Secondary Prevention of Cardiovascular Disease in the Elderly Trial

NCT ID: NCT02596126

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2499 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2022-03-31

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

Conditions

Myocardial Infarction; Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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..

Group Type: ACTIVE_COMPARATOR

Treatment Prevention for Secondary CV

Intervention Type: DRUG

ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.

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.

Group Type: EXPERIMENTAL

Cardiovascular Polypill

Intervention Type: DRUG

Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril.

Participants will receive one of the following cardiovascular polypill:

(A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

or

(B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Interventions

Cardiovascular Polypill

Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril.

Participants will receive one of the following cardiovascular polypill:

(A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

or

(B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Intervention Type: DRUG

Treatment Prevention for Secondary CV

ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.

Intervention Type: DRUG

Other Intervention Names

Polypill; Antiplatelet agents; Lipid Lowering Agents; Renin-angiotensin-aldosterone system blockers

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: collaborator

Wroclaw Medical University

OTHER

Sponsor Role: collaborator

Semmelweis University

OTHER

Sponsor Role: collaborator

General University Hospital, Prague

OTHER

Sponsor Role: collaborator

Servicio Madrileño de Salud, Madrid, Spain

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

Ferrer Internacional S.A.

INDUSTRY

Sponsor Role: collaborator

Istituto Di Ricerche Farmacologiche Mario Negri

OTHER

Sponsor Role: collaborator

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valentin Fuster, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centro Nacional de Investigaciones Cardiovasculares Carlos III

Jose Maria Castellano Vazquez, MD, PhD

Role: STUDY_DIRECTOR

Centro Nacional de Investigaciones Cardiovasculares Carlos III

Locations

Všeobecná fakultní nemocnice v Praze

Prague, Prague, Czechia

Fakultní nemocnice Královské Vinohrady

Prague, Praha 10, Czechia

Nemocnice Na Homolce

Prague, Praha 5, 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

Klinik am See, Rehabilitationszentrum für innere Medizin

Rüdersdorf, Brandenburg, Germany

Immanuel Klinikum Bernau Herzzentrum Brandenburg

Bernau, State of Berlin, Germany

Medical Park Berlin Humboldtmühle

Tegel, State of Berlin, Germany

Brandenburgklinik Berlin-Brandenburg GmbH, Haus Brandenburg/ Kardiologie

Waldsiedlung, State of Berlin, 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

Milan, MI, Italy

Centro Cardiologico Monzino SpA

Milan, MI, Italy

ASST Santi Paolo e Carlo-Ospedale San Paolo-Polo Univ.

Milan, MI, Italy

IRCCS-Fondazione Don Carlo Gnocchi

Milan, 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

Gdansk, , Poland

Szpital Wielospecjalistyczny im. Dr. Ludwika Błażka w Inowrocławiu

Inowrocław, , Poland

Krakowski Szpital Specjalistyczny im. Jana Pawła II

Krakow, , Poland

Zespół Opieki Zdrowotnej w Kłodzku

Kłodzko, , Poland

Wojewódzki Szpital Specjalistyczny w Legnicy

Legnica, , Poland

Samodzielny Publiczny Zespół Opieki Zdrowotnej w Świdnicy

Swidnica, , Poland

Specjalistyczny Szpital im. Dra Alfreda Sokołowskiego

Wałbrzych, , Poland

Centrum Kardiologiczne "Pro Corde" Sp. z o.o.

Wroclaw, , Poland

Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ

Wroclaw, , Poland

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 de Cabueñes

Gijón, Principality of Asturias, 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

Seville, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Clinic Universitari de Valencia

Valencia, , Spain

Hospital Universitario y Politécnico de La Fe

Valencia, , Spain

Countries

Czechia; France; Germany; Hungary; Italy; Poland; Spain

References

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.

Reference Type: DERIVED

PMID: 36018037 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34324628 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2015-002868-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

633765

Identifier Type: -

Identifier Source: org_study_id