NCT00091637

Brief 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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
5,745

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2004

Typical duration for phase_3

Geographic Reach
16 countries

328 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2004

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

3.1 years

First QC Date

September 14, 2004

Last Update Submit

November 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction of all causes of mortality

    day 30

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo infusion

Drug: Placebo infusion

2

EXPERIMENTAL

Pexelizumab infusion

Drug: Pexelizumab

Interventions

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

2

bolus infusion over a 10 minute period once

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (349)

Huntsville Hospital

Huntsville, Alabama, 35801, United States

Location

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

North Phoenix Heart Center

Phoenix, Arizona, United States

Location

Northwest Medical Center

Tucson, Arizona, 85741, United States

Location

Sparks Regional Medical Center

Fort Smith, Arkansas, 72901, United States

Location

Arkansas State Hospital

Little Rock, Arkansas, 72211, United States

Location

Brotman Medical Center

Beverly Hills, California, 90230, United States

Location

Providence Saint Joseph Medical Center

Burbank, California, 91505, United States

Location

Palomar Medical Center

Escondido, California, 92025, United States

Location

Los Angeles Community Hospital

Los Angeles, California, 90033, United States

Location

Memorial Medical Center

Modesto, California, 48201, United States

Location

Sutter Memorial Hospital

Sacramento, California, 95825, United States

Location

University of CA, San Diego Medical

San Diego, California, 92103-8784, United States

Location

Sutter Medical Center of Santa Rosa

Santa Rosa, California, 95403, United States

Location

Providence Holy Cross Medical Center

Valencia, California, 91355, United States

Location

University of Colorado Hospital

Denver, Colorado, 80262, United States

Location

St. Vincent Medical Center

Bridgeport, Connecticut, 06606, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030-2202, United States

Location

Yale - New Haven

New Haven, Connecticut, 06520, United States

Location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

North Ridge Medical Center

Fort Lauderdale, Florida, 33308, United States

Location

St. Luke's Hospital

Jacksonville, Florida, 32224, United States

Location

Health First Holmes Regional Medical Center

Melbourne, Florida, 32001, United States

Location

Florida Heart Hospital

Orlando, Florida, 32803, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

University Community Hospital

Tampa, Florida, 33613, United States

Location

St. Luke's Regional Medical Center

Boise, Idaho, 63704, United States

Location

Highland Park Hospital

Bannockburn, Illinois, 60015, United States

Location

Ingalls Hospital

Harvey, Illinois, 80426, United States

Location

Advocate Good Samaritan

Lombard, Illinois, 60148, United States

Location

Elmhurst Hospital

Lombard, Illinois, 60148, United States

Location

Trinity Medical Center

Moline, Illinois, 61265, United States

Location

Saint Francis Medical Center

Peoria, Illinois, 61603, United States

Location

Trinity Medical Center

Rock Island, Illinois, 61201, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

VAMC

Indianapolis, Indiana, 46202, United States

Location

Community Hospital South

Indianapolis, Indiana, 46227, United States

Location

The Indiana Heart Hospital

Indianapolis, Indiana, 56250, United States

Location

Munster Community Hospital

Munster, Indiana, 46321, United States

Location

Iowa Heart

Des Moines, Iowa, 50314, United States

Location

Via Christi Reginal Medical Center

Wichita, Kansas, 67214, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

University of Kentucky

Lexington, Kentucky, 40536-0200, United States

Location

The Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Baptist Hospital East

Louisville, Kentucky, 40207, United States

Location

Lousiana Heart Center

Chalmette, Louisiana, 70043, United States

Location

Lousiana Heart Hospital

Lacombe, Louisiana, 70445, United States

Location

MCLNO at New Orleans University Campus

New Orleans, Louisiana, 70112, United States

Location

Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

St. Joseph Medical Center

Towson, Maryland, 21204, United States

Location

Oakwood Hospital and Medical Center

Dearborn, Michigan, 48123, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Sinai-Grace Hospital

Detroit, Michigan, 48235, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49048, United States

Location

Mercy General Health Partners

Muskegon, Michigan, 49444, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

St. Joseph Mercy-Oakland

Pontiac, Michigan, 48341-2982, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Covenant Medical Center

Saginaw, Michigan, 48601, United States

Location

Saint Mary Medical Center

Saginaw, Michigan, 48601, United States

Location

Providence Hospital

Southfield, Michigan, 48075, United States

Location

William Beaumont Hospital

Troy, Michigan, 48085, United States

Location

Harper University Hospital

Warren, Michigan, 48201, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

St. Mary's Duluth Clinic Health System

Duluth, Minnesota, 55805, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

North Memorial Medical Center

Minneapolis, Minnesota, 55422, United States

Location

Saint Mary Hospital

Rochester, Minnesota, 55902, United States

Location

St. Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

Methodist Hospital

Saint Louis Park, Minnesota, 55426, United States

Location

Health East St. Joseph Hospital

Saint Paul, Minnesota, 55102, United States

Location

University of Missouri Health Sciences Center

Columbia, Missouri, 65212, United States

Location

St. John's Hospital

Springfield, Missouri, 65807, United States

Location

St. Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Barnes St. Peters Hospital

St Louis, Missouri, 63122, United States

Location

Deaconess Billings Clinic

Billings, Montana, 59101, United States

Location

St. Elizabeth Medical Center

Lincoln, Nebraska, 68510, United States

Location

Sunrise Hospital

Las Vegas, Nevada, 89109, United States

Location

Trinitas Hospital

Elizabeth, New Jersey, 07202, United States

Location

St. Joseph's Regional Medical Center

Fair Lawn, New Jersey, 07410, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

Albany Medical Center

Albany, New York, 12211, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Wilson Memorial Medical Center

Johnson City, New York, 13790, United States

Location

Winthrop University Hospital

Mineola, New York, 11504, United States

Location

St. Vincent's Catholic Medical Center

New York, New York, 10011, United States

Location

Bellevue Hospital Center

New York, New York, 10016, United States

Location

Vassar Brothers Medical Center

Poughkeepsie, New York, 12601, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

SUNY - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Monteflore Medical Center

The Bronx, New York, 10467, United States

Location

Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

Duke University Health Systems

Durham, North Carolina, 27705, United States

Location

Moses Cone Hospital/LeBauer Healthcare

Greensboro, North Carolina, 27401, United States

Location

Pitt County Memorial Hospital

Greenville, North Carolina, 27834, United States

Location

High Point Regional Health System

High Point, North Carolina, 27262, United States

Location

Trinity Hospital

Minot, North Dakota, 58701, United States

Location

Akron General Medical Center

Akron, Ohio, 44307, United States

Location

VAMC Cincinnati

Cincinnati, Ohio, 45220, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

The University Hospital

Cincinnati, Ohio, 45267, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44103, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MidWest Cardiology Research Foundation

Columbus, Ohio, 43214, United States

Location

Med Central Mansfield

Mansfield, Ohio, 44906, United States

Location

Genesis Healthcare System

Zanesville, Ohio, 43701, United States

Location

Midwest Regional Medical Center

Midwest City, Oklahoma, 73110, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

VA Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Integris Baptist Medical Center, Inc.

Oklahoma City, Oklahoma, 73112, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

St. Charles Medical Center

Bend, Oregon, 97701, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18105, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2160, United States

Location

Genesis Medical Center

Davenport, Pennsylvania, 58803, United States

Location

Hamot Medical Center

Erie, Pennsylvania, 16550, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Jefferson Regional Medical Center

Pittsburgh, Pennsylvania, 15025, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15215, United States

Location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

The Chester County Hospital

West Chester, Pennsylvania, 19380, United States

Location

York Hospital

York, Pennsylvania, 17405, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Palmetto Richland Memorial Hospital

Columbia, South Carolina, 29203, United States

Location

Sisters of Charity Providence Hospitals

Columbia, South Carolina, 29204, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57719, United States

Location

Heart Hospital of South Dakota

Sioux Falls, South Dakota, 57108, United States

Location

Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Fort Sanders Rgional Medical Center

Knoxville, Tennessee, 37916, United States

Location

Baptist Hospital of East Tennessee

Knoxville, Tennessee, 37920, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Methodist Medical Center

Oak Ridge, Tennessee, 37830, United States

Location

Northwest Texas Healthcare System

Amarillo, Texas, 79106, United States

Location

Seton Medical Center

Austin, Texas, 78705, United States

Location

Presbyterian Hospital of Dallas

Dallas, Texas, 57231, United States

Location

Medical City Dallas

Dallas, Texas, 75230, United States

Location

Dallas Medical Center

Dallas, Texas, 75390, United States

Location

Parkland Health & Hospital System

Dallas, Texas, 75390, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Houston Northwest Medical Center

Houston, Texas, 77090, United States

Location

Covenant Medical Center

Lubbock, Texas, 79410, United States

Location

Northeast Baptist Hospital

San Antonio, Texas, 78217, United States

Location

South Texas Veterans Health Care System Audie L. Murphy Division

San Antonio, Texas, 78258, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

East Texas Medical Center

Tyler, Texas, 75701, United States

Location

Trinity Mother Frances Hospital

Tyler, Texas, 75701, United States

Location

Citizens Medical Center

Victoria, Texas, 77901, United States

Location

Detar Hospital

Victoria, Texas, 77901, United States

Location

Cottonwood Hospital

Murray, Utah, 84107, United States

Location

Inova Alexandria Hospital

Alexandria, Virginia, 22306, United States

Location

Universitiy of Virginia Health Science Center

Charlottesville, Virginia, 22908, United States

Location

Rockingham Memorial Hospital

Harrisonburg, Virginia, 22801, United States

Location

Lynchburg General Hospital

Lynchburg, Virginia, 24501, United States

Location

Herrico Doctors' Hospital - Forest

Richmond, Virginia, United States

Location

Sentara Virginia Beach General Hospital

Virginia Beach, Virginia, 23454, United States

Location

Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

Overtake Hospital Medical Center

Bellevue, Washington, 98004, United States

Location

Skagit Valley Hospital

Mount Vernon, Washington, 98274, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MultiCare Medical Center (Tacoma General Hospital)

Tacoma, Washington, 98405, United States

Location

St. Joseph Medical Center

Tacoma, Washington, 98405, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, 26506-9157, United States

Location

Franciscan Skemp Healthcare

La Crosse, Wisconsin, 54601, United States

Location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Concord Hospital

Concord, New South Wales, 2137, Australia

Location

Gosford Hospital

Gosford, New South Wales, 2250, Australia

Location

St. George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Townsville Hospital

Douglas, Queensland, 4814, Australia

Location

Princess Alexandra Hospital

Wooloong Abba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

The Queen Elizabeth Hospital

Woodville South, South Australia, 5011, Australia

Location

Austin Hospital

Box Hill, Victoria, 3084, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3162, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Victorian Heart Clinic

Richmond, Victoria, 3121, Australia

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Krankenhaus der Barmherzigen Schwestern

Linz, 4010, Austria

Location

Univ. Klinik f. Innere Medizin II

Vienna, 1090, Austria

Location

Wilhelminenspital

Vienna, 1171, Austria

Location

U.Z. Gasthuisberg

Leuven, Brabant, 3000, Belgium

Location

Helig Hartziekenhuis

Roeselare, Flanders, 8800, Belgium

Location

ZOL Campus Sint-Jan

Genk, Limburg, 3600, Belgium

Location

AZ Middelheim

Antwerp, 2020, Belgium

Location

CHR de la Citadelle

Liège, 4000, Belgium

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2W8, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1L8, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Royal Jubilee Hospital

Victoria, British Columbia, V8R 4R2, Canada

Location

Saint John Regional Hospital - New Brunswick Heart Centre

Saint John, New Brunswick, E2L 4L2, Canada

Location

General Hospital Health Sciences Centre

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

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Trillium Health Center

Mississauga, Ontario, L58 2P7, Canada

Location

Sunnybrook & Women's Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Montreal Heart Institute/Research Centre

Montreal, Quebec, H1T 1C8, Canada

Location

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

Montreal, Quebec, H2L 4M1, Canada

Location

Hopital Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Quebec Heart Institute/Laval Hospital

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

Location

Kardiologicke odd. Nemocnice Ceske Budejovice as

Caske Budejovice, Ceske Budejovice, 370 878, Czechia

Location

I. Interni klinika, Fakultni nemocnice Hradec

Kradec Kralove, Hradec Kralove, 500 05, Czechia

Location

Klinika kardiologie, IKEM

Prague, Prague, 14021, Czechia

Location

Kardiologicke oddeleni, Masarykova nemocnice

Labem, Usti Nad Labem, 401 13, Czechia

Location

Interni kardiologicka klinika, Fakultni nemocnice Brno

Brno, 625 00, Czechia

Location

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

Brno, 656 91, Czechia

Location

Kardiologicke odd., Krajska neocnice Liberec

Liberec, 460 63, Czechia

Location

I. Interni klinika, FN Olomouc

Olomouc, 775-20, Czechia

Location

Interni klinika, FNsP Ostrava

Ostrava, 708 52, Czechia

Location

Kardio-Troll sro and Krajska nemocnice Pardubice

Pardubice, 532 03, Czechia

Location

Kardio-Troll sro and Krajska nemocnice Pardubice

Pardubice, 53203, Czechia

Location

I. Interni klinika, Fakultni nemocnice Plzen

Pilsen, 304 60, Czechia

Location

Kardiocentrum, Fakultni nemocnice Kralovske Vinohrady

Prague, 10034, Czechia

Location

II. Interni klinika, Vseobecna fakultni nemocnice

Prague, 128 08, Czechia

Location

Kardiologicke odd., Nemocnice Na Homoice

Prague, 150 30, Czechia

Location

Kardiologicka klinika FN v Motole

Prague, 15006, Czechia

Location

Kardiocentrum, Nemocnice Podlesi sro

Třinec, 739 61, Czechia

Location

Interni klinika, Batova nemocnice

Zlín, 462 75, Czechia

Location

Aalborg Sygehus

Aalborg, Danmark, 9100, Denmark

Location

Skejby Sygehus

Aarhus, Danmark, 8200, Denmark

Location

Rigshospitalet

Copenhagen, Danmark, DK-2100, Denmark

Location

Amtssygehuset i Gentofte

Hellerup, Danmark, 2900, Denmark

Location

Odense Universitets Hospital

Odense, 5000, Denmark

Location

CHRU de Angers

Angers, 49100, France

Location

Clinique Saint Joseph

Colmar, 66027, France

Location

Cardiologie Hopital Simone Veil

Eaubonne-Montmorency, 95601, France

Location

Centre Hospitalier de Haguenau

Haguenau, 67504, France

Location

CHRU de Nantes

Nantes, 44000, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Hopital Bichat

Paris, 75018, France

Location

Hopital a Pitie Salpetriere

Paris, 75743, France

Location

Hopital du Haut Leveque

Pessac, 33604, France

Location

Hopital Pontchaillou

Rennes, 35000, France

Location

CHRU de Rouen

Rouen, 76000, France

Location

Centre Cardiologique du Nord

Saint-Denis, 93200, France

Location

CHRU Hautepierre

Strasbourg, 67100, France

Location

Hopital Rangueil

Toulouse, 31059, France

Location

Hopital d'adultes de Brabois (CHU de Nancy)

Vandœuvre-lès-Nancy, 54511, France

Location

Universitatsklinikum Mannheim

Mannheim, Baden-Wurttemberg, 66167, Germany

Location

Klinikum Augsburg, Stenglinstr. 2.

Augsburg, Bavaria, 86156, Germany

Location

Klinikum Coburg

Coburg, Bavaria, 96450, Germany

Location

Stadt Krankenhaus Muenchen-Bogenhausen

München, Bavaria, 81925, Germany

Location

Kerckhoff-Klinik Bad Anuheim

Bad Nauheim, Hesse, 61231, Germany

Location

Stadt. Kliniken Kassel

Kassel, Hesse, 34125, Germany

Location

Allgemeines Krankenhaus Celle

Celle, Lower Saxony, 29223, Germany

Location

Herzzentrum Gottingen

Göttingen, Lower Saxony, 37075, Germany

Location

St. Johannes Krankenhaus

Dortmund, Nordhein Westfalen, 44137, Germany

Location

Herzzentrum Duisburg

Duisburg, Nordhein Westfalen, 47137, Germany

Location

Kliniken der Stadt Koln

Cologne, North Rhine-Westphalia, 51109, Germany

Location

Klinikkum Lippe

Detmold, North Rhine-Westphalia, 32756, Germany

Location

Helios Klinikum Wuppertal GmbH

Wuppertal, North Rhine-Westphalia, 42117, Germany

Location

Klinikkum Ludwigshafen

Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

Location

Herzzentrum

Bad Segeberg, Schleswig-Holstein, 23795, Germany

Location

Universitatsklinik Lubeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Klinik fur Innere Medizin 1

Jena, Thuringia, 07740, Germany

Location

Herz-Zentrum Bad Krozingen

Krozingen, Wurrtemberg, 79189, Germany

Location

Universitatsklinik der Ruhr-Universitat Bochum

Bad Oeynhausen, 32545, Germany

Location

Vivantes Klinikkum im Friedrichshain

Berlin, 10249, Germany

Location

Vivantes Klinikum am Urban

Berlin, 10967, Germany

Location

Allgemeines Krankenhaus St. Georg

Hamburg, 20099, Germany

Location

Universitatsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Centro E Malan

San Donato Milanese, Milano, 20097, Italy

Location

Presidio Ospedaliero di Cittadella

Cittadella, Padova, 35013, Italy

Location

U.O. Cardiologia

Reggio Emilia, Reggio Emilla, 42100, Italy

Location

Osepdale degli Intermi

Rimni, Rimni, 47900, Italy

Location

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

Alessandria, 15100, Italy

Location

Policlinico Sant'Orsola-Malpighi

Bologna, 40128, Italy

Location

Ospedale Centrale di Bolzano

Bolzano, 39100, Italy

Location

A.O. Spedali di Civili

Brescia, 25123, Italy

Location

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

Como, 22100, Italy

Location

Ospedale Alessandro Manzoni

Lecco, 23900, Italy

Location

Azienda Ospedaliera Carlo Poma

Mantova, 46100, Italy

Location

Azienda Ospedaliera di Parma - Ospedale Maggiore

Parma, 43100, Italy

Location

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

Pavia, 27100, Italy

Location

A. O. S. Salvatore

Pesaro, 46100, Italy

Location

AO S. Camillo Forlanini

Roma, 00152, Italy

Location

Cardiologia Universitaria

Torino, 10126, Italy

Location

Ospedale S. Maria di Ca'Foncello

Treviso, 31100, Italy

Location

Catharina Hospital

Eindhovenb, BR, 5623 EJ, Netherlands

Location

Academic Hospital Maastricht

Maastricht, LI, 6229 HX, Netherlands

Location

Medeisch Centrum Alkmaar

Alkmaar, North Holland, 1800 AM, Netherlands

Location

VUMC

Amsterdam, North Holland, 1081 HV, Netherlands

Location

OLVG

Amsterdam, North Holland, 1091 HD, Netherlands

Location

Isla Klinieken Location De Weezenlanden

Zwolle, Overijssel, 8011 JW, Netherlands

Location

Erasmus Medical Centre

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Medisch Centrum Rijnmond-Zuid

Rotterdam, South Holland, 3075 EA, Netherlands

Location

Sint Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

University Medical Center Utrecht

Ultrecht, Utrecht, 3584 CX, Netherlands

Location

Christchurch Hospital

Christchurch, Canterbury, 8001, New Zealand

Location

Dunedin Hospital

Dunedin, Otago, 9001, New Zealand

Location

Waikato Hospital

Hamilton, Waikoto, 2001, New Zealand

Location

Auckland City Hospital

Auckland, 1003, New Zealand

Location

Wellington Hospital

Wellington, 6002, New Zealand

Location

I Klinika Kardiologii

Katowice - Ochojec, 40-635, Poland

Location

Klinika Chorob Serca i Naczyn

Krakow, 31-202, Poland

Location

II Katedra i Klinika Kardiologii

Lodz, 91-347, Poland

Location

I Klinika Choroby Wiencowej

Warsaw, 04-628, Poland

Location

SPZOZ Dolnoslaski Szpital Specjalistyczny

Wroclaw, 50-420, Poland

Location

Hospital Garcia de Orta - Servico de Cardiologia

Almada, Lisbon District, 2801-951 Almada, Portugal

Location

Hospital Santa Cruz

Carnaxide, Lisbon District, 270-134, Portugal

Location

H. Fernando da Fonesca

Amadora, 3700-376 Amadora, Portugal

Location

Hospitals da Universidade de Coimbra

Coimbra, 3000-075 Coimbra, Portugal

Location

Hospital Curry Cabral

Lisbon, 1069-166 Lisboa, Portugal

Location

H. Santa Maria

Lisbon, 1600-190 LISBOA, Portugal

Location

Hospital Sao Joao - Servico de Cardiologia

Porto, 4200-319 Porto, Portugal

Location

Centro Hospitalar de Vila Nova de Gala

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

Location

Ciutat Sanitaria i Universitaria de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Virgen da la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

Hospital de Leon

León, 24008, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Puerta de Hierro

Madrid, 28035, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hopspital Virgen del Rocio

Seville, 41013, Spain

Location

Universitetetssjukhuset Umea

Umeå, SE-901-85, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Kantonsspital Basel

Bassel, Bassel, 4031, Switzerland

Location

University Hospital of Geneva

Geneva, Canton of Geneva, CH-1211, Switzerland

Location

Kantonsspital St. Gallen

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

Location

Cardiocentro Ticino

Lugano, Canton Ticino, 6900, Switzerland

Location

Herzklinik Bodensee am Weinberg AG

Kreuzlingen, Thurgau, 8280, Switzerland

Location

Related Publications (16)

  • 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.

  • 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.

MeSH Terms

Interventions

pexelizumab

Study Officials

  • Thomas G Todaro, MD, JD, FACC

    Procter and Gamble

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2004

First Posted

September 16, 2004

Study Start

April 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations