospital of East Tennessee

    Knoxville, Tennessee, 37920

  • Franciscan Skemp Healthcare

    La Crosse, Wisconsin, 54601

  • Lousiana Heart Hospital

    Lacombe, Louisiana, 70445

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • Sunrise Hospital

    Las Vegas, Nevada, 89109

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • University of Kentucky

    Lexington, Kentucky, 40536-0200

  • St. Elizabeth Medical Center

    Lincoln, Nebraska, 68510

  • Arkansas State Hospital

    Little Rock, Arkansas, 72211

  • Advocate Good Samaritan

    Lombard, Illinois, 60148

  • Elmhurst Hospital

    Lombard, Illinois, 60148

  • Los Angeles Community Hospital

    Los Angeles, California, 90033

  • The Jewish Hospital

    Louisville, Kentucky, 40202

  • Baptist Hospital East

    Louisville, Kentucky, 40207

  • Covenant Medical Center

    Lubbock, Texas, 79410

  • Lynchburg General Hospital

    Lynchburg, Virginia, 24501

  • Med Central Mansfield

    Mansfield, Ohio, 44906

  • Health First Holmes Regional Medical Center

    Melbourne, Florida, 32001

  • Midwest Regional Medical Center

    Midwest City, Oklahoma, 73110

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • Winthrop University Hospital

    Mineola, New York, 11504

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • North Memorial Medical Center

    Minneapolis, Minnesota, 55422

  • Trinity Hospital

    Minot, North Dakota, 58701

  • Memorial Medical Center

    Modesto, California, 48201

  • Trinity Medical Center

    Moline, Illinois, 61265

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506-9157

  • Skagit Valley Hospital

    Mount Vernon, Washington, 98274

  • Munster Community Hospital

    Munster, Indiana, 46321

  • Cottonwood Hospital

    Murray, Utah, 84107

  • Mercy General Health Partners

    Muskegon, Michigan, 49444

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Yale - New Haven

    New Haven, Connecticut, 06520

  • MCLNO at New Orleans University Campus

    New Orleans, Louisiana, 70112

  • Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • St. Vincent's Catholic Medical Center

    New York, New York, 10011

  • Bellevue Hospital Center

    New York, New York, 10016

  • Methodist Medical Center

    Oak Ridge, Tennessee, 37830

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • VA Medical Center

    Oklahoma City, Oklahoma, 73104

  • Integris Baptist Medical Center, Inc.

    Oklahoma City, Oklahoma, 73112

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

  • Florida Heart Hospital

    Orlando, Florida, 32803

  • Saint Francis Medical Center

    Peoria, Illinois, 61603

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • North Phoenix Heart Center

    Phoenix, Arizona

  • Jefferson Regional Medical Center

    Pittsburgh, Pennsylvania, 15025

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15215

  • VA Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • St. Joseph Mercy-Oakland

    Pontiac, Michigan, 48341-2982

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57719

  • Herrico Doctors' Hospital - Forest

    Richmond, Virginia

  • Saint Mary Hospital

    Rochester, Minnesota, 55902

  • Rochester General Hospital

    Rochester, New York, 14621

  • Trinity Medical Center

    Rock Island, Illinois, 61201

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Sutter Memorial Hospital

    Sacramento, California, 95825

  • Covenant Medical Center

    Saginaw, Michigan, 48601

  • Saint Mary Medical Center

    Saginaw, Michigan, 48601

  • St. Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Methodist Hospital

    Saint Louis Park, Minnesota, 55426

  • Health East St. Joseph Hospital

    Saint Paul, Minnesota, 55102

  • Northeast Baptist Hospital

    San Antonio, Texas, 78217

  • South Texas Veterans Health Care System Audie L. Murphy Division

    San Antonio, Texas, 78258

  • University of CA, San Diego Medical

    San Diego, California, 92103-8784

  • Sutter Medical Center of Santa Rosa

    Santa Rosa, California, 95403

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Heart Hospital of South Dakota

    Sioux Falls, South Dakota, 57108

  • Providence Hospital

    Southfield, Michigan, 48075

  • St. John's Hospital

    Springfield, Missouri, 65807

  • St. Louis University Hospital

    St Louis, Missouri, 63110

  • Barnes St. Peters Hospital

    St Louis, Missouri, 63122

  • SUNY - Upstate Medical University

    Syracuse, New York, 13210

  • MultiCare Medical Center (Tacoma General Hospital)

    Tacoma, Washington, 98405

  • St. Joseph Medical Center

    Tacoma, Washington, 98405

  • University Community Hospital

    Tampa, Florida, 33613

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • Monteflore Medical Center

    The Bronx, New York, 10467

  • St. Joseph Medical Center

    Towson, Maryland, 21204

  • William Beaumont Hospital

    Troy, Michigan, 48085

  • Northwest Medical Center

    Tucson, Arizona, 85741

  • East Texas Medical Center

    Tyler, Texas, 75701

  • Trinity Mother Frances Hospital

    Tyler, Texas, 75701

  • Providence Holy Cross Medical Center

    Valencia, California, 91355

  • Citizens Medical Center

    Victoria, Texas, 77901

  • Detar Hospital

    Victoria, Texas, 77901

  • Sentara Virginia Beach General Hospital

    Virginia Beach, Virginia, 23454

  • Harper University Hospital

    Warren, Michigan, 48201

  • George Washington University Hospital

    Washington D.C., District of Columbia, 20037

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • The Chester County Hospital

    West Chester, Pennsylvania, 19380

  • Via Christi Reginal Medical Center

    Wichita, Kansas, 67214

  • Winchester Medical Center

    Winchester, Virginia, 22601

  • York Hospital

    York, Pennsylvania, 17405

  • Genesis Healthcare System

    Zanesville, Ohio, 43701

Other trials in United States

Germany23 sites

  • Klinikum Augsburg, Stenglinstr. 2.

    Augsburg, Bavaria, 86156

  • Kerckhoff-Klinik Bad Anuheim

    Bad Nauheim, Hesse, 61231

  • Universitatsklinik der Ruhr-Universitat Bochum

    Bad Oeynhausen, 32545

  • Herzzentrum

    Bad Segeberg, Schleswig-Holstein, 23795

  • Vivantes Klinikkum im Friedrichshain

    Berlin, 10249

  • Vivantes Klinikum am Urban

    Berlin, 10967

  • Allgemeines Krankenhaus Celle

    Celle, Lower Saxony, 29223

  • Klinikum Coburg

    Coburg, Bavaria, 96450

  • Kliniken der Stadt Koln

    Cologne, North Rhine-Westphalia, 51109

  • Klinikkum Lippe

    Detmold, North Rhine-Westphalia, 32756

  • St. Johannes Krankenhaus

    Dortmund, Nordhein Westfalen, 44137

  • Herzzentrum Duisburg

    Duisburg, Nordhein Westfalen, 47137

  • Herzzentrum Gottingen

    Göttingen, Lower Saxony, 37075

  • Allgemeines Krankenhaus St. Georg

    Hamburg, 20099

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Klinik fur Innere Medizin 1

    Jena, Thuringia, 07740

  • Stadt. Kliniken Kassel

    Kassel, Hesse, 34125

  • Herz-Zentrum Bad Krozingen

    Krozingen, Wurrtemberg, 79189

  • Universitatsklinik Lubeck

    Lübeck, Schleswig-Holstein, 23538

  • Klinikkum Ludwigshafen

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • Universitatsklinikum Mannheim

    Mannheim, Baden-Wurttemberg, 66167

  • Stadt Krankenhaus Muenchen-Bogenhausen

    München, Bavaria, 81925

  • Helios Klinikum Wuppertal GmbH

    Wuppertal, North Rhine-Westphalia, 42117

Other trials in Germany

Australia21 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Austin Hospital

    Box Hill, Victoria, 3084

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Prince Charles Hospital

    Chermside, Queensland, 4032

  • Monash Medical Centre

    Clayton, Victoria, 3162

  • Concord Hospital

    Concord, New South Wales, 2137

  • Townsville Hospital

    Douglas, Queensland, 4814

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Gosford Hospital

    Gosford, New South Wales, 2250

  • St. George Hospital

    Kogarah, New South Wales, 2217

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Victorian Heart Clinic

    Richmond, Victoria, 3121

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

  • Princess Alexandra Hospital

    Wooloong Abba, Queensland, 4102

Other trials in Australia

Czechia18 sites

  • Interni kardiologicka klinika, Fakultni nemocnice Brno

    Brno, 625 00

  • I. interni kardioangiologicka klinika, Fakultni nemocnice u Sv. Anny

    Brno, 656 91

  • Kardiologicke odd. Nemocnice Ceske Budejovice as

    Caske Budejovice, Ceske Budejovice, 370 878

  • I. Interni klinika, Fakultni nemocnice Hradec

    Kradec Kralove, Hradec Kralove, 500 05

  • Kardiologicke oddeleni, Masarykova nemocnice

    Labem, Usti Nad Labem, 401 13

  • Kardiologicke odd., Krajska neocnice Liberec

    Liberec, 460 63

  • I. Interni klinika, FN Olomouc

    Olomouc, 775-20

  • Interni klinika, FNsP Ostrava

    Ostrava, 708 52

  • Kardio-Troll sro and Krajska nemocnice Pardubice

    Pardubice, 532 03

  • Kardio-Troll sro and Krajska nemocnice Pardubice

    Pardubice, 53203

  • I. Interni klinika, Fakultni nemocnice Plzen

    Pilsen, 304 60

  • Klinika kardiologie, IKEM

    Prague, Prague, 14021

  • Kardiocentrum, Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034

  • II. Interni klinika, Vseobecna fakultni nemocnice

    Prague, 128 08

  • Kardiologicke odd., Nemocnice Na Homoice

    Prague, 150 30

  • Kardiologicka klinika FN v Motole

    Prague, 15006

  • Kardiocentrum, Nemocnice Podlesi sro

    Třinec, 739 61

  • Interni klinika, Batova nemocnice

    Zlín, 462 75

Other trials in Czechia

Italy17 sites

  • A.O. SS. Antonio e Biagio e Cesare Arrigo

    Alessandria, 15100

  • Policlinico Sant'Orsola-Malpighi

    Bologna, 40128

  • Ospedale Centrale di Bolzano

    Bolzano, 39100

  • A.O. Spedali di Civili

    Brescia, 25123

  • Presidio Ospedaliero di Cittadella

    Cittadella, Padova, 35013

  • A.O. della Regione Lombardia Presidio Ospedaliero Sant'Anna

    Como, 22100

  • Ospedale Alessandro Manzoni

    Lecco, 23900

  • Azienda Ospedaliera Carlo Poma

    Mantua, 46100

  • Azienda Ospedaliera di Parma - Ospedale Maggiore

    Parma, 43100

  • Policlinico San Matteo - I.R.C.C.S.

    Pavia, 27100

  • A. O. S. Salvatore

    Pesaro, 46100

  • U.O. Cardiologia

    Reggio Emilia, Reggio Emilla, 42100

  • Osepdale degli Intermi

    Rimni, Rimni, 47900

  • AO S. Camillo Forlanini

    Roma, 00152

  • Centro E Malan

    San Donato Milanese, Milano, 20097

  • Cardiologia Universitaria

    Torino, 10126

  • Ospedale S. Maria di Ca'Foncello

    Treviso, 31100

Other trials in Italy

Canada16 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2W8

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • Trillium Health Center

    Mississauga, Ontario, L58 2P7

  • Montreal Heart Institute/Research Centre

    Montreal, Quebec, H1T 1C8

  • Centre Hospitale de'Universite de Montreal (Pav Notre-Dame)_

    Montreal, Quebec, H2L 4M1

  • Hopital Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Regina General Hospital

    Regina, Saskatchewan, S4P 0W5

  • Saint John Regional Hospital - New Brunswick Heart Centre

    Saint John, New Brunswick, E2L 4L2

  • Quebec Heart Institute/Laval Hospital

    Sainte-Foy, Quebec, G1V 4G5

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • General Hospital Health Sciences Centre

    St. John's, Newfoundland and Labrador, A1B 3E4

  • Sunnybrook & Women's Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1L8

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • Royal Jubilee Hospital

    Victoria, British Columbia, V8R 4R2

Other trials in Canada

France15 sites

  • CHRU de Angers

    Angers, 49100

  • Clinique Saint Joseph

    Colmar, 66027

  • Cardiologie Hopital Simone Veil

    Eaubonne-Montmorency, 95601

  • Centre Hospitalier de Haguenau

    Haguenau, 67504

  • CHRU de Nantes

    Nantes, 44000

  • Hopital Lariboisiere

    Paris, 75010

  • Hopital Bichat

    Paris, 75018

  • Hopital a Pitie Salpetriere

    Paris, 75743

  • Hopital du Haut Leveque

    Pessac, 33604

  • Hopital Pontchaillou

    Rennes, 35000

  • CHRU de Rouen

    Rouen, 76000

  • Centre Cardiologique du Nord

    Saint-Denis, 93200

  • CHRU Hautepierre

    Strasbourg, 67100

  • Hopital Rangueil

    Toulouse, 31059

  • Hopital d'adultes de Brabois (CHU de Nancy)

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain11 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • Hospital Virgen da la Arrixaca

    El Palmar, Murcia, 30120

  • Ciutat Sanitaria i Universitaria de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital de Leon

    León, 24008

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Puerta de Hierro

    Madrid, 28035

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital de Navarra

    Pamplona, Navarre, 31008

  • Hopspital Virgen del Rocio

    Seville, 41013

Other trials in Spain

Netherlands10 sites

  • Medeisch Centrum Alkmaar

    Alkmaar, North Holland, 1800 AM

  • VUMC

    Amsterdam, North Holland, 1081 HV

  • OLVG

    Amsterdam, North Holland, 1091 HD

  • Catharina Hospital

    Eindhovenb, BR, 5623 EJ

  • Academic Hospital Maastricht

    Maastricht, LI, 6229 HX

  • Sint Antonius Hospital

    Nieuwegein, Utrecht, 3435 CM

  • Erasmus Medical Centre

    Rotterdam, South Holland, 3015 GD

  • Medisch Centrum Rijnmond-Zuid

    Rotterdam, South Holland, 3075 EA

  • University Medical Center Utrecht

    Ultrecht, Utrecht, 3584 CX

  • Isla Klinieken Location De Weezenlanden

    Zwolle, Overijssel, 8011 JW

Other trials in Netherlands

Portugal8 sites

  • Hospital Garcia de Orta - Servico de Cardiologia

    Almada, Lisbon District, 2801-951 Almada

  • H. Fernando da Fonesca

    Amadora, 3700-376 Amadora

  • Hospital Santa Cruz

    Carnaxide, Lisbon District, 270-134

  • Hospitals da Universidade de Coimbra

    Coimbra, 3000-075 Coimbra

  • Hospital Curry Cabral

    Lisbon, 1069-166 Lisboa

  • H. Santa Maria

    Lisbon, 1600-190 LISBOA

  • Hospital Sao Joao - Servico de Cardiologia

    Porto, 4200-319 Porto

  • Centro Hospitalar de Vila Nova de Gala

    Vila Nova de Gala, 4434-502 Vila Nova de Gala

Other trials in Portugal

Belgium5 sites

  • AZ Middelheim

    Antwerp, 2020

  • ZOL Campus Sint-Jan

    Genk, Limburg, 3600

  • U.Z. Gasthuisberg

    Leuven, Brabant, 3000

  • CHR de la Citadelle

    Liège, 4000

  • Helig Hartziekenhuis

    Roeselare, Flanders, 8800

Other trials in Belgium

Denmark5 sites

  • Aalborg Sygehus

    Aalborg, Danmark, 9100

  • Skejby Sygehus

    Aarhus, Danmark, 8200

  • Rigshospitalet

    Copenhagen, Danmark, DK-2100

  • Amtssygehuset i Gentofte

    Hellerup, Danmark, 2900

  • Odense Universitets Hospital

    Odense, 5000

Other trials in Denmark

New Zealand5 sites

  • Auckland City Hospital

    Auckland, 1003

  • Christchurch Hospital

    Christchurch, Canterbury, 8001

  • Dunedin Hospital

    Dunedin, Otago, 9001

  • Waikato Hospital

    Hamilton, Waikoto, 2001

  • Wellington Hospital

    Wellington, 6002

Other trials in New Zealand

Poland5 sites

  • I Klinika Kardiologii

    Katowice - Ochojec, 40-635

  • Klinika Chorob Serca i Naczyn

    Krakow, 31-202

  • II Katedra i Klinika Kardiologii

    Lodz, 91-347

  • I Klinika Choroby Wiencowej

    Warsaw, 04-628

  • SPZOZ Dolnoslaski Szpital Specjalistyczny

    Wroclaw, 50-420

Other trials in Poland

Switzerland5 sites

  • Kantonsspital Basel

    Bassel, Bassel, 4031

  • University Hospital of Geneva

    Geneva, Canton of Geneva, CH-1211

  • Herzklinik Bodensee am Weinberg AG

    Kreuzlingen, Thurgau, 8280

  • Cardiocentro Ticino

    Lugano, Canton Ticino, 6900

  • Kantonsspital St. Gallen

    Sankt Gallen, Canton of St. Gallen, CH-9007

Other trials in Switzerland

Austria3 sites

  • Krankenhaus der Barmherzigen Schwestern

    Linz, 4010

  • Univ. Klinik f. Innere Medizin II

    Vienna, 1090

  • Wilhelminenspital

    Vienna, 1171

Other trials in Austria

Sweden2 sites

  • Universitetetssjukhuset Umea

    Umeå, SE-901-85

  • Uppsala University Hospital

    Uppsala

Other trials in Sweden

About this study

Official title: 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.

Being tested
Pexelizumab, Placebo infusion

What participants receive

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

  • PexelizumabDrug

    Pexelizumab (2 mg/kg) intravenous , bolus for 10 minutes once

  • Placebo infusionDrug

    bolus infusion over a 10 minute period once

Study groups in NCT00091637
Study groupRoleWhat they receive
1Placebo comparatorPlacebo infusion
Receives: Drug: Placebo infusion
2ExperimentalPexelizumab infusion
Receives: Drug: Pexelizumab

What is being measured

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

  1. Reduction of all causes of mortality

    Measured: day 30

Timeline

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

  1. First posted16 Sep 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionMay 2007
  4. Study completionMay 2007

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
5,745 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00091637
Sponsor's protocol ID
2003056
Status last verified
Nov 2023
First submitted
14 Sep 2004
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 24176448

  • 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.

    PubMed 23549644

  • 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.

    PubMed 23453104

  • 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.

    PubMed 23351826

  • 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.

    PubMed 22814783

  • 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.

    PubMed 22795281

  • 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.

    PubMed 22589297

  • 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.

    PubMed 21304097

  • 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.

    PubMed 20501476

  • 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.

    PubMed 20435202

  • 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.

    PubMed 20129531

  • 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.

    PubMed 20089518

  • 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.

    PubMed 19853693

  • 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.

    PubMed 19389560

  • 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.

    PubMed 18779444

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pexelizumab in people with Acute Myocardial Infarction, run by Procter and Gamble at 349 sites in 17 countries.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 349 sites in United States, Germany, Australia, Czechia, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

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

What does the primary outcome measure?

Reduction of all causes of mortality (time frame: day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00091637, which also lists 16 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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