Clinical trial NCT02596126: Secondary Prevention of Cardiovascular Disease in the Elderly Trial
Official title: Secondary Prevention of Cardiovascular Disease in the Elderly Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Cardiovascular Disease
Keywords: Polypill
Prevention of Secondary Cardiovascular Disease
Cardiovascular Disease
Myocardial Infarction
Cardiovascular Combination Polypill AAR
Cardiovascular Disease in the Elderly
Adherence
SECURE
Elderly
Secondary Cardiovascular Disease
Secondary Cardiovascular Prevention
Randomized Cardiovascular Trial
Randomized Trial
Cardiovascular Polypill
Lead sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Centre Hospitalier Universitaire de Besancon
name: Wroclaw Medical University
name: Semmelweis University
name: General University Hospital, Prague
name: Servicio Madrileño de Salud, Madrid, Spain
name: London School of Hygiene and Tropical Medicine
name: Ferrer Internacional S.A.
name: Istituto Di Ricerche Farmacologiche Mario Negri
First posted: 2015-11-04
Enrollment: 2499
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with a type 1 myocardial infarction within the previous 6 months.
2. 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.
3. Signing informed consent.

Exclusion Criteria:

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

Primary outcomes:
measure: Major Cardiovascular Adverse Events (MACE)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Efficacy Endpoints
timeFrame: 6 months
measure: Safety Endpoints
timeFrame: Up to 5 Years
measure: Efficacy Endpoints
timeFrame: 2 years
measure: Efficacy Endpoints
timeFrame: 6 months
measure: Efficacy Endpoints
timeFrame: 12 months
measure: Efficacy Endpoints
timeFrame: 2 years
measure: Efficacy Endpoints
timeFrame: 6 months
measure: Efficacy Endpoints
timeFrame: 12 months
measure: Efficacy Endpoints
timeFrame: 2 years
measure: Efficacy Endpoints
timeFrame: 12 months
measure: Efficacy Endpoints
timeFrame: 2 years
measure: Efficacy Endpoints
timeFrame: Up to 5 years
measure: Efficacy Endpoints
timeFrame: Up to 5 years
measure: Efficacy Endpoints
timeFrame: Up to 5 years
measure: Efficacy Endpoints
timeFrame: Up to 5 years
measure: Efficacy Endpoints
timeFrame: Up to 5 years
measure: Efficacy Endpoints
timeFrame: 6 months
measure: Efficacy Endpoints
timeFrame: 6 months
measure: Efficacy Endpoints
timeFrame: 6 months
measure: Efficacy Endpoints
timeFrame: 6 months
measure: Efficacy Endpoints
timeFrame: 24 months
measure: Efficacy Endpoints
timeFrame: 24 months
measure: Efficacy Endpoints
timeFrame: 24 months
measure: Efficacy Endpoints
timeFrame: 24 months
measure: Safety Endpoints
timeFrame: Up to 5 Years
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Fakultní nemocnice Královské Vinohrady
state: Praha 10
city: Praha
country: Czechia
facility: Nemocnice Na Homolce
state: Praha 5
city: Praha 2
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
state: Praha
city: Benešov
country: Czechia
facility: Nemocnice Rudolfa a Stefanie Benešov
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava
city: Liberec
country: Czechia
facility: Krajská necmonice Liberec
city: Olomouc
country: Czechia
facility: Fakultní nemocnice Olomouc
city: Slaný
country: Czechia
facility: Nemocnice Slaný
city: Třinec
country: Czechia
facility: Nemocnice Podlesí
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon
city: Bron
country: France
facility: Centre Hospitalier Universitaire de Lyon
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen
city: Chambéry
country: France
facility: Centre Hospitalier Metropole Savoie
city: Créteil
country: France
facility: Centre Hospitalier Universitaire Henri Mondor
city: Dijon
country: France
facility: Centre Hospitalier Universitaire de Dijon
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble
city: Lille
country: France
facility: Centre Hospitalier Régional et Universitaire de Lille
city: Lyon
country: France
facility: Centre Hospitalier St Joseph St Luc
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice
city: Paris
country: France
facility: Hôpital Bichât
city: Pessac
country: France
facility: Centre hospitalier Universitaire de Bordeaux
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
city: Berlin - Tegel
country: Germany
facility: Medical Park Berlin Humboldtmühle
state: Berlin
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg
state: Berlin
city: Waldsiedlung
country: Germany
facility: Brandenburgklinik Berlin-Brandenburg GmbH, Haus Brandenburg/ Kardiologie
state: Berlin
city: Rüdersdorf
country: Germany
facility: Klinik am See, Rehabilitationszentrum für innere Medizin
state: Brandenburg
city: Angermünde
country: Germany
facility: GLG Fachklinik Wolletzsee GmbH
city: Berlin
country: Germany
facility: AVK Vivantes Rehabilitation GmbH
city: Berlin
country: Germany
facility: DRK- Kliniken Berlin/ Köpenick
city: Berlin
country: Germany
facility: Maria Heimsuchung Caritas-Klinik Pankow
city: Berlin
country: Germany
facility: Jüdisches Krankenhaus
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Centrum für Schlaganfallforschung (CSB)
city: Berlin
country: Germany
facility: Vivantes Humboldt Klinikum
city: Berlin
country: Germany
facility: Vivantes Klinikum Spandu
city: Berlin
country: Germany
facility: DRK Klinik Berlin Westend
city: Berlin
country: Germany
facility: GK Havelhöhe
city: Bitterfeld-Wolfen
country: Germany
facility: Gesundheitszentrum Bitterfeld /Wolfen GmbH
city: Burg
country: Germany
facility: Mediclin Reha-Zentrum Spreewald Fachklinik für innere Medizin
city: Coswig
country: Germany
facility: MediClin Herzzentrum Coswig
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
city: Budapest
country: Hungary
facility: Fővárosi Szent János Kórház
city: Budapest
country: Hungary
facility: Szent Rókus Kórház és Intézményei
city: Gyula
country: Hungary
facility: Békés Megyei Pándy Kálmán Kórház
city: Kecskemét
country: Hungary
facility: Bács- Kiskun Megyei Kórház
city: Székesfehérvár
country: Hungary
facility: Fejér Megyei Szent György Egyetemi Kórház
city: Veszprém
country: Hungary
facility: Sydó és Tsa Kft.
city: Cassano Delle Murge
country: Italy
facility: IRCCS Fondazione S. Maugeri Istit. di Cassano Murge
state: BA
city: Osio Sotto
country: Italy
facility: IOB-Policlinico San Marco
state: BG
city: Seriate
country: Italy
facility: Ospedale Bolognini di Seriate - ASST BERGAMO EST
state: BG
city: Treviglio
country: Italy
facility: ASST di Bergamo Ovest-Ospedale di Treviglio
state: BG
city: Brescia
country: Italy
facility: ASST Degli Spedali Civili di Brescia
state: BS
city: Alba
country: Italy
facility: Ospedale S.Lazzaro
state: CN
city: Como
country: Italy
facility: Ospedale Generale di Zona-Ospedale Valduce
state: CO
city: San Severo
country: Italy
facility: ASL FG Ospedale "Teresa Masselli Mascia"
state: FG
city: Grosseto
country: Italy
facility: Ospedale Misericordia ASL 9 Grosseto
state: GR
city: Gallipoli
country: Italy
facility: Ospedale Sacro Cuore di Gesù
state: LE
city: Desio
country: Italy
facility: ASST Di Monza-Presidio Ospedaliero di Desio
state: MB
city: Monza
country: Italy
facility: ASST Di Monza-Ospedale San Gerardo
state: MB
city: Milano
country: Italy
facility: IRCCS Ospedale Policlinico di Milano
state: MI
city: Milano
country: Italy
facility: Centro Cardiologico Monzino SpA
state: MI
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo-Ospedale San Paolo-Polo Univ.
state: MI
city: Milano
country: Italy
facility: IRCCS-Fondazione Don Carlo Gnocchi
state: MI
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
state: MI
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: MI
city: Sassuolo
country: Italy
facility: Ospedale di Sassuolo S.P.A.
state: MO
city: Passirana
country: Italy
facility: ASST Rhodense Ospedale di Passirana
state: Passirana-rho
city: Roma
country: Italy
facility: Presidio Ospedaliero San Filippo Neri-ASL Roma E
state: RM
city: Roma
country: Italy
facility: A.O. San Camillo Forlanini
state: RO
city: Salerno
country: Italy
facility: Ospedale Ss Giovanni di Dio e Ruggi d'Aragona
state: SA
city: Trento
country: Italy
facility: Casa di Cura Villa Bianca
state: TN
city: San Daniele Del Friuli
country: Italy
facility: AAS3 "Alto Friuli, Collinare, Medio Friuli" Ospedale di San Daniele del Friuli-Tolmezzo sede di S. D. del Friuli
state: UD
city: Saronno
country: Italy
facility: ASST Della Valle Olona-Ospedale di Saronno
state: VA
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 7, Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
state: Ochojec
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczn
city: Inowrocław
country: Poland
facility: Szpital Wielospecjalistyczny im. Dr. Ludwika Błażka w Inowrocławiu
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II
city: Kłodzko
country: Poland
facility: Zespół Opieki Zdrowotnej w Kłodzku
city: Legnica
country: Poland
facility: Wojewódzki Szpital Specjalistyczny w Legnicy
city: Wałbrzych
country: Poland
facility: Specjalistyczny Szpital im. Dra Alfreda Sokołowskiego
city: Wrocław
country: Poland
facility: Centrum Kardiologiczne "Pro Corde" Sp. z o.o.
city: Wrocław
country: Poland
facility: Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
city: Świdnica
country: Poland
facility: Samodzielny Publiczny Zespół Opieki Zdrowotnej w Świdnicy
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
state: Asturias
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Univeristari de Bellvitge
state: Barcelona
city: Santiago De Compostela
country: Spain
facility: H.C.U.de Santiago De Compostela
state: Galicia
city: León
country: Spain
facility: Complejo Asistencial Universitario de Leon
state: Leon
city: Alcalá De Henares
country: Spain
facility: Hospital Universitario Principe de Asturias
state: Madrid
city: Collado-Villalba
country: Spain
facility: Hospital General de Villalba
state: Madrid
city: Fuenlabrada
country: Spain
facility: Hospital de Fuenlabrada
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Universitario Rey Juan Carlos
state: Madrid
city: Pozuelo De Alarcón
country: Spain
facility: Hospital Universitario QuironSalud Madrid
state: Madrid
city: Valdemoro
country: Spain
facility: Hospital Universitario Infanta Elena
state: Madrid
city: El Palmar
country: Spain
facility: H.C.U. Virgen De La Arrixaca De Murcia
state: Murcia
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia de Cordoba
city: Madrid
country: Spain
facility: Hospital La Luz Quiron
city: Madrid
country: Spain
facility: C.H.U. Ruber Juan Bravo
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clinic Universitari de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico de La Fe
Study officials:
affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III
name: Valentin Fuster, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III
name: Jose Maria Castellano Vazquez, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Castellano JM, Pocock SJ, Bhatt DL, Quesada AJ, Owen R, Fernandez-Ortiz A, Sanchez PL, Marin Ortuno F, Vazquez Rodriguez JM, Domingo-Fernandez A, Lozano I, Roncaglioni MC, Baviera M, Foresta A, Ojeda-Fernandez L, Colivicchi F, Di Fusco SA, Doehner W, Meyer A, Schiele F, Ecarnot F, Linhart A, Lubanda JC, Barczi G, Merkely B, Ponikowski P, Kasprzak M, Fernandez Alvira JM, Andres V, Bueno H, Collier T, Van de Werf F, Perel P, Rodriguez-Manero M, Alonso Garcia A, Proietti M, Schoos MM, Simon T, Fernandez Ferro J, Lopez N, Beghi E, Bejot Y, Vivas D, Cordero A, Ibanez B, Fuster V; SECURE Investigators. Polypill Strategy in Secondary Cardiovascular Prevention. N Engl J Med. 2022 Sep 15;387(11):967-977. doi: 10.1056/NEJMoa2208275. Epub 2022 Aug 26.
citation: Buttgereit T, Palmowski A, Forsat N, Boers M, Witham MD, Rodondi N, Moutzouri E, Navidad AJQ, Van't Hof AWJ, van der Worp B, Coll-Planas L, Voshaar M, de Wit M, da Silva J, Stegemann S, Bijlsma JW, Koeller M, Mooijaart S, Kearney PM, Buttgereit F. Barriers and potential solutions in the recruitment and retention of older patients in clinical trials-lessons learned from six large multicentre randomized controlled trials. Age Ageing. 2021 Nov 10;50(6):1988-1996. doi: 10.1093/ageing/afab147.