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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00091637
Other study ID # 2003056
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2004
Est. completion date May 2007

Study information

Verified date November 2023
Source Procter and Gamble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. This study will test the safety and efficacy of a novel complement inhibitor, pexelizumab to reduce mortality at 30 days.


Recruitment information / eligibility

Status Completed
Enrollment 5745
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
Pexelizumab
Pexelizumab (2 mg/kg) intravenous , bolus for 10 minutes once
Placebo infusion
bolus infusion over a 10 minute period once

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Flinders Medical Centre Bedford Park South Australia
Australia Austin Hospital Box Hill Victoria
Australia Box Hill Hospital Box Hill Victoria
Australia Prince Charles Hospital Chermside Queensland
Australia Monash Medical Centre Clayton Victoria
Australia Concord Hospital Concord New South Wales
Australia Townsville Hospital Douglas Queensland
Australia Fremantle Hospital Fremantle Western Australia
Australia Canberra Hospital Garran Australian Capital Territory
Australia Gosford Hospital Gosford New South Wales
Australia St. George Hospital Kogarah New South Wales
Australia Liverpool Hospital Liverpool New South Wales
Australia Sir Charles Gairdner Hospital Nedlands Western Australia
Australia Royal Melbourne Hospital Parkville Victoria
Australia Royal Perth Hospital Perth Western Australia
Australia Prince of Wales Hospital Randwick New South Wales
Australia Victorian Heart Clinic Richmond Victoria
Australia Royal North Shore Hospital St. Leonards New South Wales
Australia The Queen Elizabeth Hospital Woodville South South Australia
Australia Princess Alexandra Hospital Wooloong Abba Queensland
Austria Krankenhaus der Barmherzigen Schwestern Linz
Austria Univ. Klinik f. Innere Medizin II Wien
Austria Wilhelminenspital Wien
Belgium AZ Middelheim Antwerpen
Belgium ZOL Campus Sint-Jan Genk Limburg
Belgium U.Z. Gasthuisberg Leuven Brabant
Belgium CHR de la Citadelle Liege
Belgium Helig Hartziekenhuis Roeselare Vlaanderen
Canada Foothills Medical Centre Calgary Alberta
Canada University of Alberta Hospital Edmonton Alberta
Canada Hamilton General Hospital Hamilton Ontario
Canada Trillium Health Center Mississauga Ontario
Canada Centre Hospitale de'Universite de Montreal (Pav Notre-Dame)_ Montreal Quebec
Canada Hopital Sacre-Coeur de Montreal Montreal Quebec
Canada Montreal Heart Institute/Research Centre Montreal Quebec
Canada Regina General Hospital Regina Saskatchewan
Canada Saint John Regional Hospital - New Brunswick Heart Centre Saint John New Brunswick
Canada Quebec Heart Institute/Laval Hospital Sainte-Foy Quebec
Canada Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec
Canada General Hospital Health Sciences Centre St. John's Newfoundland and Labrador
Canada Sunnybrook & Women's Health Sciences Centre Toronto Ontario
Canada St. Paul's Hospital Vancouver British Columbia
Canada Vancouver General Hospital Vancouver British Columbia
Canada Royal Jubilee Hospital Victoria British Columbia
Czechia I. interni kardioangiologicka klinika, Fakultni nemocnice u Sv. Anny Brno
Czechia Interni kardiologicka klinika, Fakultni nemocnice Brno Brno
Czechia Kardiologicke odd. Nemocnice Ceske Budejovice as Caske Budejovice Ceske Budejovice
Czechia I. Interni klinika, Fakultni nemocnice Hradec Kradec Kralove Hradec Kralove
Czechia Kardiologicke oddeleni, Masarykova nemocnice Labem Usti Nad Labem
Czechia Kardiologicke odd., Krajska neocnice Liberec Liberec
Czechia I. Interni klinika, FN Olomouc Olomouc
Czechia Interni klinika, FNsP Ostrava Ostrava
Czechia Kardio-Troll sro and Krajska nemocnice Pardubice Pardubice
Czechia Kardio-Troll sro and Krajska nemocnice Pardubice Pardubice
Czechia I. Interni klinika, Fakultni nemocnice Plzen Plzen
Czechia II. Interni klinika, Vseobecna fakultni nemocnice Prague
Czechia Kardiocentrum, Fakultni nemocnice Kralovske Vinohrady Prague
Czechia Kardiologicka klinika FN v Motole Prague
Czechia Kardiologicke odd., Nemocnice Na Homoice Prague
Czechia Klinika kardiologie, IKEM Prague 4 Prague
Czechia Kardiocentrum, Nemocnice Podlesi sro Trinec
Czechia Interni klinika, Batova nemocnice Zlin
Denmark Aalborg Sygehus Aalborg Danmark
Denmark Skejby Sygehus Aarhus Danmark
Denmark Amtssygehuset i Gentofte Hellerup Danmark
Denmark Rigshospitalet Kobenhavn Danmark
Denmark Odense Universitets Hospital Odense
France CHRU de Angers Angers
France Clinique Saint Joseph Colmar Cedex
France Cardiologie Hopital Simone Veil Eaubonne-Montmorency
France Centre Hospitalier de Haguenau Haguenau
France CHRU de Nantes Nantes
France Hopital Bichat Paris
France Hopital Lariboisiere Paris
France Hopital a Pitie Salpetriere Paris Cedex 13
France Hopital du Haut Leveque Pessac
France Hopital Pontchaillou Rennes
France CHRU de Rouen Rouen
France Centre Cardiologique du Nord Saint Denis
France CHRU Hautepierre Strasbourg
France Hopital Rangueil Toulouse Cedex 9
France Hopital d'adultes de Brabois (CHU de Nancy) Vandoeuvre les Nancy
Germany Klinikum Augsburg, Stenglinstr. 2. Augsburg Bavaria
Germany Kerckhoff-Klinik Bad Anuheim Bad Nauheim Hessen
Germany Universitatsklinik der Ruhr-Universitat Bochum Bad Oeynhausen
Germany Herzzentrum Bad Segeberg Schleswig Holstein
Germany Vivantes Klinikkum im Friedrichshain Berlin
Germany Vivantes Klinikum am Urban Berlin
Germany Allgemeines Krankenhaus Celle Celle Lower Saxony
Germany Klinikum Coburg Coburg Bavaria
Germany Klinikkum Lippe Detmold North Rhine-Westphalia
Germany St. Johannes Krankenhaus Dortmund Nordhein Westfalen
Germany Herzzentrum Duisburg Duisburg Nordhein Westfalen
Germany Herzzentrum Gottingen Gottingen Lower Saxony
Germany Allgemeines Krankenhaus St. Georg Hamburg
Germany Universitatsklinikum Hamburg-Eppendorf Hamburg
Germany Klinik fur Innere Medizin 1 Jena Thuringia
Germany Stadt. Kliniken Kassel Kassel Hessen
Germany Kliniken der Stadt Koln Koln Nordrhein Westfalen
Germany Herz-Zentrum Bad Krozingen Krozingen Wurrtemberg
Germany Universitatsklinik Lubeck Lubeck Schleswig-Holstein
Germany Klinikkum Ludwigshafen Ludwigshafen Rhineland-Palatinate
Germany Universitatsklinikum Mannheim Mannheim Baden-Wurttemberg
Germany Stadt Krankenhaus Muenchen-Bogenhausen Munchen Bavaria
Germany Helios Klinikum Wuppertal GmbH Wuppertal Nordrhein Westfalen
Italy A.O. SS. Antonio e Biagio e Cesare Arrigo Alessandria
Italy Policlinico Sant'Orsola-Malpighi Bologna
Italy Ospedale Centrale di Bolzano Bolzano
Italy A.O. Spedali di Civili Brescia
Italy Presidio Ospedaliero di Cittadella Cittadella Padova
Italy A.O. della Regione Lombardia Presidio Ospedaliero Sant'Anna Como
Italy Ospedale Alessandro Manzoni Lecco
Italy Azienda Ospedaliera Carlo Poma Mantova
Italy Azienda Ospedaliera di Parma - Ospedale Maggiore Parma
Italy Policlinico San Matteo - I.R.C.C.S. Pavia
Italy A. O. S. Salvatore Pesaro
Italy U.O. Cardiologia Reggio Nell Emilia Reggio Emilla
Italy Osepdale degli Intermi Rimni
Italy AO S. Camillo Forlanini Roma
Italy Centro E Malan San Donato Milanese Milano
Italy Cardiologia Universitaria Torino
Italy Ospedale S. Maria di Ca'Foncello Treviso
Netherlands Medeisch Centrum Alkmaar Alkmaar NH
Netherlands OLVG Amsterdam NH
Netherlands VUMC Amsterdam NH
Netherlands Catharina Hospital Eindhovenb BR
Netherlands Academic Hospital Maastricht Maastricht LI
Netherlands Sint Antonius Hospital Nieuwegein UT
Netherlands Erasmus Medical Centre Rotterdam ZH
Netherlands Medisch Centrum Rijnmond-Zuid Rotterdam ZH
Netherlands University Medical Center Utrecht Ultrecht UT
Netherlands Isla Klinieken Location De Weezenlanden Zwolle OV
New Zealand Auckland City Hospital Auckland
New Zealand Christchurch Hospital Christchurch Canterbury
New Zealand Dunedin Hospital Dunedin Otago
New Zealand Waikato Hospital Hamilton Waikoto
New Zealand Wellington Hospital Wellington
Poland I Klinika Kardiologii Katowice - Ochojec
Poland Klinika Chorob Serca i Naczyn Krakow
Poland II Katedra i Klinika Kardiologii Lodz
Poland I Klinika Choroby Wiencowej Warszawa
Poland SPZOZ Dolnoslaski Szpital Specjalistyczny Wroclaw
Portugal Hospital Garcia de Orta - Servico de Cardiologia Almada Lisboa
Portugal H. Fernando da Fonesca Amadora
Portugal Hospital Santa Cruz Carnaxide Lisboa
Portugal Hospitals da Universidade de Coimbra Coimbra
Portugal H. Santa Maria Lisboa
Portugal Hospital Curry Cabral Lisboa
Portugal Hospital Sao Joao - Servico de Cardiologia Porto
Portugal Centro Hospitalar de Vila Nova de Gala Vila Nova De Gala
Spain Hospital General Universitario de Alicante Alicante
Spain Hospital Clinic i Provincial Barcelona
Spain Hospital Virgen da la Arrixaca El Palmar Murcia
Spain Ciutat Sanitaria i Universitaria de Bellvitge L'Hospitalet de Llobregat Barcelona
Spain Hospital de Leon Leon
Spain Hospital Clinico San Carlos Madrid
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Puerta de Hierro Madrid
Spain Hospital Clinico Universitario Virgen de la Victoria Malaga
Spain Hospital de Navarra Pamplona Navarra
Spain Hopspital Virgen del Rocio Sevilla
Sweden Universitetetssjukhuset Umea Umea
Sweden Uppsala University Hospital Uppsala
Switzerland Kantonsspital Basel Bassel
Switzerland University Hospital of Geneva Geneva 14 Geneva
Switzerland Herzklinik Bodensee am Weinberg AG Kreuzlingen Thurgau
Switzerland Cardiocentro Ticino Lugano Ticino
Switzerland Kantonsspital St. Gallen St. Gallen Saint Gallen
United States Akron General Medical Center Akron Ohio
United States Albany Medical Center Albany New York
United States New Mexico Heart Institute Albuquerque New Mexico
United States Inova Alexandria Hospital Alexandria Virginia
United States Lehigh Valley Hospital Allentown Pennsylvania
United States Northwest Texas Healthcare System Amarillo Texas
United States JFK Medical Center Atlantis Florida
United States Seton Medical Center Austin Texas
United States Eastern Maine Medical Center Bangor Maine
United States Highland Park Hospital Bannockburn Illinois
United States Overtake Hospital Medical Center Bellevue Washington
United States St. Charles Medical Center Bend Oregon
United States Brotman Medical Center Beverly Hills California
United States Deaconess Billings Clinic Billings Montana
United States St. Luke's Regional Medical Center Boise Idaho
United States St. Vincent Medical Center Bridgeport Connecticut
United States Monteflore Medical Center Bronx New York
United States Maimonides Medical Center Brooklyn New York
United States Providence Saint Joseph Medical Center Burbank California
United States Lousiana Heart Center Chalmette Louisiana
United States Presbyterian Hospital Charlotte North Carolina
United States Universitiy of Virginia Health Science Center Charlottesville Virginia
United States Bethesda North Hospital Cincinnati Ohio
United States The University Hospital Cincinnati Ohio
United States VAMC Cincinnati Cincinnati Ohio
United States Morton Plant Hospital Clearwater Florida
United States Cleveland Clinic Foundation Cleveland Ohio
United States University Hospitals of Cleveland Cleveland Ohio
United States Palmetto Richland Memorial Hospital Columbia South Carolina
United States Sisters of Charity Providence Hospitals Columbia South Carolina
United States University of Missouri Health Sciences Center Columbia Missouri
United States MidWest Cardiology Research Foundation Columbus Ohio
United States Mercy Hospital Coon Rapids Minnesota
United States Dallas Medical Center Dallas Texas
United States Medical City Dallas Dallas Texas
United States Parkland Health & Hospital System Dallas Texas
United States Presbyterian Hospital of Dallas Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States Genesis Medical Center Davenport Pennsylvania
United States Oakwood Hospital and Medical Center Dearborn Michigan
United States University of Colorado Hospital Denver Colorado
United States Iowa Heart Des Moines Iowa
United States Henry Ford Hospital Detroit Michigan
United States Sinai-Grace Hospital Detroit Michigan
United States St. Mary's Duluth Clinic Health System Duluth Minnesota
United States Duke University Health Systems Durham North Carolina
United States Fairview Southdale Hospital Edina Minnesota
United States Trinitas Hospital Elizabeth New Jersey
United States Hamot Medical Center Erie Pennsylvania
United States Palomar Medical Center Escondido California
United States St. Joseph's Regional Medical Center Fair Lawn New Jersey
United States University of Connecticut Health Center Farmington Connecticut
United States North Ridge Medical Center Fort Lauderdale Florida
United States Brooke Army Medical Center Fort Sam Houston Texas
United States Sparks Regional Medical Center Fort Smith Arkansas
United States Spectrum Health Grand Rapids Michigan
United States Moses Cone Hospital/LeBauer Healthcare Greensboro North Carolina
United States Pitt County Memorial Hospital Greenville North Carolina
United States Rockingham Memorial Hospital Harrisonburg Virginia
United States Ingalls Hospital Harvey Illinois
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
United States High Point Regional Health System High Point North Carolina
United States Ben Taub General Hospital Houston Texas
United States Houston Northwest Medical Center Houston Texas
United States Memorial Hermann Hospital Houston Texas
United States Michael E. DeBakey VA Medical Center Houston Texas
United States Huntsville Hospital Huntsville Alabama
United States Community Hospital South Indianapolis Indiana
United States Methodist Hospital Indianapolis Indiana
United States The Indiana Heart Hospital Indianapolis Indiana
United States VAMC Indianapolis Indiana
United States Jackson-Madison County General Hospital Jackson Tennessee
United States St. Luke's Hospital Jacksonville Florida
United States Wilson Memorial Medical Center Johnson City New York
United States Borgess Medical Center Kalamazoo Michigan
United States Wellmont Holston Valley Medical Center Kingsport Tennessee
United States Baptist Hospital of East Tennessee Knoxville Tennessee
United States Fort Sanders Rgional Medical Center Knoxville Tennessee
United States Franciscan Skemp Healthcare La Crosse Wisconsin
United States Lousiana Heart Hospital Lacombe Louisiana
United States Lancaster General Hospital Lancaster Pennsylvania
United States Sunrise Hospital Las Vegas Nevada
United States Central Baptist Hospital Lexington Kentucky
United States University of Kentucky Lexington Kentucky
United States St. Elizabeth Medical Center Lincoln Nebraska
United States Arkansas State Hospital Little Rock Arkansas
United States Advocate Good Samaritan Lombard Illinois
United States Elmhurst Hospital Lombard Illinois
United States Los Angeles Community Hospital Los Angeles California
United States Baptist Hospital East Louisville Kentucky
United States The Jewish Hospital Louisville Kentucky
United States Covenant Medical Center Lubbock Texas
United States Lynchburg General Hospital Lynchburg Virginia
United States Med Central Mansfield Mansfield Ohio
United States Health First Holmes Regional Medical Center Melbourne Florida
United States Midwest Regional Medical Center Midwest City Oklahoma
United States Froedtert Hospital Milwaukee Wisconsin
United States Winthrop University Hospital Mineola New York
United States Abbott Northwestern Hospital Minneapolis Minnesota
United States North Memorial Medical Center Minneapolis Minnesota
United States Trinity Hospital Minot North Dakota
United States Memorial Medical Center Modesto California
United States Trinity Medical Center Moline Illinois
United States West Virginia University Hospital Morgantown West Virginia
United States Skagit Valley Hospital Mount Vernon Washington
United States Munster Community Hospital Munster Indiana
United States Cottonwood Hospital Murray Utah
United States Mercy General Health Partners Muskegon Michigan
United States Centennial Medical Center Nashville Tennessee
United States Yale - New Haven New Haven Connecticut
United States MCLNO at New Orleans University Campus New Orleans Louisiana
United States Tulane University Hospital and Clinic New Orleans Louisiana
United States Bellevue Hospital Center New York New York
United States St. Vincent's Catholic Medical Center New York New York
United States Methodist Medical Center Oak Ridge Tennessee
United States Integris Baptist Medical Center, Inc. Oklahoma City Oklahoma
United States Oklahoma Heart Hospital Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States VA Medical Center Oklahoma City Oklahoma
United States Florida Heart Hospital Orlando Florida
United States Saint Francis Medical Center Peoria Illinois
United States Northern Michigan Hospital Petoskey Michigan
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Temple University Hospital Philadelphia Pennsylvania
United States Mayo Clinic Hospital Phoenix Arizona
United States North Phoenix Heart Center Phoenix Arizona
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States Jefferson Regional Medical Center Pittsburgh Pennsylvania
United States VA Pittsburgh Healthcare System Pittsburgh Pennsylvania
United States Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States St. Joseph Mercy-Oakland Pontiac Michigan
United States Maine Medical Center Portland Maine
United States Providence Portland Medical Center Portland Oregon
United States Vassar Brothers Medical Center Poughkeepsie New York
United States Rhode Island Hospital Providence Rhode Island
United States Rapid City Regional Hospital Rapid City South Dakota
United States Herrico Doctors' Hospital - Forest Richmond Virginia
United States Rochester General Hospital Rochester New York
United States Saint Mary Hospital Rochester Minnesota
United States Trinity Medical Center Rock Island Illinois
United States William Beaumont Hospital Royal Oak Michigan
United States Sutter Memorial Hospital Sacramento California
United States Covenant Medical Center Saginaw Michigan
United States Saint Mary Medical Center Saginaw Michigan
United States St. Cloud Hospital Saint Cloud Minnesota
United States Barnes St. Peters Hospital Saint Louis Missouri
United States St. Louis University Hospital Saint Louis Missouri
United States Methodist Hospital Saint Louis Park Minnesota
United States Health East St. Joseph Hospital Saint Paul Minnesota
United States Northeast Baptist Hospital San Antonio Texas
United States South Texas Veterans Health Care System Audie L. Murphy Division San Antonio Texas
United States University of CA, San Diego Medical San Diego California
United States Sutter Medical Center of Santa Rosa Santa Rosa California
United States Sarasota Memorial Hospital Sarasota Florida
United States Harborview Medical Center Seattle Washington
United States Heart Hospital of South Dakota Sioux Falls South Dakota
United States Providence Hospital Southfield Michigan
United States St. John's Hospital Springfield Missouri
United States SUNY - Upstate Medical University Syracuse New York
United States MultiCare Medical Center (Tacoma General Hospital) Tacoma Washington
United States St. Joseph Medical Center Tacoma Washington
United States University Community Hospital Tampa Florida
United States Scott & White Memorial Hospital Temple Texas
United States St. Joseph Medical Center Towson Maryland
United States William Beaumont Hospital Troy Michigan
United States Northwest Medical Center Tucson Arizona
United States East Texas Medical Center Tyler Texas
United States Trinity Mother Frances Hospital Tyler Texas
United States Providence Holy Cross Medical Center Valencia California
United States Citizens Medical Center Victoria Texas
United States Detar Hospital Victoria Texas
United States Sentara Virginia Beach General Hospital Virginia Beach Virginia
United States Harper University Hospital Warren Michigan
United States George Washington University Hospital Washington District of Columbia
United States Waukesha Memorial Hospital Waukesha Wisconsin
United States The Chester County Hospital West Chester Pennsylvania
United States Via Christi Reginal Medical Center Wichita Kansas
United States Winchester Medical Center Winchester Virginia
United States York Hospital York Pennsylvania
United States Genesis Healthcare System Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
Procter and Gamble

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Italy,  Netherlands,  New Zealand,  Poland,  Portugal,  Spain,  Sweden,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of all causes of mortality day 30
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