Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge (EPICOR)
16 de abril de 2013 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Tipo de estudio
De observación
Inscripción (Actual)
10568
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania
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Bielefeld, Alemania
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Bochum, Alemania
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Bonn, Alemania
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Borken, Alemania
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Cloppenburg, Alemania
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Coburg, Alemania
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Detmold, Alemania
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Dortmund, Alemania
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Essen, Alemania
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Esslingen, Alemania
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Greifswald, Alemania
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Hannover, Alemania
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Heidelberg, Alemania
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Herrsching, Alemania
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Landshut, Alemania
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Leverkusen, Alemania
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Lubeck, Alemania
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Ludwigshafen, Alemania
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Mainz, Alemania
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Merseburg, Alemania
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Monchengladbach, Alemania
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Muhlheim, Alemania
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Olsberg, Alemania
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Regensburg, Alemania
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Rostock, Alemania
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Stuttgart, Alemania
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Suhl, Alemania
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Warendorf, Alemania
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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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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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(Jette) Bruxelles, Bélgica
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Aalst, Bélgica
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Antwerpen, Bélgica
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Brasschaat, Bélgica
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Brugge, Bélgica
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Brussel, Bélgica
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Bruxelles, Bélgica
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Charleroi, Bélgica
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Chenee, Bélgica
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Dendermonde, Bélgica
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Edegem, Bélgica
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Eeklo, Bélgica
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Genk, Bélgica
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La Louviere, Bélgica
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Leuven, Bélgica
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Lier, Bélgica
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Merksem, Bélgica
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Mol, Bélgica
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Mons, Bélgica
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Montigny-le-Tilleul, Bélgica
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Namur, Bélgica
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Oostende, Bélgica
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Ottignies, Bélgica
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Overpelt, Bélgica
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Roeselare, Bélgica
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Ronse, Bélgica
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Seraing, Bélgica
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Sint-Niklaas, Bélgica
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Soignies, Bélgica
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Tienen, Bélgica
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Tournai, Bélgica
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Turnhout, Bélgica
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Veurne, Bélgica
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Aalborg, Dinamarca
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Aarhus, Dinamarca
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Arhus N, Dinamarca
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Esbjerg, Dinamarca
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Fredericia, Dinamarca
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Frederiksberg, Dinamarca
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Haderslev, Dinamarca
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Hellerup, Dinamarca
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Herning, Dinamarca
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Hjorring, Dinamarca
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Hvidovre, Dinamarca
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Kobenhavn NV, Dinamarca
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Kobenhavn o, Dinamarca
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Odense C, Dinamarca
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Silkeborg, Dinamarca
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Varde, Dinamarca
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Ljubljana, Eslovenia
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Maribor, Eslovenia
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Alcala de Henares, España
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Alcoy, España
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Alicante, España
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Aranjuez, España
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Avila, España
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Barcelona, España
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Baza, España
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Ciudad Real, España
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Coslada, España
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Elche, España
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Elda, España
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Ferrol, España
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Fuenlabrada, España
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Gandia, España
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Gerona, España
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Huelva, España
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Huercal-Overa, España
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Huesca, España
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Igualada, España
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Leon, España
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Lugo, España
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Madrid, España
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Palencia, España
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Pozoblanco, España
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Puertollano, España
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Salamanca, España
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San Juan, España
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San Sebastian de los Reyes, España
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Santiago de Compostela, España
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Segovia, España
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Sevilla, España
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Tarragona, España
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Terrassa, España
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Toledo, España
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Torrevieja, España
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Tortosa, España
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Valencia, España
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Velez-Malaga, España
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Vic, España
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Villa Joyosa, España
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Zaragoza, España
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Espoo, Finlandia
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Helsinki, Finlandia
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Jyväskylä, Finlandia
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Kuopio, Finlandia
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Lahti, Finlandia
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Rovaniemi, Finlandia
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Seinäjoki, Finlandia
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Tampere, Finlandia
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Turku, Finlandia
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Antony, Francia
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Argenteuil, Francia
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Avignon, Francia
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Belfort, Francia
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Boulogne Billancourt, Francia
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Bourges, Francia
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Brest, Francia
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Brive La Gaillarde, Francia
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Caen, Francia
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Chambery, Francia
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Chambray Les Tours, Francia
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Colmar, Francia
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Dijon, Francia
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Dunkerque, Francia
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Haguenau, Francia
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Hopital Civil (strasbourg Cedex), Francia
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La Rochelle, Francia
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La Source, Francia
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Lagny Sur Marne, Francia
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Le Chesnay, Francia
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Le Coudray, Francia
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Le Plessis Robinson, Francia
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Marignane, Francia
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Marseille, Francia
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Metz, Francia
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Montfermeil, Francia
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Montreuil, Francia
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Mulhouse, Francia
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Nice, Francia
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Paris, Francia
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Perpignan, Francia
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Quimper, Francia
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Reims, Francia
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St Brieuc, Francia
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St Michel, Francia
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Strasbourg Cedex, Francia
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Suresnes, Francia
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Valence, Francia
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Vandoeuvre Les Nancy, Francia
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Athens, Grecia
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Attika, Grecia
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Chalkida, Grecia
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Chania, Grecia
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Chios, Grecia
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Edessa, Grecia
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Elefsina, Grecia
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Heraklion, Grecia
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Ioannina, Grecia
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Larisa, Grecia
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Patra, Grecia
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Ptolemaida, Grecia
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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, Luxemburgo
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Cardenas, Tabasco, México
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Chihuahua, México
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Chihuahua, Chihuahua, México
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Durango, México
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Durango, Durango, México
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Guadalajara, México
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Guadalajara, Jalisco, México
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Guanajuato, México
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Leon Guanajuato, México
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Merida, Yucatan, México
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Mexicali, Baja California, México
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Mexico City, México
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Monterrey, Nuevo Leon, México
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Oaxaca, Oaxaca, México
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Puebla, Puebla, México
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Queretaro, México
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Saltillo Coahuila, México
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San Luis Potosi, México
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Sinaloa, Culiacan, México
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Tabasco, México
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Tijuana B.C., México
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Toluca, Estado de Mexico, México
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Torreon, México
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Torreon Coahuila, México
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Xalapa, Veracruz, México
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Bergen, Noruega
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Bodo, Noruega
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Elverum, Noruega
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Flekkefjord, Noruega
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Forde, Noruega
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Gjovik, Noruega
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Hamar, Noruega
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Hammerfest, Noruega
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Harstad, Noruega
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Haugesund, Noruega
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Honefoss, Noruega
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Kongsvinger, Noruega
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Kristiansund N, Noruega
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Levanger, Noruega
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Lillehammer, Noruega
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Lorenskog, Noruega
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Molde, Noruega
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Oslo, Noruega
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Rjukan, Noruega
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Rud, Noruega
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Skien, Noruega
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Tonsberg, Noruega
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Tromso, Noruega
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Trondheim, Noruega
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Tynset, Noruega
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Adana, Pavo
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Ankara, Pavo
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Antalya, Pavo
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Canakkale, Pavo
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Diyarbak?r, Pavo
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Elaz?g, Pavo
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Erzurum, Pavo
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Eskisehir, Pavo
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Gaziantep, Pavo
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Istanbul, Pavo
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Izmir, Pavo
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Kayseri, Pavo
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Konya, Pavo
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Malatya, Pavo
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Manisa, Pavo
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Mersin, Pavo
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Samsun, Pavo
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Sivas, Pavo
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Trabzon, Pavo
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Amstelveen, Países Bajos
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Amsterdam, Países Bajos
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Bergen op Zoom, Países Bajos
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Beverwijk, Países Bajos
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Delft, Países Bajos
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Den Bosh, Países Bajos
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Den Haag, Países Bajos
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Doetinchem, Países Bajos
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Goes, Países Bajos
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Haarlem, Países Bajos
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Heerlen, Países Bajos
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Hoofddorp, Países Bajos
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Hoogeveen, Países Bajos
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Meppel, Países Bajos
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Purmerend, Países Bajos
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Stadskanaal, Países Bajos
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Winterswijk, Países Bajos
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Zwolle, Países Bajos
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Bydgoszcz, Polonia
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Elblag, Polonia
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Jelenia Gora, Polonia
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Kalisz, Polonia
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Koszalin, Polonia
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Krakow, Polonia
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Olawa, Polonia
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Olsztyn, Polonia
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Opole, Polonia
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Ostrow Maz., Polonia
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Poznan, Polonia
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Pruszkow, Polonia
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Radom, Polonia
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Sandomierz, Polonia
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Slupsk, Polonia
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Starogard Gdanski, Polonia
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Tarnow, Polonia
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Torun, Polonia
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Walbrzych, Polonia
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Warszawa, Polonia
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Wloclawek, Polonia
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Wroclaw, Polonia
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Airdrie, Reino Unido
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Antrim, Reino Unido
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Basingstoke, Reino Unido
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Belfast, Reino Unido
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Birmingham, Reino Unido
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Blackburn, Reino Unido
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Blackpool, Reino Unido
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Craigavon, Reino Unido
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Croydon, Reino Unido
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East Kilbride, Reino Unido
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Essex, Reino Unido
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Glasgow, Reino Unido
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Harrow, Reino Unido
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Hastings, Reino Unido
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Hertfordshire, Reino Unido
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High Wycombe, Reino Unido
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Kirkcaldy, Reino Unido
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Livingston, Reino Unido
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London, Reino Unido
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Manchester, Reino Unido
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Middlesbrough, Reino Unido
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Morriston Hospital (Swansea), Reino Unido
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Newcastle Upon Tyne, Reino Unido
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Peterborough, Reino Unido
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Rotherham, Reino Unido
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Sheffield, Reino Unido
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Stevenage, Reino Unido
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Sutton Coldfield, Reino Unido
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Worcester, Reino Unido
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Alba Iulia, Rumania
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Arad, Rumania
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Bacau, Rumania
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Baia Mare, Rumania
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Bistrita, Rumania
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Braila, Rumania
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Brasov, Rumania
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Bucuresti, Rumania
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Buzau, Rumania
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Cluj Napoca, Rumania
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Constanta, Rumania
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Craiova, Rumania
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Drobeta-turnu Severin, Rumania
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Focsani, Rumania
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Galati, Rumania
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Hunedoara, Rumania
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Iasi, Rumania
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Oradea, Rumania
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Piatra Neamt, Rumania
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Pitesti, Rumania
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Ploiesti, Rumania
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Ramnicu Valcea, Rumania
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Sibiu, Rumania
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Slatina, Rumania
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Suceava, Rumania
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Targoviste, Rumania
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Targu Mures, Rumania
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Timisoara, Rumania
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Zalau, Rumania
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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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Clinical outcomes (ischemic and bleeding) incidence and time to these clinical outcomes
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Antithrombotic treatments
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
|
Quality of life
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Mónica Tafalla, Medical Department.AstraZeneca Spain
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2010
Finalización primaria (Actual)
1 de marzo de 2013
Finalización del estudio (Actual)
1 de marzo de 2013
Fechas de registro del estudio
Enviado por primera vez
27 de julio de 2010
Primero enviado que cumplió con los criterios de control de calidad
27 de julio de 2010
Publicado por primera vez (Estimar)
28 de julio de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
17 de abril de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
16 de abril de 2013
Última verificación
1 de abril de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Isquemia
- Procesos Patológicos
- Necrosis
- Isquemia miocardica
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Dolor
- Manifestaciones neurológicas
- Enfermedad
- Enfermedad coronaria
- Dolor de pecho
- Angina de pecho
- Infarto de miocardio
- Infarto
- Enfermedad de la arteria coronaria
- Síndrome
- El síndrome coronario agudo
- Angina Inestable
Otros números de identificación del estudio
- NIS-CEU-DUM-2009/1
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .