Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge (EPICOR)
April 16, 2013 updated by: AstraZeneca
Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients
The aim of this international study is to describe the short- and long-term (i.e. up to 2 years following the index event) antithrombotic management patterns (AMPs) in patients hospitalized for acute coronary syndromes (ST segment elevation myocardial infarction (STEMI), Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS)), and to document the impact of AMPs in clinical outcomes, economic variables and quality of life in a 'real-life' setting and to compare these between sites, countries and regions.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
10568
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Avellaneda, Argentina
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Bahia Blanca, Argentina
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Ciudad Autonoma de Buenos Aires, Argentina
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Ciudadela, Argentina
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Cordoba, Argentina
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Corrientes, Argentina
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General Roca, Argentina
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Mar del Plata, Argentina
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Mendoza, Argentina
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Monteros, Argentina
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Quilmes, Argentina
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Rosario, Argentina
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Salta, Argentina
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San Isidro, Argentina
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San Miguel de Tucuman, Argentina
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San Salvador de Jujuy, Argentina
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(Jette) Bruxelles, Belgium
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Aalst, Belgium
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Antwerpen, Belgium
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Brasschaat, Belgium
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Brugge, Belgium
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Brussel, Belgium
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Bruxelles, Belgium
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Charleroi, Belgium
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Chenee, Belgium
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Dendermonde, Belgium
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Edegem, Belgium
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Eeklo, Belgium
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Genk, Belgium
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La Louviere, Belgium
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Leuven, Belgium
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Lier, Belgium
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Merksem, Belgium
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Mol, Belgium
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Mons, Belgium
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Montigny-le-Tilleul, Belgium
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Namur, Belgium
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Oostende, Belgium
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Ottignies, Belgium
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Overpelt, Belgium
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Roeselare, Belgium
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Ronse, Belgium
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Seraing, Belgium
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Sint-Niklaas, Belgium
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Soignies, Belgium
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Tienen, Belgium
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Tournai, Belgium
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Turnhout, Belgium
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Veurne, Belgium
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Aracaju, Brazil
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Belo Horizonte, Brazil
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Blumenau, Brazil
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Brasilia, Brazil
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Campina Grande do Sul, Brazil
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Campo Grande, Brazil
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Curitiba, Brazil
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Marilia, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Sao Jose do Rio Preto, Brazil
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Sao Paulo, Brazil
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Tatu, Brazil
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Uberlandia, Brazil
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Votuporanga, Brazil
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Aalborg, Denmark
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Aarhus, Denmark
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Arhus N, Denmark
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Esbjerg, Denmark
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Fredericia, Denmark
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Frederiksberg, Denmark
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Haderslev, Denmark
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Hellerup, Denmark
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Herning, Denmark
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Hjorring, Denmark
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Hvidovre, Denmark
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Kobenhavn NV, Denmark
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Kobenhavn o, Denmark
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Odense C, Denmark
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Silkeborg, Denmark
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Varde, Denmark
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Espoo, Finland
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Helsinki, Finland
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Jyväskylä, Finland
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Kuopio, Finland
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Lahti, Finland
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Rovaniemi, Finland
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Seinäjoki, Finland
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Tampere, Finland
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Turku, Finland
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Antony, France
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Argenteuil, France
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Avignon, France
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Belfort, France
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Boulogne Billancourt, France
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Bourges, France
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Brest, France
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Brive La Gaillarde, France
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Caen, France
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Chambery, France
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Chambray Les Tours, France
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Colmar, France
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Dijon, France
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Dunkerque, France
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Haguenau, France
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Hopital Civil (strasbourg Cedex), France
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La Rochelle, France
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La Source, France
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Lagny Sur Marne, France
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Le Chesnay, France
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Le Coudray, France
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Le Plessis Robinson, France
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Marignane, France
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Marseille, France
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Metz, France
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Montfermeil, France
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Montreuil, France
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Mulhouse, France
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Nice, France
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Paris, France
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Perpignan, France
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Quimper, France
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Reims, France
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St Brieuc, France
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St Michel, France
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Strasbourg Cedex, France
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Suresnes, France
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Valence, France
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Vandoeuvre Les Nancy, France
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Berlin, Germany
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Bielefeld, Germany
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Bochum, Germany
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Bonn, Germany
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Borken, Germany
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Cloppenburg, Germany
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Coburg, Germany
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Detmold, Germany
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Dortmund, Germany
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Essen, Germany
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Esslingen, Germany
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Greifswald, Germany
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Hannover, Germany
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Heidelberg, Germany
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Herrsching, Germany
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Landshut, Germany
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Leverkusen, Germany
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Lubeck, Germany
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Ludwigshafen, Germany
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Mainz, Germany
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Merseburg, Germany
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Monchengladbach, Germany
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Muhlheim, Germany
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Olsberg, Germany
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Regensburg, Germany
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Rostock, Germany
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Stuttgart, Germany
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Suhl, Germany
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Warendorf, Germany
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Athens, Greece
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Attika, Greece
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Chalkida, Greece
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Chania, Greece
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Chios, Greece
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Edessa, Greece
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Elefsina, Greece
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Heraklion, Greece
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Ioannina, Greece
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Larisa, Greece
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Patra, Greece
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Ptolemaida, Greece
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Ancona, Italy
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Catania, Italy
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Catanzaro, Italy
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Ferrara, Italy
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Firenze, Italy
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Genova, Italy
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Massa, Italy
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Milano, Italy
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Napoli, Italy
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Napoli Caserta, Italy
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Nuoro, Italy
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Ospedale di Macerata, Italy
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Pescara, Italy
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Prato, Italy
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Rho, Italy
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Rimini, Italy
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Roma, Italy
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Rovigo, Italy
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Sassari, Italy
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Siracusa, Italy
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Treviso, Italy
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Udine, Italy
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Varese, Italy
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Versilia, Italy
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Luxembourg, Luxembourg
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Cardenas, Tabasco, Mexico
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Chihuahua, Mexico
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Chihuahua, Chihuahua, Mexico
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Durango, Mexico
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Durango, Durango, Mexico
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Guadalajara, Mexico
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Guadalajara, Jalisco, Mexico
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Guanajuato, Mexico
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Leon Guanajuato, Mexico
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Merida, Yucatan, Mexico
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Mexicali, Baja California, Mexico
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Mexico City, Mexico
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Monterrey, Nuevo Leon, Mexico
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Oaxaca, Oaxaca, Mexico
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Puebla, Puebla, Mexico
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Queretaro, Mexico
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Saltillo Coahuila, Mexico
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San Luis Potosi, Mexico
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Sinaloa, Culiacan, Mexico
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Tabasco, Mexico
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Tijuana B.C., Mexico
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Toluca, Estado de Mexico, Mexico
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Torreon, Mexico
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Torreon Coahuila, Mexico
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Xalapa, Veracruz, Mexico
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Amstelveen, Netherlands
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Amsterdam, Netherlands
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Bergen op Zoom, Netherlands
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Beverwijk, Netherlands
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Delft, Netherlands
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Den Bosh, Netherlands
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Den Haag, Netherlands
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Doetinchem, Netherlands
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Goes, Netherlands
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Haarlem, Netherlands
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Heerlen, Netherlands
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Hoofddorp, Netherlands
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Hoogeveen, Netherlands
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Meppel, Netherlands
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Purmerend, Netherlands
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Stadskanaal, Netherlands
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Winterswijk, Netherlands
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Zwolle, Netherlands
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Bergen, Norway
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Bodo, Norway
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Elverum, Norway
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Flekkefjord, Norway
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Forde, Norway
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Gjovik, Norway
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Hamar, Norway
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Hammerfest, Norway
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Harstad, Norway
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Haugesund, Norway
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Honefoss, Norway
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Kongsvinger, Norway
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Kristiansund N, Norway
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Levanger, Norway
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Lillehammer, Norway
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Lorenskog, Norway
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Molde, Norway
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Oslo, Norway
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Rjukan, Norway
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Rud, Norway
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Skien, Norway
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Tonsberg, Norway
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Tromso, Norway
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Trondheim, Norway
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Tynset, Norway
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Bydgoszcz, Poland
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Elblag, Poland
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Jelenia Gora, Poland
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Kalisz, Poland
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Koszalin, Poland
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Krakow, Poland
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Olawa, Poland
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Olsztyn, Poland
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Opole, Poland
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Ostrow Maz., Poland
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Poznan, Poland
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Pruszkow, Poland
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Radom, Poland
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Sandomierz, Poland
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Slupsk, Poland
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Starogard Gdanski, Poland
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Tarnow, Poland
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Torun, Poland
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Walbrzych, Poland
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Warszawa, Poland
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Wloclawek, Poland
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Wroclaw, Poland
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Alba Iulia, Romania
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Arad, Romania
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Bacau, Romania
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Baia Mare, Romania
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Bistrita, Romania
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Braila, Romania
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Brasov, Romania
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Bucuresti, Romania
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Buzau, Romania
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Cluj Napoca, Romania
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Constanta, Romania
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Craiova, Romania
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Drobeta-turnu Severin, Romania
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Focsani, Romania
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Galati, Romania
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Hunedoara, Romania
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Iasi, Romania
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Oradea, Romania
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Piatra Neamt, Romania
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Pitesti, Romania
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Ploiesti, Romania
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Ramnicu Valcea, Romania
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Sibiu, Romania
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Slatina, Romania
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Suceava, Romania
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Targoviste, Romania
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Targu Mures, Romania
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Timisoara, Romania
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Zalau, Romania
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Ljubljana, Slovenia
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Maribor, Slovenia
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Alcala de Henares, Spain
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Alcoy, Spain
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Alicante, Spain
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Aranjuez, Spain
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Avila, Spain
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Barcelona, Spain
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Baza, Spain
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Ciudad Real, Spain
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Coslada, Spain
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Elche, Spain
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Elda, Spain
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Ferrol, Spain
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Fuenlabrada, Spain
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Gandia, Spain
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Gerona, Spain
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Huelva, Spain
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Huercal-Overa, Spain
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Huesca, Spain
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Igualada, Spain
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Leon, Spain
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Lugo, Spain
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Madrid, Spain
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Palencia, Spain
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Pozoblanco, Spain
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Puertollano, Spain
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Salamanca, Spain
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San Juan, Spain
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San Sebastian de los Reyes, Spain
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Santiago de Compostela, Spain
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Segovia, Spain
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Sevilla, Spain
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Tarragona, Spain
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Terrassa, Spain
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Toledo, Spain
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Torrevieja, Spain
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Tortosa, Spain
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Valencia, Spain
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Velez-Malaga, Spain
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Vic, Spain
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Villa Joyosa, Spain
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Zaragoza, Spain
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Adana, Turkey
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Ankara, Turkey
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Antalya, Turkey
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Canakkale, Turkey
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Diyarbak?r, Turkey
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Elaz?g, Turkey
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Erzurum, Turkey
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Eskisehir, Turkey
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Gaziantep, Turkey
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Istanbul, Turkey
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Izmir, Turkey
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Kayseri, Turkey
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Konya, Turkey
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Malatya, Turkey
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Manisa, Turkey
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Mersin, Turkey
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Samsun, Turkey
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Sivas, Turkey
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Trabzon, Turkey
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Airdrie, United Kingdom
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Antrim, United Kingdom
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Basingstoke, United Kingdom
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Belfast, United Kingdom
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Birmingham, United Kingdom
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Blackburn, United Kingdom
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Blackpool, United Kingdom
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Craigavon, United Kingdom
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Croydon, United Kingdom
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East Kilbride, United Kingdom
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Essex, United Kingdom
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Glasgow, United Kingdom
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Harrow, United Kingdom
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Hastings, United Kingdom
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Hertfordshire, United Kingdom
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High Wycombe, United Kingdom
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Kirkcaldy, United Kingdom
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Livingston, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Middlesbrough, United Kingdom
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Morriston Hospital (Swansea), United Kingdom
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Newcastle Upon Tyne, United Kingdom
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Peterborough, United Kingdom
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Rotherham, United Kingdom
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Sheffield, United Kingdom
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Stevenage, United Kingdom
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Sutton Coldfield, United Kingdom
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Worcester, United Kingdom
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Barquisimeto, Venezuela
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Caracas, Venezuela
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Coro, Venezuela
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Maracaibo, Venezuela
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Maracay, Venezuela
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Oriente, Venezuela
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Valencia, Venezuela
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients hospitalized within 24 hours of onset of symptoms and diagnosed with unstable angina (UA), STEMI or non-STEMI(NSTEMI). Patients will be invited to participate by the hospital (Academic or Community) which is going to discharge the patient.
Participating investigators will belong to hospitals (Academic, Community, with/without cathlab, etc), in the proportion representing the reality of where this kind of patients are managed in each country.
Description
Inclusion Criteria:
- Diagnosis of myocardial infarction or unstable angina
- Hospitalized for the first time within 24 hours of onset of symptoms
Exclusion Criteria:
- Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances)
- Current participation in a clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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1
Patients, older than 18, hospitalized within 24 hours of onset of symptoms and diagnosed with UA, STEMI or NSTEMI
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Clinical outcomes (ischemic and bleeding) incidence and time to these clinical outcomes
Time Frame: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
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Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Antithrombotic treatments
Time Frame: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
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Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
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Use of health care resources
Time Frame: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
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Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
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Quality of life
Time Frame: At index event (baseline) and then at 6 weeks and each 3 months after index event
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At index event (baseline) and then at 6 weeks and each 3 months after index event
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mónica Tafalla, Medical Department.AstraZeneca Spain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Huo Y, Van de Werf F, Han Y, Rossello X, Pocock SJ, Chin CT, Lee SW, Li Y, Jiang J, Vega AM, Medina J, Bueno H. Long-Term Antithrombotic Therapy and Clinical Outcomes in Patients with Acute Coronary Syndrome and Renal Impairment: Insights from EPICOR and EPICOR Asia. Am J Cardiovasc Drugs. 2021 Jul;21(4):471-482. doi: 10.1007/s40256-020-00447-5. Epub 2021 Feb 4.
- Martín-Asenjo R, Gregson J, Rossello X, Van de Werf F, Medina J, Danchin N, Pocock S, Bueno H. Number of Antithrombotic Drugs Used Early and In-hospital Outcomes in Acute Coronary Syndromes. J Cardiovasc Transl Res. 2021 Aug;14(4):790-798. doi: 10.1007/s12265-020-10094-5. Epub 2021 Jan 8.
- Stepinska J, Wojtkowska I, Annemans L, Danchin N, Pocock SJ, de Werf FV, Medina J, Bueno H. Long-Term Outcome of Acute Coronary Syndromes in Patients on Chronic Oral Anticoagulants: Data from the EPICOR Study. Curr Vasc Pharmacol. 2020;18(1):92-99. doi: 10.2174/1570161117666181227122355.
- Bardaji A, Leal M, Arrarte V, Garcia-Moll X, Perez de Isla L, Bueno H. Extended dual antiplatelet therapy after acute coronary syndrome in Spain: Results from the EPICOR study. Cardiovasc Ther. 2017 Apr;35(2). doi: 10.1111/1755-5922.12237.
- Bueno H, Pocock S, Danchin N, Annemans L, Gregson J, Medina J, Van de Werf F. International patterns of dual antiplatelet therapy duration after acute coronary syndromes. Heart. 2017 Jan 15;103(2):132-138. doi: 10.1136/heartjnl-2016-309509. Epub 2016 Aug 8.
- Annemans L, Danchin N, Van de Werf F, Pocock S, Licour M, Medina J, Bueno H. Prehospital and in-hospital use of healthcare resources in patients surviving acute coronary syndromes: an analysis of the EPICOR registry. Open Heart. 2016 Feb 24;3(1):e000347. doi: 10.1136/openhrt-2015-000347. eCollection 2016.
- Beauloye C, Vrolix M, Claeys MJ, van de Borne P, Vandendriessche E, Van De Werf F. Pre-hospital management of acute coronary syndrome patients in Belgium and Luxembourg and other Western European countries. Acta Cardiol. 2016 Feb;71(1):15-24. doi: 10.2143/AC.71.1.3132093.
- Zeymer U, Heuer H, Schwimmbeck P, Genth-Zotz S, Wolff K, Nienaber CA; EPICOR Investigators. Guideline-adherent therapy in patients with acute coronary syndromes. The EPICOR registry in Germany. Herz. 2015 Mar;40 Suppl 1:27-35. doi: 10.1007/s00059-014-4161-7. Epub 2014 Nov 7.
- Pocock S, Bueno H, Licour M, Medina J, Zhang L, Annemans L, Danchin N, Huo Y, Van de Werf F. Predictors of one-year mortality at hospital discharge after acute coronary syndromes: A new risk score from the EPICOR (long-tErm follow uP of antithrombotic management patterns In acute CORonary syndrome patients) study. Eur Heart J Acute Cardiovasc Care. 2015 Dec;4(6):509-17. doi: 10.1177/2048872614554198. Epub 2014 Oct 9.
- Bueno H, Danchin N, Tafalla M, Bernaud C, Annemans L, Van de Werf F. EPICOR (long-tErm follow-up of antithrombotic management Patterns In acute CORonary syndrome patients) study: rationale, design, and baseline characteristics. Am Heart J. 2013 Jan;165(1):8-14. doi: 10.1016/j.ahj.2012.10.018. Epub 2012 Nov 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
July 27, 2010
First Submitted That Met QC Criteria
July 27, 2010
First Posted (Estimate)
July 28, 2010
Study Record Updates
Last Update Posted (Estimate)
April 17, 2013
Last Update Submitted That Met QC Criteria
April 16, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pain
- Neurologic Manifestations
- Disease
- Coronary Disease
- Chest Pain
- Angina Pectoris
- Myocardial Infarction
- Infarction
- Coronary Artery Disease
- Syndrome
- Acute Coronary Syndrome
- Angina, Unstable
Other Study ID Numbers
- NIS-CEU-DUM-2009/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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