MICHELANGELO OASIS-6 : Fondaparinux in ST Elevation Myocardial Infarction
This study has been completed.
Sponsor:
GlaxoSmithKline
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064428
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| 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 June 18, 2013