Secondary Prevention of Cardiovascular Disease in the Elderly Trial
SECURE
2 other identifiers
interventional
2,499
7 countries
113
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2016
Longer than P75 for phase_3
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 4, 2015
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedResults Posted
Study results publicly available
May 23, 2025
CompletedMay 23, 2025
August 1, 2021
5.3 years
October 5, 2015
November 4, 2024
May 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Cardiovascular Adverse Events (MACE)
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.
Up to 5 years
Secondary Outcomes (25)
Efficacy Endpoints
6 months
Safety Endpoints
Up to 5 Years
Efficacy Endpoints
2 years
Efficacy Endpoints
6 months
Efficacy Endpoints
12 months
- +20 more secondary outcomes
Study Arms (2)
Treatment Prevention for Secondary CV
ACTIVE COMPARATORPatients 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
EXPERIMENTALPatients 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.
Interventions
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).
ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos IIIlead
- Charite University, Berlin, Germanycollaborator
- Centre Hospitalier Universitaire de Besanconcollaborator
- Wroclaw Medical Universitycollaborator
- Semmelweis Universitycollaborator
- General University Hospital, Praguecollaborator
- Servicio Madrileño de Salud, Madrid, Spaincollaborator
- London School of Hygiene and Tropical Medicinecollaborator
- Ferrer Internacional S.A.collaborator
- Istituto Di Ricerche Farmacologiche Mario Negricollaborator
Study Sites (113)
Všeobecná fakultní nemocnice v Praze
Prague, Prague, 12808, Czechia
Fakultní nemocnice Královské Vinohrady
Prague, Praha 10, 10034, Czechia
Nemocnice Na Homolce
Prague, Praha 5, 15030, Czechia
Nemocnice Rudolfa a Stefanie Benešov
Benešov, 25601, Czechia
Nemocnice Jihlava
Jihlava, 58633, Czechia
Krajská necmonice Liberec
Liberec, 46030, Czechia
Fakultní nemocnice Olomouc
Olomouc, 77900, Czechia
Nemocnice Slaný
Slaný, 27401, Czechia
Nemocnice Podlesí
Třinec, 73961, Czechia
Centre Hospitalier Universitaire d'Angers
Angers, 49933, France
Centre Hospitalier Régional Universitaire de Besançon
Besançon, 25030, France
Centre Hospitalier Universitaire de Lyon
Bron, 69500, France
Centre Hospitalier Universitaire de Caen
Caen, 14000, France
Centre Hospitalier Metropole Savoie
Chambéry, 73000, France
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94000, France
Centre Hospitalier Universitaire de Dijon
Dijon, 21000, France
Centre Hospitalier Universitaire de Grenoble
Grenoble, 38000, France
Centre Hospitalier Régional et Universitaire de Lille
Lille, 59037, France
Centre Hospitalier St Joseph St Luc
Lyon, 69365, France
Centre Hospitalier Universitaire de Nice
Nice, 06002, France
Hôpital Bichât
Paris, 75010, France
Centre hospitalier Universitaire de Bordeaux
Pessac, 33604, France
Centre Hospitalier Universitaire de Toulouse
Toulouse, 31403, France
Klinik am See, Rehabilitationszentrum für innere Medizin
Rüdersdorf, Brandenburg, 15562, Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, State of Berlin, 16321, Germany
Medical Park Berlin Humboldtmühle
Tegel, State of Berlin, 13507, Germany
Brandenburgklinik Berlin-Brandenburg GmbH, Haus Brandenburg/ Kardiologie
Waldsiedlung, State of Berlin, 16321, Germany
GLG Fachklinik Wolletzsee GmbH
Angermünde, 16278, Germany
AVK Vivantes Rehabilitation GmbH
Berlin, 12157, Germany
DRK- Kliniken Berlin/ Köpenick
Berlin, 12559, Germany
Maria Heimsuchung Caritas-Klinik Pankow
Berlin, 13187, Germany
Jüdisches Krankenhaus
Berlin, 13347, Germany
Charité - Universitätsmedizin Berlin, Centrum für Schlaganfallforschung (CSB)
Berlin, 13353, Germany
Vivantes Humboldt Klinikum
Berlin, 13509, Germany
Vivantes Klinikum Spandu
Berlin, 13585, Germany
DRK Klinik Berlin Westend
Berlin, 14050, Germany
GK Havelhöhe
Berlin, 14089, Germany
Gesundheitszentrum Bitterfeld /Wolfen GmbH
Bitterfeld-Wolfen, 06749, Germany
Mediclin Reha-Zentrum Spreewald Fachklinik für innere Medizin
Burg, 03096, Germany
MediClin Herzzentrum Coswig
Coswig, 06869, Germany
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
Budapest, 1122, Hungary
Fővárosi Szent János Kórház
Budapest, 1125, Hungary
Szent Rókus Kórház és Intézményei
Budapest, H-1085, Hungary
Békés Megyei Pándy Kálmán Kórház
Gyula, 5700, Hungary
Bács- Kiskun Megyei Kórház
Kecskemét, 6000, Hungary
Fejér Megyei Szent György Egyetemi Kórház
Székesfehérvár, 8000, Hungary
Sydó és Tsa Kft.
Veszprém, H-8200, Hungary
IRCCS Fondazione S. Maugeri Istit. di Cassano Murge
Cassano delle Murge, BA, 70020, Italy
IOB-Policlinico San Marco
Osio Sotto, BG, 24040, Italy
Ospedale Bolognini di Seriate - ASST BERGAMO EST
Seriate, BG, 24068, Italy
ASST di Bergamo Ovest-Ospedale di Treviglio
Treviglio, BG, 24047, Italy
ASST Degli Spedali Civili di Brescia
Brescia, BS, 25123, Italy
Ospedale S.Lazzaro
Alba, CN, 12051, Italy
Ospedale Generale di Zona-Ospedale Valduce
Como, CO, 22100, Italy
ASL FG Ospedale "Teresa Masselli Mascia"
San Severo, FG, 71016, Italy
Ospedale Misericordia ASL 9 Grosseto
Grosseto, GR, 58100, Italy
Ospedale Sacro Cuore di Gesù
Gallipoli, LE, 73014, Italy
ASST Di Monza-Presidio Ospedaliero di Desio
Desio, MB, 20832, Italy
ASST Di Monza-Ospedale San Gerardo
Monza, MB, 20900, Italy
IRCCS Ospedale Policlinico di Milano
Milan, MI, 20122, Italy
Centro Cardiologico Monzino SpA
Milan, MI, 20138, Italy
ASST Santi Paolo e Carlo-Ospedale San Paolo-Polo Univ.
Milan, MI, 20142, Italy
IRCCS-Fondazione Don Carlo Gnocchi
Milan, MI, 20149, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, MI, 20089, Italy
IRCCS Policlinico San Donato
San Donato Milanese, MI, 20097, Italy
Ospedale di Sassuolo S.P.A.
Sassuolo, MO, 41049, Italy
ASST Rhodense Ospedale di Passirana
Passirana, Passirana-rho, 20017, Italy
Presidio Ospedaliero San Filippo Neri-ASL Roma E
Roma, RM, 00135, Italy
A.O. San Camillo Forlanini
Roma, RO, 00149, Italy
Ospedale Ss Giovanni di Dio e Ruggi d'Aragona
Salerno, SA, 84131, Italy
Casa di Cura Villa Bianca
Trento, TN, 38122, 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, 33038, Italy
ASST Della Valle Olona-Ospedale di Saronno
Saronno, VA, 21047, Italy
Samodzielny Publiczny Szpital Kliniczny nr 7, Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
Katowice, Ochojec, 40-635, Poland
Uniwersyteckie Centrum Kliniczn
Gdansk, 80-952, Poland
Szpital Wielospecjalistyczny im. Dr. Ludwika Błażka w Inowrocławiu
Inowrocław, 88-100, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, 31-202, Poland
Zespół Opieki Zdrowotnej w Kłodzku
Kłodzko, 57-300, Poland
Wojewódzki Szpital Specjalistyczny w Legnicy
Legnica, 59-220, Poland
Samodzielny Publiczny Zespół Opieki Zdrowotnej w Świdnicy
Swidnica, 58-100, Poland
Specjalistyczny Szpital im. Dra Alfreda Sokołowskiego
Wałbrzych, 58-309, Poland
Centrum Kardiologiczne "Pro Corde" Sp. z o.o.
Wroclaw, 50-315, Poland
Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Wroclaw, 50-981, Poland
Hospital Univeristari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08997, Spain
H.C.U.de Santiago De Compostela
Santiago de Compostela, Galicia, 15706, Spain
Complejo Asistencial Universitario de Leon
León, Leon, 24008, Spain
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, 28805, Spain
Hospital General de Villalba
Collado Villalba, Madrid, 28400, Spain
Hospital de Fuenlabrada
Fuenlabrada, Madrid, 28492, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28933, Spain
Hospital Universitario QuironSalud Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Universitario Infanta Elena
Valdemoro, Madrid, 28340, Spain
H.C.U. Virgen De La Arrixaca De Murcia
El Palmar, Murcia, 30120, Spain
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, 33203, Spain
Hospital Universitario A Coruña
A Coruña, 15006, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Universitari Vall D'hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Reina Sofia de Cordoba
Córdoba, 14004, Spain
Hospital La Luz Quiron
Madrid, 28003, Spain
C.H.U. Ruber Juan Bravo
Madrid, 28006, Spain
Hospital Universitario La Princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28009, Spain
Hospital Universitario Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Virgen de la Victoria
Málaga, 29010, Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Clinic Universitari de Valencia
Valencia, 46010, Spain
Hospital Universitario y Politécnico de La Fe
Valencia, 46026, Spain
Related Publications (2)
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.
PMID: 36018037DERIVEDButtgereit 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.
PMID: 34324628DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Antonio J Quesada, PhD
- Organization
- Centro Nacional de Investigaciones Cardiovasculares Carlos III F.S.P (CNIC)
Study Officials
- PRINCIPAL INVESTIGATOR
Valentin Fuster, MD, PhD
Centro Nacional de Investigaciones Cardiovasculares Carlos III
- STUDY DIRECTOR
Jose Maria Castellano Vazquez, MD, PhD
Centro Nacional de Investigaciones Cardiovasculares Carlos III
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2015
First Posted
November 4, 2015
Study Start
July 1, 2016
Primary Completion
October 31, 2021
Study Completion
March 31, 2022
Last Updated
May 23, 2025
Results First Posted
May 23, 2025
Record last verified: 2021-08