MICHELANGELO OASIS-6 : Fondaparinux in ST Elevation Myocardial Infarction

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00064428
First received: July 8, 2003
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

The purpose of this research study is to determine the efficacy and safety of fondaparinux (Arixtra) in preventing death and repeat heart attacks and their complications.


Condition Intervention Phase
Myocardial Infarction
ST-elevation Myocardial Infarction
Acute Coronary Syndrome
Acute Myocardial Infarction
Drug: Fondaparinux - UFH indicated
Other: Control - UFH not indicated
Drug: fondaparinux - UFH not indicated
Drug: Control - UFH
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Efficacy Trial Evaluating Fondaparinux Use in a Broad Range of Patients With ST Segment Elevation Acute MI

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Death or recurrent myocardial infarction [ Time Frame: up to day 30 ] [ Designated as safety issue: No ]
    the first occurrence of any component of death (all-cause mortality) or recurrent myocardial infarction

  • Severe hemorrhage [ Time Frame: up to Day 9 ] [ Designated as safety issue: Yes ]
    Severe hemorrhage (modified TIMI criteria)


Secondary Outcome Measures:
  • Death or recurrent myocardial infarction [ Time Frame: up to Day 9, 90 and 180 ] [ Designated as safety issue: No ]
    The first occurrence of any component of the composite of death (all-cause mortality) or recurrent myocardial infarction

  • Death, recurrent myocardial infarction or refractory ischemia [ Time Frame: up to Day 9, 30, 90 and 180 ] [ Designated as safety issue: No ]
    The first occurrence of any component of the composite of death (all-cause mortality), recurrent myocardial infarction or refractory ischemia


Enrollment: 12092
Study Start Date: August 2003
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fondaparinux - UFH not indicated
Subjects with no indication for UFH therapy: 2.5mg od, sc, (1st dose IV) x 8 days or discharge
Drug: fondaparinux - UFH not indicated
2.5mg od, sc (1st dose IV) x 8 days or discharge
Placebo Comparator: Control - UFH not indicated
Subjects with no indication for UFH therapy: Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
Other: Control - UFH not indicated
Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
Experimental: Fondaparinux - UFH indicated
Subjects indicated for UFH: 2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus + 24-48 hr infusion
Drug: Fondaparinux - UFH indicated
2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus x 24-48 hr infusion
Active Comparator: Control - unfractionated heparin
Subjects indicated for UFH: UFH IV bolus +12 IU/kg/hr infusion x 24-48 hr + fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
Drug: Control - UFH
UFH IV bolus +12 IU/kg/hr infusion x 24-48 hr + fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge

Detailed Description:

This is a randomized, double blind, controlled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI randomized within 24 hours of the onset of symptoms. Patients with confirmed STEMI were assigned into one of the following strata, based on local preference: Stratum 1: No indication for UFH; it is generally accepted that patients receiving streptokinase or those not receiving a thrombolytic agent were assigned to this stratum. Stratum 2: Indication for UFH; it is generally accepted that patients receiving a fibrin-specific agent (such as alteplase, reteplase or tenecteplase) or those undergoing primary PCI were assigned to this stratum. Patients who were ineligible for fibrinolysis (e.g. because of late presentation or absolute contra-indication for reperfusion therapy) may fall into either stratum 1 or stratum 2 at investigator's discretion. Following allocation to one of the strata, patients were randomized to fondaparinux or control treatment. Control treatment was dependent on whether the patient was assigned to stratum 1 or stratum 2: Stratum 1: fondaparinux sc* versus fondaparinux-placebo sc for 8 days or until hospital discharge, whichever was earlier. Stratum 2: fondaparinux sc* for 8 days or until hospital discharge, whichever was earlier and UFH-placebo for 24 to 48 hrs (or single bolus injection immediately prior to procedure in case of primary PCI) versus UFH for 24 to 48 hrs (or single bolus injection immediately prior to procedure in case of primary PCI) and fondaparinux-placebo for 8 days or until hospital discharge, whichever was earlier. (*First dose intravenous bolus) Patients were followed up for 6 months

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting or admitted to hospital with: a) signs and symptoms of acute myocardial infarction (AMI) b) able to randomize within 24 hours from symptom onset, and c) definite ECG changes indicating STEMI: persistent ST-elevation (greater than or equal to 0.2 mV in two contiguous precordial leads, or greater than or equal to 0.1 mV in at least two limb leads), or new left bundle branch block, or ECG changes indicating true posterior MI
  • written informed consent

Exclusion criteria:

  • age < 21 years
  • currently receiving an oral anticoagulant agent with an INR > 1.8
  • any contraindication to anticoagulation therapy such as high risk of bleeding or active bleeding
  • hemorrhagic stroke within the last 12 months
  • indication for anticoagulation other than acute coronary syndrome (ACS)
  • pregnant women or women of child-bearing potential who are not using an effective method of contraception
  • co-morbid condition with a life expectancy < 6 months
  • prior enrollment in one of the fondaparinux ACS trials
  • participation in another pharmacotherapeutic study within the prior 30 days or currently receiving an experimental pharmacological agent
  • known allergy to heparin or fondaparinux
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064428

  Hide Study Locations
Locations
United States, Florida
Brevard Cardiology Physicians, PA
Merritt Island, Florida, United States, 32953
Ocala Regional Medical Center
Ocala, Florida, United States
Ocala Research Institute, Inc.
Ocala, Florida, United States
Wuesthoff Hospital
Rockledge, Florida, United States, 32955
United States, Illinois
The University of Chicago Center for Advanced Medicine
Chicago, Illinois, United States
United States, Maine
St. Mary's Regional Medical Center
Lewiston, Maine, United States, 04243
United States, New York
Cardiology Associates, P.C.
Johnson City, New York, United States
Wilson Regional Medical Center of UHSH, Inc.
Johnson City, New York, United States
Crouse Hospital
Syracuse, New York, United States, 13210
United States, Texas
Northwest Texas Healthcare System
Amarillo, Texas, United States
Amarillo Heart Group
Amarillo, Texas, United States
Wilford Hall Medical Center
San Antonio, Texas, United States
Argentina
Clinica Coronel Suarez
Buenos Aires, Argentina
Policlinica Bancaria
Buenos Aires, Argentina
Hospital General de Agudos "Donacion Francisco Santojanni"
Buenos Aires, Argentina
Centro de Educacion Medica e Investigaciones Clinica "Norberto Quirno"
Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, Argentina
Clinica Privada Provincial S.A.
Buenos Aires, Argentina
Hospital Italiano de La Plata
Buenos Aires, Argentina
Clinica Modelo de Moron
Buenos Aires, Argentina
Antartida Instituto Medico
Buenos Aires, Argentina
Corporacion Medica de General San Martin S.A.
Buenos Aires, Argentina
Hospital Frances
Buenos Aires, Argentina
Sanatorio Modelo Quilmes
Buenos Aires, Argentina
Clinica Pivada Milenio S.A.
Buenos Aires, Argentina
Sanatorio Allende
Cordoba, Argentina
Clinica Privada Caraffe
Cordoba, Argentina
Hospital Privado Centro Medico de Cordoba S.A.
Cordoba, Argentina
Hospital "Luis Carlos Lagomaggiore"
Mendoza, Argentina
Hospital San Bernardo
Salta, Argentina
Instituto Cardiovascular San Luis
San Luis, Argentina
Hospital Centro de Salud
San Miguel de Tucuman, Argentina
Instituto de Cardiologia S.R.L.
San Miguel de Tucuman, Argentina
Centro Privado de Cardiologia
San Miguel de Tucuman, Argentina
Sanatorio Medico de Diagnostico y Tratamiento
Santa Fe, Argentina
Instituto Cardiovascular de Rosario
Santa Fe, Argentina
Australia, New South Wales
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia, 2450
Australia, Victoria
Bendigo Hospital
Bendigo, Victoria, Australia, 3550
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Austin Health
Heidelberg, Victoria, Australia, 3084
Central Gippsland Health Service
Sale, Victoria, Australia, 3850
Australia, Western Australia
Heart Research Institute - Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Australia
Lismore Base Hospital
Lismore, Australia
Mackay Base Hospital
Mackay, Australia
Royal North Shore Hospital
St. Leonards, Australia
Austria
Wilhelminen Hospital (Cardiology and Emergency Medicine)
Vienna, Austria, 1160
Belgium
Algemeen Ziekenhuis Middelheim
Antwerpen, Belgium, 2020
Algemeen Ziekenhuis Sint Jan
Brugge, Belgium, 8000
Academic Hospital VUB
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
Centre Hospitalier Regional Hutois
Huy, Belgium, 4500
Sint Augustinuskliniek
Veurne, Belgium, 8630
Brazil
Hospital Vera Cruz
Belo Horizonte, MG, Brazil, 30190-130
Hospital Universitario Evangelico de Curitiba
Curitiba, PR, Brazil, 80730-150
Hospital Pro-Cardiaco S/A
Rio de Janeiro, RJ, Brazil, 22280-000
Hospital Universitario Pedro Ernesto
Rio de Janeiro, RJ, Brazil, 20551-030
Santa Casa de Misericoridia de Pelotas
Pelotas, RS, Brazil, 96015-290
Hospital Sao Francisco - Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, RS, Brazil, 90020-090
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS)
Porto Alegre, RS, Brazil, 90610-000
Hospital Mae de Deus
Porto Alegre, RS, Brazil
Instituto de Cardiologia de Santa Catarina
Sao Jose, SC, Brazil, 88103-460
Hospital e Maternidade Celso Pierro/ PUC Campinas
Campinas, SP, Brazil, 13059-740
Santa Casa de Misericordia de Marilia - Instituto do Coracao
Marilia, SP, Brazil, 17515-000
Instituto de Molestias Cardiovasculares
Sao Jose de Rio Preto, SP, Brazil, 15015-210
Hospital de Base
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Hospital Geral do Grajau
Sao Paulo, SP, Brazil, 04822-320
Hospital Sao Paulo - UNIFESP/EPM
Sao Paulo, SP, Brazil, 04025-002
Instituto Dante Pazzanese de Cardiologia
Sao Paulo, SP, Brazil, 04012-909
Conjunto Hospitalar de Sorocaba
Sorocaba, SP, Brazil, 18031-000
Santa Casa de Belo Horizonte
Belo Horizonte, Brazil
Hospital Socor
Belo Horizonte, Brazil
Hospital Santa Isabel
Blumenau, Brazil
Hospital Santa Rita
Maringa, Brazil
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
Instituto Nacional de Cardiologia Laranjeiras
Rio de Janeiro, Brazil
Hospital Universitario Edgar Santos
Salvador, Brazil
Hospital Portugues
Salvador, Brazil
Instituto do Coracao
Sao Paulo, Brazil
Bulgaria
MHAT - Haskovo
Haskovo, Bulgaria
MHAT - Pleven EAD
Pleven, Bulgaria
MHAT - Plovdiv
Plovdiv, Bulgaria
MHAT Rousse EAD
Rousse, Bulgaria
5th MHAT Sofia
Sofia, Bulgaria
Military Medical Academy
Sofia, Bulgaria
Medical Institute - Central Clinical Base - Ministry of Interior
Sofia, Bulgaria
2nd MHAT - Sofia
Sofia, Bulgaria
MHAT St. Marina
Varna, Bulgaria
Canada, British Columbia
Kelowna General Hospital
Kelowna, British Columbia, Canada
Ridge Meadows Hospital
Maple Ridge, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Canada, Ontario
Hamilton Health Sciences - General Site, Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Henderson Hospital
Hamilton, Ontario, Canada
Niagara Health System - Greater Niagara General Site
Niagara Fall, Ontario, Canada
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada
Chile
Hospital del Salvador
Providencia, Chile
Hospital de Urgencia de la Asistencia Publica
Santiago, Chile
Hospital Barros Luco Trudeau
Santiago, Chile
Hospital Clinico de la Pontificia Unversidad Catolica de Chile
Santiago, Chile
Hospital DIPRECA
Santiago, Chile
Hospital Regional de Temuco
Temuco, Chile
China
Queen Mary Hospital
Hong Kong, China
Croatia
Clinical Hospital Centre Rijeka
Rijeka, Croatia, 51000
Clinical Hospital Split
Split, Croatia, 21000
Clinical Hospital Dubrava
Zagreb, Croatia, 10000
University Hospital Sestre milosrdnice
Zagreb, Croatia, 10000
Clinical Hospital Centre Rebro
Zagreb, Croatia
Czech Republic
FN Brno - Bohunice
Brno, Czech Republic
Nemocnice Ceske Budejovice
Ceske Budejovice, Czech Republic
Nemocnice s ambulantni casti
Kutna Hora, Czech Republic
Krajska nemocnice Liberec
Liberec, Czech Republic
FN Ostrava
Ostrava - Poruba, Czech Republic
Krajska nemocnice Pardubice
Pardubice, Czech Republic
Fakultni nemocnice v Motole
Praha, Czech Republic
Faculty Hospital Kralovske Vinohrady
Praha, Czech Republic
IKEM
Praha, Czech Republic
Nemocnice Slany
Slany, Czech Republic
Nemocnice Trebic
Trebic, Czech Republic
Masarykova nemocnice
Usti nad Labern, Czech Republic
Denmark
Aarhus University Hospital
Aarhus, Denmark, DK-8000
Copenhagen University Hospital
Copenhagen, Denmark, 2100
Centralsygehuset Esbjerg
Esbjerg, Denmark, 6700
Gentofte University Hospital
Hellerup, Denmark, DK-2900
Odense Universitets Hospital
Odense, Denmark, 5000
Estonia
Tartu University Clinics
Tartu, Estonia, 51014
Finland
Central Ostrobothnia Central Hospital
Kokkola, Finland, 67200
Oulu University Hospital
Oulu, Finland
France
Centre Hospitalier de Belfort
Belfort, France
Hopital Jean Minjoz
Besancon, France
Centre Hospitalier Dr Duchenne
Boulogne sur Mer, France
CHU de Caen
Caen, France
Hopital G Montpied
Clermont-Ferrand, France
Hopital Henri Mondor
Creteil, France
Hopital de la SSM
Freyming Merlebach, France
Polyclinique du Bois
Lille, France
Hopital Cardiologique
Lyon, France
Hopital Bon Secours
Metz, France
CHU Pasteur
Nice, France
Cliniques des Franciscaines
Nimes, France
Hopital Bichat
Paris, France
Hospitaux Universitaires de Strasbourg
Strasbourg, France
CHU de Rangueil
Toulouse, France
Hopital Trousseau
Tours, France
Germany
Institut fur Herz-Kreislaufforschung
Bad Rothenfelde, Germany
University of Berlin - Charite of the Humboldt
Berlin, Germany, 10117
Uni-Klinikum Benjamin Franklin, FU Berlin
Berlin, Germany
St. Johannes Hospital Dortmund
Dortmund, Germany
Krankenhaus Dueren
Dueren, Germany
Herzzentrum Duisburg
Duisburg, Germany
Klinikum der Medizinischen Fakultat der Martin-Luther Universitat
Halle, Germany
St. Sixtus Hospital
Haltern, Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hannover, Germany
Medizinische Klinik und Poliklinik, Universitatsklinikum Heidelberg
Heidelberg, Germany
Krankenhaus Heidenheim
Heidenheim, Germany, 89522
Johannes-Gutenberg-Universitaet Mainz
Mainz, Germany, D-55101
Abteilung Innere Medizin II
Monchengladbach, Germany
Klinikum der Universitat Munchen
Munchen, Germany
Klinikum Nurnberg
Nurnberg, Germany, 90471
Staedtische Kliniken Offenbach
Offenbach, Germany
Knappschafts Krankenhaus
Recklinghausen, Germany
Stadtkrankenhaus Russelsheim
Russelsheim, Germany
Medizinische Klink II - Klinikum Saarbrucken
Saarbrucken, Germany, 66119
St.-Marien-Krankenhaus Siegen
Siegen, Germany
Kreiskrankenhaus Waldbrol
Waldbrol, Germany
St. Josefs Hospital
Wiesbaden, Germany
HSK, Dr.-Horst-Schmidt-Kliniken GmbH
Wieshaden, Germany
Helios Klinikum Wuppertal
Wuppertal, Germany
Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Hungary
Szent Istvan Hospital
Budapest, Hungary
Italy
Ospedale C.G. Mazzoni
Ascoli Piceno, Italy
Bentivoglio Hospital
Bologna, Italy, 40010
Ospedale Santa Croce
Castelnuovo Garfagnana (Lucca), Italy
Presidio Ospedaliero di Cittadella
Cittadella (Padova), Italy
Ospedale Madonna delle Grazie
Matera, Italy
"Monzino" Cardiology Center
Milan, Italy, 20138
Ospedale Policlinico San Matteo
Pavia, Italy, 27100
Presidio Ospedaliero di Pistoia - UTIC
Pistoia, Italy
Hospital C.G. Mazzoni
Rome, Italy
Presidio Ospedaliero G. Fucito
Salerno, Italy
Presidio Ospedaliero
San Bonifacio, Italy
Ospedale Santa Corona
Savona, Italy
San Giovanni Battista "Le Molinette" Hospital
Turin, Italy
Belcolle Hospital
Viterbo, Italy
Korea, Republic of
Chonnam National University Hospital
Dong-gu, Kwangju, Korea, Republic of, 501-757
Kyngpook National University Hospital
Dae-gu, Korea, Republic of, 700-721
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
St. Paul's Hospital
Seoul, Korea, Republic of, 130-709
Severance Hospital
Seoul, Korea, Republic of, 120-752
Latvia
P. Stradina Clinical University Hospital
Riga, Latvia, LV-1002
Riga's 1st Hospital
Riga, Latvia, LV-1001
Lithuania
Kaunas University of Medicine Hospital
Kaunas, Lithuania, 3007
Vilnius University Hospital - Santariskiu Clinic
Vilnius, Lithuania, 2021
Malaysia
Department of Cardiology - Sarawak General Hospital
Kuching, Sarawak, Malaysia, 93586
Hospital Sultanah Aminah
Johor Bahru, Malaysia
Hospital Kota Bahru
Kelantan, Malaysia
Institut Jantung Negara
Kuala Lumpur, Malaysia, 50400
Department of Cardiology - Penang Hospital
Penang, Malaysia, 10990
Queen Elizabeth Hospital
Sabah, Malaysia
Mexico
Hospital General Regional (HGR) No. 45, Instituto Mexicano del Seguro Social (IMSS)
Guadalajara, Jalisco, Mexico
Hospital de Especialidades
Guadalajara, Jalisco, Mexico
Hospital General Regional 110, IMSS
Guadalajara, Jalisco, Mexico
Hospital "Dr. Angel Leano"
Zapopan, Jalisco, Mexico
Hospital Central Norte de Petroleos Mexicanos
Del Azcapotzalco, Mexico
Hospital Bernardette S.A. de C.V.
Guadalajara, Mexico
Hospital Juarez de Mexico
Mexico, Mexico
Hospital de Cardiologia
Mexico, D.F., Mexico
Hospital Regional "Dr. Valentin Gomez Farias" ISSSTE
Zapopan Jalisco, Mexico
Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Groene Hart Ziekenhuis, lokatie Bleuland
Gouda, Netherlands
Westfries Gasthuis
Hoorn, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Bernhoven Ziekenhuis, Lokatie Oss
Oss, Netherlands
Maaslandziekenhuis Sittard
Sittard, Netherlands
Isala Klinieken, lokatie Weezenlanden
Zwolle, Netherlands
New Zealand
North Shore Hospital
Auckland, New Zealand
Auckland City Hospital and Greenlane Clinical Centre
Auckland, New Zealand
Waikato Hospital
Hamilton, New Zealand
Hawkes Bay Hospital
Hastings, New Zealand
Nelson Hospital
Nelson, New Zealand
Tauranga Hospital
Tauranga, New Zealand
Wellington Hospital
Wellington South, New Zealand
Norway
The Hospital in Vestfold
Tonsberg, Norway, N-3103
Poland
Szpital Miejski im. dr. T. Chalubinskiego
Czestochowa, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Dzialdowo
Dzialdowo, Poland, 13-200
Szpital Specjalistyczny sw. Wojciecha - Adalberta
Gdansk, Poland, 80-462
Szpital Miejski im. J. Brudzinskiego
Gdynia, Poland, 81-348
Szpital Morski im. PCK
Gdynia, Poland, 81-519
SP Szpital Kliniczny Nr 7
Katowice, Poland, 40-635
Samodzielny Publiczny Szpital Kliniczny nr 7
Katowice, Poland
Wojewodzki Szpital Zespolony
Konin, Poland, 62-510
Uniwetsytecki Szpital Kliniczny nr 3
Lodz, Poland, 91-425
Miedziowego Centrum Zdrowia S.A.
Lubin, Poland
Spzoz Im J. Sniadeckiego
Nowy Sacz, Poland, 33-300
Wojewodzki Szpital Specjalistyczny
Olsztyn, Poland, 10-561
Wojewodzkie Centrum Medyczne
Opole, Poland, 45-418
Oddzial Kardiologii
Ostrowiec Swietokrzyski, Poland
Samodzielny Szpital Wojewodzki im. Mikolaja Kopernika
Piotrkow Trybunalski, Poland, 97-300
Szpital Wojewodzki w Poznaniu
Poznan, Poland, 60-479
SP ZOZ, Szpital Specjalistyczny
Pulawy, Poland
Radomski Szpital Specjalistyczny
Radom, Poland
Szpital Powiatowy
Radomsko, Poland, 97-500
Szpital Miejski nr 2
Ruda Slaska, Poland
Wojewodzki Szpital Zespolony
Skierniewice, Poland, 96-100
Szpitala Powiatowego w Sochaczewie
Sochaczew, Poland
Powiatowy Zaklad Opieki Zdrowotnej
Starachowice, Poland
Oddzial Kardiologii z Pododdzialem Intensywnej Opieki Kardiologicznej
Swidnik, Poland, 21-040
Specjalistyczny Szpital im. E. Szczeklika
Tarnow, Poland
Szpital Wojewodzki im. sw. Lukasza
Tarnow, Poland
Specjalistyczny Szpital Miejski im. M. Kopernika
Torun, Poland, 87-100
Specjalistyczny Szpital Im. A. Sokolowskiego
Walbrzych, Poland, 58-300
Szpital Grochowski im. dr med. Rafala Masztaka
Warszawa, Poland, 04-073
Wojewodzki Szpital Brodnowski
Warszawa, Poland
Szpital Specjalistyczny w Wejherowie
Wejherowo, Poland, 84-200
Szpital Specjalistyxzny w Zabrzu
Zabrze, Poland, 41-800
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
Zamosc, Poland
Portugal
Hospital Garoia de Orta, S.A.
Almada, Portugal
Hospital Infante D. Pedro
Aveiro, Portugal
Hospital de Santo Andre
Leiria, Portugal
Romania
Emergency Clinical County Hospital Arad
Arad, Romania
Emergency County Hospital Brasov
Brasov, Romania
Caritas Clinical Hospital Bucharest
Bucharest, Romania
Coltea Emergency Hospital, Bucharest
Bucharest, Romania
'Elias' Emergency Clinical County Hospital
Bucharest, Romania
Colentina Clinical Hospital, Bucharest
Bucharest, Romania
'N. Stancioiu' Heart Institute Cluj-Napoca
Cluj Napoca, Romania
Center of Cardiology Craiova
Craiova, Romania
"Sf. Spiridon" Emergency Clinical County Hospital, Iasi
Iasi, Romania
County Clinical Hospital Oradea
Oradea, Romania
Institute of Cardiovascular Diseases Timisoara
Timisoara, Romania
Russian Federation
Medical Foundation "Novaya Bolnitsa" as a base of Ural State Medical Academy
Ekaterinburg, Russian Federation, 620109
Institute of Clinical Cardiology of Cardiology Research Centre
Moscow, Russian Federation, 121552
City Clinical Hospital #29
Moscow, Russian Federation, 111020
Central Clinical Hospital of President Medical Center of Russian Federation
Moscow, Russian Federation, 121536
Veteran's Hospital #3
Moscow, Russian Federation, 129336
City Clinical Hospital #15
Moscow, Russian Federation
City Clinical Hospital #4
Moscow, Russian Federation, 113093
City Hospital #20
Moscow, Russian Federation, 129349
City Hospital #23
Moscow, Russian Federation, 109240
City Clinical Hospital #11
Moscow, Russian Federation, 103473
Federal State Institution Clinical Hospital of President Administration of Russian Federation
Moscow, Russian Federation
City Hospital # 6
Moscow, Russian Federation
City Clinical Hospital #36
Moscow, Russian Federation
City Clinical Hospital #64
Moscow, Russian Federation
City Clinical Hospital #33
Moscow, Russian Federation
City Clinical Hospital #70
Moscow, Russian Federation
Main Military Hospital named by Burdenko
Moscow, Russian Federation
City Hospital No. 51
Moscow, Russian Federation
Moscow Medical Sechenov Academy
Moscow, Russian Federation
Institute of Therapy of Siberian Department of RAMS
Novosibirsk, Russian Federation
Saratov Institute of Cardiology
Saratov, Russian Federation
Travel Hospital
St-Petersburg, Russian Federation
St-Petersburg Hospital #28
St-Petersburg, Russian Federation
Pokrovskaya City Hospital
St-Petersburg, Russian Federation
City Hospital #15
St-Petersburg, Russian Federation
St-George Hospital
St-Petersburg, Russian Federation
Alexandrovsky Hospital
St-Petersburg, Russian Federation
Central Medical Sanitary Hospital #122
St-Petersburg, Russian Federation
Cardiology Research Institute, St. Petersburg
St. Petersburg, Russian Federation, 194156
Scientific Research Institute of Cardiology of Tomsk Scientific Centre of Syberian Department of RAMS
Tomsk, Russian Federation
Tumen Cardiology Centre
Tumen, Russian Federation, 625026
Regional Clinical Hospital #3
Volgograd, Russian Federation
Voronezh City Clinical Hospital of Emergency Medicine
Voronezh, Russian Federation
Voronezh Regional Clinical Hospital #1
Voronezh, Russian Federation
Yaroslavl Regional Hospital
Yaroslavl, Russian Federation, 150062
Central Medical Sanitary Hospital #51
Zheleznogorsk, Russian Federation, 662971
Singapore
Department of Cardiology - Changi General Hospital
Changi, Singapore, 529889
Slovakia
Middle Slovak Heart Institute (SUSCH)
Banska Bystrica, Slovakia
Slovak Heart Institute (SUSCH)
Bratislava, Slovakia, 833 48
University Hospital
Martin, Slovakia, 036 59
University Hospital - Spitalska
Nitra, Slovakia, 950 01
Slovenia
General Hospital Celje
Celje, Slovenia
General Hospital Izola
Izola, Slovenia
University Medical Centre Ljubljana
Ljubljana, Slovenia
General Hospital Maribor
Maribor, Slovenia
General Hospital Novo Mesto
Novo Mesto, Slovenia
South Africa
Tijger Trials Centre - Karl Bremer Hospital
Bellville, South Africa, 7531
Department of Cardiology - Universitas Hospital
Bloemfontein, South Africa, 9301
Rosepark Hospital
Bloemfontein, South Africa, 9301
Cardiac Clinic - Groote Schuur Hospital
Cape Town, South Africa, 7925
George Hospital
George, South Africa
DJW Navorsing
Krugersdorp, South Africa, 1739
Lenmed Clinic
Lenasia, South Africa, 1827
GF Jooste Hospital
Mannenberg, South Africa, 7764
Hottentots Holland Hospital
Somerset West, South Africa, 7130
Vergelegen MediClinic
Somerset West, South Africa, 7130
Chris Hani Baragwanath Hospital
Soweto, South Africa, 1804
Spain
Hospital Clinic i Provincial
Barcelona, Spain
Hospital General de Jerez de la Frontera
Cadiz, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clinico Virgen de la Victoria
Malaga, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Son Dureta
Palma de Mallorca, Spain
Hospital Universitario Virgen de la Macarena
Sevilla, Spain
Hospital Nuestra Senora de Valme
Sevilla, Spain
Hospital General de Valencia
Valencia, Spain
Hospital Universitario Dr. Peset
Valencia, Spain
Sweden
Hoglandssjukhuset
Eksjo, Sweden, 575 81
Malarsjukhuset
Eskilstuna, Sweden, 631 88
Universitetssjukhuset
Linkoping, Sweden, 581 85
Universitetssjukhuset
Lund, Sweden
Medicinkliniken Lasarett
Motala, Sweden, 591 85
Orebro Universitetssjukhus
Orebro, Sweden
Lanssjukhuset
Sundsvall, Sweden
Akademiska sjukhuset
Uppsala, Sweden, 751 85
Vasterviks sjukhus
Vastervik, Sweden, 593 81
Switzerland
Herzklinik Bodensee am Weinberg
Kreuzlingen, Switzerland
Cardiocentro Ticino
Lugano, Switzerland
Taiwan
Chang Gung Memorial Hospital
Kaohsiung Hsien, Taiwan, 123
Mackay Memorial Hospital
Taipei, Taiwan, 92
National Taiwan University Hospital
Taipei, Taiwan
Ukraine
City Clinical Urgent Hospital No. 6
Crimea, Ukraine
City Joint Emergency Hospital
Dnepropetrovsk, Ukraine, 49005
Donetsk State Medical University
Donetsk, Ukraine
Institute of Recovery and Urgent Surgery
Donetsk, Ukraine
Regional Clinical Cardio Preventive Center
Ivano-Frankovsk, Ukraine, 76025
Central Clinical Hospital No. 5
Kharkov, Ukraine, 61018
City Clinical Hospital #8
Kharkov, Ukraine
City Hospital #27
Kharkov, Ukraine
Kiev Clinical Emergency Care Hospital
Kiev, Ukraine, 02660
City Clinical Hospital No. 1
Kiev, Ukraine
Clinical Railway Hospital No. 1
Kiev, Ukraine, 03049
Central City Clinical Hospital
Kiev, Ukraine, 01023
Ukranian Institute of Cardiology
Kiev, Ukraine
Lugansk Multifield City Clinical Hospital No. 1
Lugansk, Ukraine
Lviv Regional State Clinical Treatment-and-Diagnostic Cardiology Center
Lviv, Ukraine
City Hospital No. 1
Mykolayiv, Ukraine, 54003
City Clinical Hospital #3
Odessa, Ukraine
City Clinical Hospital No. 1
Vinnitsa, Ukraine
Zaporozhye Regional Cardiology Dispensary
Zaporozhye, Ukraine
Zaporozhye Regional Clinical Hospital
Zaporozhye, Ukraine
United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
OldChurch Hospital
Romford, United Kingdom
Scunthorpe District General Hospital
Scunthorpe, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Torbay Hospital
Torquay, United Kingdom
Sponsors and Collaborators
GlaxoSmithKline
Sanofi
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00064428     History of Changes
Obsolete Identifiers: NCT01352156
Other Study ID Numbers: 103413, EFC5112
Study First Received: July 8, 2003
Last Updated: August 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Acute Myocardial Infarction
ST-segment elevation myocardial infarction
fondaparinux
acute coronary syndrome

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Fondaparinux
PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 27, 2014