Secondary Prevention of Cardiovascular Disease in the Elderly Trial

Phase 3

Completed

Conditions: Cardiovascular Disease
Myocardial Infarction

Interventions: Drug: Treatment Prevention for Secondary CV
Drug: Cardiovascular Polypill

Registration Number: NCT02596126

Lead Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2499

Inclusion Criteria

Patients diagnosed with a type 1 myocardial infarction within the previous 6 months.
Subjects must be ≥65 years old, presenting with at least one of the following additional conditions:
- Documented diabetes mellitus or previous treatment with oral hypoglycemic drugs or insulin.
- Mild to moderate renal dysfunction: creatinine clearance 60-30 mL/min/1.73 m2.
- Prior myocardial infarction: defined as an AMI occurring before the index event documented in a medical report.
- Prior coronary revascularization: coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).
- Prior stroke: history of a documented stroke, defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue, not resulting in death.
- Age ≥ 75 years.
Signing informed consent.

Exclusion Criteria

Unable to sign informed consent.
Contraindications to any of the components of the polypill.
Living in a nursing home.
Mental illness limiting the capacity of self-care.
Participating in another clinical trial.
Severe congestive heart failure (NYHA III-IV).
Severe renal disease (Creatinine Clearance (CrCl) <30ml/min/1.73 m2).
Need for oral anticoagulation at the time of randomization or planned in the future months.
Any condition limiting life expectancy <2 years, including but not limited to active malignancy.
Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation).
Scheduled coronary revascularization (patients can be randomized after final revascularization is completed within the prespecified timeframe).
Do not agree to the filing, forwarding and use of his/ her pseudonymised data.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Prevention for Secondary CV	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians..
Cardiovascular Polypill	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day.

Primary Outcome Measures

Name	Time	Method
Major Cardiovascular Adverse Events (MACE)	Up to 5 years	The incidence of the first occurrence of any component of the following composite endpoint, as adjudicated by the Clinical Events Committee: * Cardiovascular death. * Any nonfatal type 1 myocardial infarction. * Any nonfatal ischemic stroke. * Any urgent coronary revascularization not resulting in death.

Secondary Outcome Measures

Name	Time	Method
Efficacy Endpoints	24 months	Domain "Global satisfaction score" of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Global satisfaction score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).
Safety Endpoints	Up to 5 Years	The incidence of the first occurrence of the Non-cardiovascular death. Measured in number of cases.

Trial Locations

Locations (113): Hospital Universitario Rey Juan Carlos
🇪🇸
Móstoles, Madrid, Spain
Hospital Universitario QuironSalud Madrid
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Pozuelo De Alarcón, Madrid, Spain
Immanuel Klinikum Bernau Herzzentrum Brandenburg
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Bernau, Berlin, Germany
Brandenburgklinik Berlin-Brandenburg GmbH, Haus Brandenburg/ Kardiologie
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Waldsiedlung, Berlin, Germany
Medical Park Berlin Humboldtmühle
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Berlin - Tegel, Berlin, Germany
IOB-Policlinico San Marco
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Osio Sotto, BG, Italy
Ospedale Bolognini di Seriate - ASST BERGAMO EST
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Seriate, BG, Italy
Ospedale S.Lazzaro
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Alba, CN, Italy
ASL FG Ospedale "Teresa Masselli Mascia"
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San Severo, FG, Italy
Ospedale Misericordia ASL 9 Grosseto
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Grosseto, GR, Italy
Ospedale Sacro Cuore di Gesù
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Gallipoli, LE, Italy
ASST Di Monza-Presidio Ospedaliero di Desio
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Desio, MB, Italy
IRCCS Ospedale Policlinico di Milano
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Milano, MI, Italy
ASST Santi Paolo e Carlo-Ospedale San Paolo-Polo Univ.
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Milano, MI, Italy
IRCCS-Fondazione Don Carlo Gnocchi
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Milano, MI, Italy
IRCCS Istituto Clinico Humanitas
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Rozzano, MI, Italy
IRCCS Policlinico San Donato
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San Donato Milanese, MI, Italy
ASST Rhodense Ospedale di Passirana
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Passirana, Passirana-rho, Italy
Presidio Ospedaliero San Filippo Neri-ASL Roma E
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Roma, RM, Italy
A.O. San Camillo Forlanini
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Roma, RO, Italy
Ospedale Ss Giovanni di Dio e Ruggi d'Aragona
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Salerno, SA, Italy
Casa di Cura Villa Bianca
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Trento, TN, Italy
AAS3 "Alto Friuli, Collinare, Medio Friuli" Ospedale di San Daniele del Friuli-Tolmezzo sede di S. D. del Friuli
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San Daniele Del Friuli, UD, Italy
ASST Della Valle Olona-Ospedale di Saronno
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Saronno, VA, Italy
Vivantes Humboldt Klinikum
🇩🇪
Berlin, Germany
Hospital Universitari Vall D'hebron
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Barcelona, Spain
Hospital La Luz Quiron
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Madrid, Spain
Bács- Kiskun Megyei Kórház
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Kecskemét, Hungary
Sydó és Tsa Kft.
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Veszprém, Hungary
Hospital Univeristari de Bellvitge
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L'Hospitalet De Llobregat, Barcelona, Spain
IRCCS Fondazione S. Maugeri Istit. di Cassano Murge
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Cassano Delle Murge, BA, Italy
Ospedale Generale di Zona-Ospedale Valduce
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Como, CO, Italy
Fővárosi Szent János Kórház
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Budapest, Hungary
Hospital Universitario A Coruña
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A Coruña, Spain
C.H.U. Ruber Juan Bravo
🇪🇸
Madrid, Spain
Hospital General Universitario de Alicante
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Alicante, Spain
DRK- Kliniken Berlin/ Köpenick
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Berlin, Germany
Szent Rókus Kórház és Intézményei
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Budapest, Hungary
Békés Megyei Pándy Kálmán Kórház
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Gyula, Hungary
Fejér Megyei Szent György Egyetemi Kórház
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Székesfehérvár, Hungary
Samodzielny Publiczny Szpital Kliniczny nr 7, Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
🇵🇱
Katowice, Ochojec, Poland
ASST Degli Spedali Civili di Brescia
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Brescia, BS, Italy
Centro Cardiologico Monzino SpA
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Milano, MI, Italy
Ospedale di Sassuolo S.P.A.
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Sassuolo, MO, Italy
Uniwersyteckie Centrum Kliniczn
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Gdańsk, Poland
AVK Vivantes Rehabilitation GmbH
🇩🇪
Berlin, Germany
ASST di Bergamo Ovest-Ospedale di Treviglio
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Treviglio, BG, Italy
ASST Di Monza-Ospedale San Gerardo
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Monza, MB, Italy
GLG Fachklinik Wolletzsee GmbH
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Angermünde, Germany
H.C.U. Virgen De La Arrixaca De Murcia
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El Palmar, Murcia, Spain
Hospital Universitario Reina Sofia de Cordoba
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Córdoba, Spain
Klinik am See, Rehabilitationszentrum für innere Medizin
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Rüdersdorf, Brandenburg, Germany
Maria Heimsuchung Caritas-Klinik Pankow
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Berlin, Germany
Mediclin Reha-Zentrum Spreewald Fachklinik für innere Medizin
🇩🇪
Burg, Germany
MediClin Herzzentrum Coswig
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Coswig, Germany
Krakowski Szpital Specjalistyczny im. Jana Pawła II
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Kraków, Poland
Wojewódzki Szpital Specjalistyczny w Legnicy
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Legnica, Poland
Zespół Opieki Zdrowotnej w Kłodzku
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Kłodzko, Poland
Centrum Kardiologiczne "Pro Corde" Sp. z o.o.
🇵🇱
Wrocław, Poland
Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
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Wrocław, Poland
Samodzielny Publiczny Zespół Opieki Zdrowotnej w Świdnicy
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Świdnica, Poland
Hospital Universitario de Cabueñes
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Gijón, Asturias, Spain
Specjalistyczny Szpital im. Dra Alfreda Sokołowskiego
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Wałbrzych, Poland
Hospital Universitario y Politécnico de La Fe
🇪🇸
Valencia, Spain
Jüdisches Krankenhaus
🇩🇪
Berlin, Germany
Charité - Universitätsmedizin Berlin, Centrum für Schlaganfallforschung (CSB)
🇩🇪
Berlin, Germany
GK Havelhöhe
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Berlin, Germany
Gesundheitszentrum Bitterfeld /Wolfen GmbH
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Bitterfeld-Wolfen, Germany
DRK Klinik Berlin Westend
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Berlin, Germany
Hospital Universitario Principe de Asturias
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Alcalá De Henares, Madrid, Spain
H.C.U.de Santiago De Compostela
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Santiago De Compostela, Galicia, Spain
Hospital Universitario Infanta Elena
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Valdemoro, Madrid, Spain
Hospital Clinic de Barcelona
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Barcelona, Spain
Hospital Universitario La Princesa
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Madrid, Spain
Hospital General Universitario Gregorio Marañón
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Madrid, Spain
Hospital Universitario Clinico San Carlos
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Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
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Madrid, Spain
Hospital Universitario 12 de Octubre
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Madrid, Spain
Hospital Virgen de la Victoria
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Málaga, Spain
Complejo Asistencial Universitario de Salamanca
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Salamanca, Spain
Hospital Universitario Virgen Macarena
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Sevilla, Spain
Hospital Universitario Virgen del Rocio
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Sevilla, Spain
Szpital Wielospecjalistyczny im. Dr. Ludwika Błażka w Inowrocławiu
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Inowrocław, Poland
Vivantes Klinikum Spandu
🇩🇪
Berlin, Germany
Fakultní nemocnice Královské Vinohrady
🇨🇿
Praha, Praha 10, Czechia
Nemocnice Na Homolce
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Praha, Praha 5, Czechia
Nemocnice Rudolfa a Stefanie Benešov
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Benešov, Czechia
Všeobecná fakultní nemocnice v Praze
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Praha 2, Praha, Czechia
Fakultní nemocnice Olomouc
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Olomouc, Czechia
Nemocnice Jihlava
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Jihlava, Czechia
Krajská necmonice Liberec
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Liberec, Czechia
Nemocnice Slaný
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Slaný, Czechia
Nemocnice Podlesí
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Třinec, Czechia
Centre Hospitalier Universitaire d'Angers
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Angers, France
Centre Hospitalier Régional Universitaire de Besançon
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Besançon, France
Centre Hospitalier Universitaire de Caen
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Caen, France
Centre Hospitalier Universitaire de Lyon
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Bron, France
Centre Hospitalier Universitaire de Dijon
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Dijon, France
Centre Hospitalier Universitaire de Nice
🇫🇷
Nice, France
Centre Hospitalier Universitaire Henri Mondor
🇫🇷
Créteil, France
Centre Hospitalier Universitaire de Grenoble
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Grenoble, France
Centre Hospitalier Régional et Universitaire de Lille
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Lille, France
Hôpital Bichât
🇫🇷
Paris, France
Centre Hospitalier St Joseph St Luc
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Lyon, France
Centre hospitalier Universitaire de Bordeaux
🇫🇷
Pessac, France
Centre Hospitalier Universitaire de Toulouse
🇫🇷
Toulouse, France
Complejo Asistencial Universitario de Leon
🇪🇸
León, Leon, Spain
Hospital General de Villalba
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Collado-Villalba, Madrid, Spain
Hospital de Fuenlabrada
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Fuenlabrada, Madrid, Spain
Hospital Universitario Puerta de Hierro
🇪🇸
Majadahonda, Madrid, Spain
Hospital Clinic Universitari de Valencia
🇪🇸
Valencia, Spain
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
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Budapest, Hungary
Centre Hospitalier Metropole Savoie
🇫🇷
Chambéry, France