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Brief Title: Secondary Prevention of Cardiovascular Disease in the Elderly Trial
Official Title: Secondary Prevention of Cardiovascular Disease in the Elderly Trial
Study ID: NCT02596126
Brief Summary: The purpose of this study is to evaluate the efficacy of a polypill strategy containing aspirin (100 mg), ramipril (2.5, 5 or 10 mgs), and atorvastatin (40 mgs) compared with the standard of care (usual care according to the local clinical practices at each participating country) in secondary prevention of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in elderly patients with a recent myocardial infarction.
Detailed Description: A total number of 2499 patients have been randomized (1:1) to treatment arms. Patients will be recruited across seven countries in Europe (Spain, Italy, Germany, France, Hungary, Poland, and Czech Republic). Patients will be ≥65 years old and diagnosed with a type 1 myocardial infarction within 6 months prior to study enrolment. Once the inclusion and exclusion criteria are confirmed, patients will be included in the study after signing informed consent. Randomization will take place within 6 months of the index event (AMI type I) in a 1:1 ratio to one of the two arms: * Cardiovascular Polypill (containing Aspirin, Ramipril, and Atorvastatin) * Usual care Patients will be followed up for a minimum of 2 years and a maximum of 5 years. There will be 3 follow up visits at month 6, 12 and 24 and telephone follow up calls at month 18, 36, 48 and 60
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fakultní nemocnice Královské Vinohrady, Praha, Praha 10, Czechia
Nemocnice Na Homolce, Praha, Praha 5, Czechia
Všeobecná fakultní nemocnice v Praze, Praha 2, Praha, Czechia
Nemocnice Rudolfa a Stefanie Benešov, Benešov, , Czechia
Nemocnice Jihlava, Jihlava, , Czechia
Krajská necmonice Liberec, Liberec, , Czechia
Fakultní nemocnice Olomouc, Olomouc, , Czechia
Nemocnice Slaný, Slaný, , Czechia
Nemocnice Podlesí, Třinec, , Czechia
Centre Hospitalier Universitaire d'Angers, Angers, , France
Centre Hospitalier Régional Universitaire de Besançon, Besançon, , France
Centre Hospitalier Universitaire de Lyon, Bron, , France
Centre Hospitalier Universitaire de Caen, Caen, , France
Centre Hospitalier Metropole Savoie, Chambéry, , France
Centre Hospitalier Universitaire Henri Mondor, Créteil, , France
Centre Hospitalier Universitaire de Dijon, Dijon, , France
Centre Hospitalier Universitaire de Grenoble, Grenoble, , France
Centre Hospitalier Régional et Universitaire de Lille, Lille, , France
Centre Hospitalier St Joseph St Luc, Lyon, , France
Centre Hospitalier Universitaire de Nice, Nice, , France
Hôpital Bichât, Paris, , France
Centre hospitalier Universitaire de Bordeaux, Pessac, , France
Centre Hospitalier Universitaire de Toulouse, Toulouse, , France
Medical Park Berlin Humboldtmühle, Berlin - Tegel, Berlin, Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg, Bernau, Berlin, Germany
Brandenburgklinik Berlin-Brandenburg GmbH, Haus Brandenburg/ Kardiologie, Waldsiedlung, Berlin, Germany
Klinik am See, Rehabilitationszentrum für innere Medizin, Rüdersdorf, Brandenburg, Germany
GLG Fachklinik Wolletzsee GmbH, Angermünde, , Germany
AVK Vivantes Rehabilitation GmbH, Berlin, , Germany
DRK- Kliniken Berlin/ Köpenick, Berlin, , Germany
Maria Heimsuchung Caritas-Klinik Pankow, Berlin, , Germany
Jüdisches Krankenhaus, Berlin, , Germany
Charité - Universitätsmedizin Berlin, Centrum für Schlaganfallforschung (CSB), Berlin, , Germany
Vivantes Humboldt Klinikum, Berlin, , Germany
Vivantes Klinikum Spandu, Berlin, , Germany
DRK Klinik Berlin Westend, Berlin, , Germany
GK Havelhöhe, Berlin, , Germany
Gesundheitszentrum Bitterfeld /Wolfen GmbH, Bitterfeld-Wolfen, , Germany
Mediclin Reha-Zentrum Spreewald Fachklinik für innere Medizin, Burg, , Germany
MediClin Herzzentrum Coswig, Coswig, , Germany
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika, Budapest, , Hungary
Fővárosi Szent János Kórház, Budapest, , Hungary
Szent Rókus Kórház és Intézményei, Budapest, , Hungary
Békés Megyei Pándy Kálmán Kórház, Gyula, , Hungary
Bács- Kiskun Megyei Kórház, Kecskemét, , Hungary
Fejér Megyei Szent György Egyetemi Kórház, Székesfehérvár, , Hungary
Sydó és Tsa Kft., Veszprém, , Hungary
IRCCS Fondazione S. Maugeri Istit. di Cassano Murge, Cassano Delle Murge, BA, Italy
IOB-Policlinico San Marco, Osio Sotto, BG, Italy
Ospedale Bolognini di Seriate - ASST BERGAMO EST, Seriate, BG, Italy
ASST di Bergamo Ovest-Ospedale di Treviglio, Treviglio, BG, Italy
ASST Degli Spedali Civili di Brescia, Brescia, BS, Italy
Ospedale S.Lazzaro, Alba, CN, Italy
Ospedale Generale di Zona-Ospedale Valduce, Como, CO, Italy
ASL FG Ospedale "Teresa Masselli Mascia", San Severo, FG, Italy
Ospedale Misericordia ASL 9 Grosseto, Grosseto, GR, Italy
Ospedale Sacro Cuore di Gesù, Gallipoli, LE, Italy
ASST Di Monza-Presidio Ospedaliero di Desio, Desio, MB, Italy
ASST Di Monza-Ospedale San Gerardo, Monza, MB, Italy
IRCCS Ospedale Policlinico di Milano, Milano, MI, Italy
Centro Cardiologico Monzino SpA, Milano, MI, Italy
ASST Santi Paolo e Carlo-Ospedale San Paolo-Polo Univ., Milano, MI, Italy
IRCCS-Fondazione Don Carlo Gnocchi, Milano, MI, Italy
IRCCS Istituto Clinico Humanitas, Rozzano, MI, Italy
IRCCS Policlinico San Donato, San Donato Milanese, MI, Italy
Ospedale di Sassuolo S.P.A., Sassuolo, MO, Italy
ASST Rhodense Ospedale di Passirana, Passirana, Passirana-rho, Italy
Presidio Ospedaliero San Filippo Neri-ASL Roma E, Roma, RM, Italy
A.O. San Camillo Forlanini, Roma, RO, Italy
Ospedale Ss Giovanni di Dio e Ruggi d'Aragona, Salerno, SA, Italy
Casa di Cura Villa Bianca, Trento, TN, Italy
AAS3 "Alto Friuli, Collinare, Medio Friuli" Ospedale di San Daniele del Friuli-Tolmezzo sede di S. D. del Friuli, San Daniele Del Friuli, UD, Italy
ASST Della Valle Olona-Ospedale di Saronno, Saronno, VA, Italy
Samodzielny Publiczny Szpital Kliniczny nr 7, Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca, Katowice, Ochojec, Poland
Uniwersyteckie Centrum Kliniczn, Gdańsk, , Poland
Szpital Wielospecjalistyczny im. Dr. Ludwika Błażka w Inowrocławiu, Inowrocław, , Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II, Kraków, , Poland
Zespół Opieki Zdrowotnej w Kłodzku, Kłodzko, , Poland
Wojewódzki Szpital Specjalistyczny w Legnicy, Legnica, , Poland
Specjalistyczny Szpital im. Dra Alfreda Sokołowskiego, Wałbrzych, , Poland
Centrum Kardiologiczne "Pro Corde" Sp. z o.o., Wrocław, , Poland
Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ, Wrocław, , Poland
Samodzielny Publiczny Zespół Opieki Zdrowotnej w Świdnicy, Świdnica, , Poland
Hospital Universitario de Cabueñes, Gijón, Asturias, Spain
Hospital Univeristari de Bellvitge, L'Hospitalet De Llobregat, Barcelona, Spain
H.C.U.de Santiago De Compostela, Santiago De Compostela, Galicia, Spain
Complejo Asistencial Universitario de Leon, León, Leon, Spain
Hospital Universitario Principe de Asturias, Alcalá De Henares, Madrid, Spain
Hospital General de Villalba, Collado-Villalba, Madrid, Spain
Hospital de Fuenlabrada, Fuenlabrada, Madrid, Spain
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
Hospital Universitario Rey Juan Carlos, Móstoles, Madrid, Spain
Hospital Universitario QuironSalud Madrid, Pozuelo De Alarcón, Madrid, Spain
Hospital Universitario Infanta Elena, Valdemoro, Madrid, Spain
H.C.U. Virgen De La Arrixaca De Murcia, El Palmar, Murcia, Spain
Hospital Universitario A Coruña, A Coruña, , Spain
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital Universitari Vall D'hebron, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Universitario Reina Sofia de Cordoba, Córdoba, , Spain
Hospital La Luz Quiron, Madrid, , Spain
C.H.U. Ruber Juan Bravo, Madrid, , Spain
Hospital Universitario La Princesa, Madrid, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario Clinico San Carlos, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Virgen de la Victoria, Málaga, , Spain
Complejo Asistencial Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Clinic Universitari de Valencia, Valencia, , Spain
Hospital Universitario y Politécnico de La Fe, Valencia, , Spain
Name: Valentin Fuster, MD, PhD
Affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III
Role: PRINCIPAL_INVESTIGATOR
Name: Jose Maria Castellano Vazquez, MD, PhD
Affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III
Role: STUDY_DIRECTOR