Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge (EPICOR)
16. april 2013 oppdatert av: 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.
Studieoversikt
Status
Fullført
Studietype
Observasjonsmessig
Registrering (Faktiske)
10568
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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, Belgia
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Aalst, Belgia
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Antwerpen, Belgia
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Brasschaat, Belgia
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Brugge, Belgia
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Brussel, Belgia
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Bruxelles, Belgia
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Charleroi, Belgia
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Chenee, Belgia
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Dendermonde, Belgia
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Edegem, Belgia
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Eeklo, Belgia
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Genk, Belgia
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La Louviere, Belgia
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Leuven, Belgia
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Lier, Belgia
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Merksem, Belgia
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Mol, Belgia
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Mons, Belgia
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Montigny-le-Tilleul, Belgia
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Namur, Belgia
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Oostende, Belgia
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Ottignies, Belgia
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Overpelt, Belgia
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Roeselare, Belgia
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Ronse, Belgia
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Seraing, Belgia
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Sint-Niklaas, Belgia
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Soignies, Belgia
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Tienen, Belgia
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Tournai, Belgia
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Turnhout, Belgia
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Veurne, Belgia
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Aracaju, Brasil
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Belo Horizonte, Brasil
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Blumenau, Brasil
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Brasilia, Brasil
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Campina Grande do Sul, Brasil
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Campo Grande, Brasil
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Curitiba, Brasil
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Marilia, Brasil
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Porto Alegre, Brasil
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Rio de Janeiro, Brasil
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Sao Jose do Rio Preto, Brasil
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Sao Paulo, Brasil
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Tatu, Brasil
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Uberlandia, Brasil
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Votuporanga, Brasil
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Aalborg, Danmark
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Aarhus, Danmark
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Arhus N, Danmark
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Esbjerg, Danmark
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Fredericia, Danmark
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Frederiksberg, Danmark
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Haderslev, Danmark
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Hellerup, Danmark
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Herning, Danmark
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Hjorring, Danmark
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Hvidovre, Danmark
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Kobenhavn NV, Danmark
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Kobenhavn o, Danmark
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Odense C, Danmark
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Silkeborg, Danmark
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Varde, Danmark
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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, Frankrike
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Argenteuil, Frankrike
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Avignon, Frankrike
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Belfort, Frankrike
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Boulogne Billancourt, Frankrike
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Bourges, Frankrike
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Brest, Frankrike
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Brive La Gaillarde, Frankrike
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Caen, Frankrike
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Chambery, Frankrike
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Chambray Les Tours, Frankrike
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Colmar, Frankrike
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Dijon, Frankrike
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Dunkerque, Frankrike
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Haguenau, Frankrike
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Hopital Civil (strasbourg Cedex), Frankrike
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La Rochelle, Frankrike
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La Source, Frankrike
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Lagny Sur Marne, Frankrike
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Le Chesnay, Frankrike
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Le Coudray, Frankrike
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Le Plessis Robinson, Frankrike
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Marignane, Frankrike
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Marseille, Frankrike
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Metz, Frankrike
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Montfermeil, Frankrike
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Montreuil, Frankrike
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Mulhouse, Frankrike
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Nice, Frankrike
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Paris, Frankrike
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Perpignan, Frankrike
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Quimper, Frankrike
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Reims, Frankrike
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St Brieuc, Frankrike
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St Michel, Frankrike
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Strasbourg Cedex, Frankrike
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Suresnes, Frankrike
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Valence, Frankrike
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Vandoeuvre Les Nancy, Frankrike
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Athens, Hellas
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Attika, Hellas
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Chalkida, Hellas
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Chania, Hellas
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Chios, Hellas
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Edessa, Hellas
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Elefsina, Hellas
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Heraklion, Hellas
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Ioannina, Hellas
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Larisa, Hellas
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Patra, Hellas
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Ptolemaida, Hellas
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Ancona, Italia
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Catania, Italia
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Catanzaro, Italia
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Ferrara, Italia
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Firenze, Italia
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Genova, Italia
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Massa, Italia
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Milano, Italia
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Napoli, Italia
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Napoli Caserta, Italia
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Nuoro, Italia
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Ospedale di Macerata, Italia
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Pescara, Italia
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Prato, Italia
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Rho, Italia
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Rimini, Italia
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Roma, Italia
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Rovigo, Italia
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Sassari, Italia
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Siracusa, Italia
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Treviso, Italia
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Udine, Italia
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Varese, Italia
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Versilia, Italia
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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, Nederland
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Amsterdam, Nederland
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Bergen op Zoom, Nederland
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Beverwijk, Nederland
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Delft, Nederland
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Den Bosh, Nederland
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Den Haag, Nederland
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Doetinchem, Nederland
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Goes, Nederland
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Haarlem, Nederland
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Heerlen, Nederland
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Hoofddorp, Nederland
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Hoogeveen, Nederland
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Meppel, Nederland
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Purmerend, Nederland
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Stadskanaal, Nederland
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Winterswijk, Nederland
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Zwolle, Nederland
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Bergen, Norge
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Bodo, Norge
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Elverum, Norge
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Flekkefjord, Norge
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Forde, Norge
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Gjovik, Norge
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Hamar, Norge
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Hammerfest, Norge
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Harstad, Norge
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Haugesund, Norge
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Honefoss, Norge
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Kongsvinger, Norge
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Kristiansund N, Norge
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Levanger, Norge
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Lillehammer, Norge
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Lorenskog, Norge
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Molde, Norge
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Oslo, Norge
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Rjukan, Norge
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Rud, Norge
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Skien, Norge
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Tonsberg, Norge
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Tromso, Norge
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Trondheim, Norge
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Tynset, Norge
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Bydgoszcz, Polen
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Elblag, Polen
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Jelenia Gora, Polen
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Kalisz, Polen
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Koszalin, Polen
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Krakow, Polen
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Olawa, Polen
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Olsztyn, Polen
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Opole, Polen
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Ostrow Maz., Polen
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Poznan, Polen
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Pruszkow, Polen
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Radom, Polen
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Sandomierz, Polen
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Slupsk, Polen
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Starogard Gdanski, Polen
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Tarnow, Polen
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Torun, Polen
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Walbrzych, Polen
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Warszawa, Polen
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Wloclawek, Polen
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Wroclaw, Polen
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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, Spania
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Alcoy, Spania
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Alicante, Spania
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Aranjuez, Spania
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Avila, Spania
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Barcelona, Spania
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Baza, Spania
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Ciudad Real, Spania
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Coslada, Spania
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Elche, Spania
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Elda, Spania
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Ferrol, Spania
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Fuenlabrada, Spania
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Gandia, Spania
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Gerona, Spania
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Huelva, Spania
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Huercal-Overa, Spania
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Huesca, Spania
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Igualada, Spania
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Leon, Spania
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Lugo, Spania
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Madrid, Spania
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Palencia, Spania
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Pozoblanco, Spania
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Puertollano, Spania
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Salamanca, Spania
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San Juan, Spania
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San Sebastian de los Reyes, Spania
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Santiago de Compostela, Spania
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Segovia, Spania
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Sevilla, Spania
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Tarragona, Spania
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Terrassa, Spania
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Toledo, Spania
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Torrevieja, Spania
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Tortosa, Spania
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Valencia, Spania
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Velez-Malaga, Spania
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Vic, Spania
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Villa Joyosa, Spania
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Zaragoza, Spania
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Airdrie, Storbritannia
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Antrim, Storbritannia
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Basingstoke, Storbritannia
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Belfast, Storbritannia
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Birmingham, Storbritannia
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Blackburn, Storbritannia
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Blackpool, Storbritannia
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Craigavon, Storbritannia
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Croydon, Storbritannia
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East Kilbride, Storbritannia
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Essex, Storbritannia
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Glasgow, Storbritannia
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Harrow, Storbritannia
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Hastings, Storbritannia
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Hertfordshire, Storbritannia
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High Wycombe, Storbritannia
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Kirkcaldy, Storbritannia
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Livingston, Storbritannia
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London, Storbritannia
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Manchester, Storbritannia
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Middlesbrough, Storbritannia
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Morriston Hospital (Swansea), Storbritannia
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Newcastle Upon Tyne, Storbritannia
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Peterborough, Storbritannia
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Rotherham, Storbritannia
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Sheffield, Storbritannia
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Stevenage, Storbritannia
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Sutton Coldfield, Storbritannia
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Worcester, Storbritannia
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Adana, Tyrkia
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Ankara, Tyrkia
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Antalya, Tyrkia
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Canakkale, Tyrkia
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Diyarbak?r, Tyrkia
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Elaz?g, Tyrkia
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Erzurum, Tyrkia
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Eskisehir, Tyrkia
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Gaziantep, Tyrkia
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Istanbul, Tyrkia
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Izmir, Tyrkia
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Kayseri, Tyrkia
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Konya, Tyrkia
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Malatya, Tyrkia
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Manisa, Tyrkia
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Mersin, Tyrkia
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Samsun, Tyrkia
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Sivas, Tyrkia
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Trabzon, Tyrkia
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Berlin, Tyskland
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Bielefeld, Tyskland
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Bochum, Tyskland
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Bonn, Tyskland
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Borken, Tyskland
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Cloppenburg, Tyskland
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Coburg, Tyskland
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Detmold, Tyskland
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Dortmund, Tyskland
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Essen, Tyskland
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Esslingen, Tyskland
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Greifswald, Tyskland
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Hannover, Tyskland
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Heidelberg, Tyskland
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Herrsching, Tyskland
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Landshut, Tyskland
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Leverkusen, Tyskland
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Lubeck, Tyskland
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Ludwigshafen, Tyskland
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Mainz, Tyskland
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Merseburg, Tyskland
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Monchengladbach, Tyskland
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Muhlheim, Tyskland
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Olsberg, Tyskland
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Regensburg, Tyskland
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Rostock, Tyskland
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Stuttgart, Tyskland
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Suhl, Tyskland
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Warendorf, Tyskland
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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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
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1
Patients, older than 18, hospitalized within 24 hours of onset of symptoms and diagnosed with UA, STEMI or NSTEMI
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Clinical outcomes (ischemic and bleeding) incidence and time to these clinical outcomes
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Antithrombotic treatments
Tidsramme: 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)
|
|
Use of health care resources
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Mónica Tafalla, Medical Department.AstraZeneca Spain
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2010
Primær fullføring (Faktiske)
1. mars 2013
Studiet fullført (Faktiske)
1. mars 2013
Datoer for studieregistrering
Først innsendt
27. juli 2010
Først innsendt som oppfylte QC-kriteriene
27. juli 2010
Først lagt ut (Anslag)
28. juli 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. april 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. april 2013
Sist bekreftet
1. april 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Iskemi
- Patologiske prosesser
- Nekrose
- Myokardiskemi
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Arteriosklerose
- Arterielle okklusive sykdommer
- Smerte
- Nevrologiske manifestasjoner
- Sykdom
- Koronar sykdom
- Brystsmerter
- Angina pectoris
- Hjerteinfarkt
- Infarkt
- Koronararteriesykdom
- Syndrom
- Akutt koronarsyndrom
- Angina, ustabil
Andre studie-ID-numre
- NIS-CEU-DUM-2009/1
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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