Secondary Prevention of Cardiovascular Disease in the Elderly Trial (SECURE)

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Cardiovascular Disease
• Intervention / Treatment: Drug: Treatment Prevention for Secondary CV; Drug: Cardiovascular Polypill

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

• Study Type: Interventional
• Enrollment (Actual): 2499
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Benešov, Czechia, 25601
    • Nemocnice Rudolfa a Stefanie Benešov
  • Jihlava, Czechia, 58633
    • Nemocnice Jihlava
  • Liberec, Czechia, 46030
    • Krajská necmonice Liberec
  • Olomouc, Czechia, 77900
    • Fakultni nemocnice Olomouc
  • Slaný, Czechia, 27401
    • Nemocnice Slany
  • Třinec, Czechia, 73961
    • Nemocnice Podlesi
  • Praha
    • Praha 2, Praha, Czechia, 12808
      • Vseobecna Fakultni Nemocnice V Praze
  • Praha 10
    • Praha, Praha 10, Czechia, 10034
      • Fakultní Nemocnice Královské Vinohrady
  • Praha 5
    • Praha, Praha 5, Czechia, 15030
      • Nemocnice Na Homolce
• France
  • Angers, France, 49933
    • Centre Hospitalier Universitaire d'Angers
  • Besançon, France, 25030
    • Centre Hospitalier Régional Universitaire de Besançon
  • Bron, France, 69500
    • Centre Hospitalier Universitaire de Lyon
  • Caen, France, 14000
    • Centre Hospitalier Universitaire de Caen
  • Chambéry, France, 73000
    • Centre Hospitalier Metropole Savoie
  • Créteil, France, 94000
    • Centre Hospitalier Universitaire Henri Mondor
  • Dijon, France, 21000
    • Centre Hospitalier Universitaire De Dijon
  • Grenoble, France, 38000
    • Centre Hospitalier Universitaire de Grenoble
  • Lille, France, 59037
    • Centre Hospitalier Regional et Universitaire de Lille
  • Lyon, France, 69365
    • Centre Hospitalier St Joseph St Luc
  • Nice, France, 06002
    • Centre Hospitalier Universitaire de Nice
  • Paris, France, 75010
    • Hôpital Bichat
  • Pessac, France, 33604
    • Centre Hospitalier Universitaire De Bordeaux
  • Toulouse, France, 31403
    • Centre Hospitalier Universitaire De Toulouse
• Germany
  • Angermünde, Germany, 16278
    • GLG Fachklinik Wolletzsee GmbH
  • Berlin, Germany, 14050
    • DRK Klinik Berlin Westend
  • Berlin, Germany, 12157
    • AVK Vivantes Rehabilitation GmbH
  • Berlin, Germany, 12559
    • DRK- Kliniken Berlin/ Köpenick
  • Berlin, Germany, 13187
    • Maria Heimsuchung Caritas-Klinik Pankow
  • Berlin, Germany, 13347
    • Jüdisches Krankenhaus
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin Berlin, Centrum für Schlaganfallforschung (CSB)
  • Berlin, Germany, 13509
    • Vivantes Humboldt Klinikum
  • Berlin, Germany, 13585
    • Vivantes Klinikum Spandu
  • Berlin, Germany, 14089
    • GK Havelhöhe
  • Bitterfeld-Wolfen, Germany, 06749
    • Gesundheitszentrum Bitterfeld /Wolfen GmbH
  • Burg, Germany, 03096
    • Mediclin Reha-Zentrum Spreewald Fachklinik für innere Medizin
  • Coswig, Germany, 06869
    • MediClin Herzzentrum Coswig
  • Berlin
    • Berlin - Tegel, Berlin, Germany, 13507
      • Medical Park Berlin Humboldtmühle
    • Bernau, Berlin, Germany, 16321
      • Immanuel Klinikum Bernau Herzzentrum Brandenburg
    • Waldsiedlung, Berlin, Germany, 16321
      • Brandenburgklinik Berlin-Brandenburg GmbH, Haus Brandenburg/ Kardiologie
  • Brandenburg
    • Rüdersdorf, Brandenburg, Germany, 15562
      • Klinik am See, Rehabilitationszentrum für innere Medizin
• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis Egyetem Varosmajori Sziv- es Ergyogyaszati Klinika
  • Budapest, Hungary, 1125
    • Fővárosi Szent János Kórház
  • Budapest, Hungary, H-1085
    • Szent Rókus Kórház és Intézményei
  • Gyula, Hungary, 5700
    • Békés Megyei Pándy Kálmán Kórház
  • Kecskemét, Hungary, 6000
    • Bács- Kiskun Megyei Kórház
  • Székesfehérvár, Hungary, 8000
    • Fejér Megyei Szent György Egyetemi Kórház
  • Veszprém, Hungary, H-8200
    • Sydó és Tsa Kft.
• Italy
  • BA
    • Cassano Delle Murge, BA, Italy, 70020
      • IRCCS Fondazione S. Maugeri Istit. di Cassano Murge
  • BG
    • Osio Sotto, BG, Italy, 24040
      • IOB-Policlinico San Marco
    • Seriate, BG, Italy, 24068
      • Ospedale Bolognini di Seriate - ASST BERGAMO EST
    • Treviglio, BG, Italy, 24047
      • ASST di Bergamo Ovest-Ospedale di Treviglio
  • BS
    • Brescia, BS, Italy, 25123
      • Asst Degli Spedali Civili Di Brescia
  • CN
    • Alba, CN, Italy, 12051
      • Ospedale S.Lazzaro
  • CO
    • Como, CO, Italy, 22100
      • Ospedale Generale di Zona-Ospedale Valduce
  • FG
    • San Severo, FG, Italy, 71016
      • ASL FG Ospedale "Teresa Masselli Mascia"
  • GR
    • Grosseto, GR, Italy, 58100
      • Ospedale Misericordia ASL 9 Grosseto
  • LE
    • Gallipoli, LE, Italy, 73014
      • Ospedale Sacro Cuore di Gesù
  • MB
    • Desio, MB, Italy, 20832
      • ASST Di Monza-Presidio Ospedaliero di Desio
    • Monza, MB, Italy, 20900
      • ASST di Monza-Ospedale San Gerardo
  • MI
    • Milano, MI, Italy, 20122
      • IRCCS Ospedale Policlinico di Milano
    • Milano, MI, Italy, 20138
      • Centro Cardiologico Monzino SpA
    • Milano, MI, Italy, 20142
      • ASST Santi Paolo e Carlo-Ospedale San Paolo-Polo Univ.
    • Milano, MI, Italy, 20149
      • IRCCS-Fondazione Don Carlo Gnocchi
    • Rozzano, MI, Italy, 20089
      • IRCCS Istituto Clinico Humanitas
    • San Donato Milanese, MI, Italy, 20097
      • IRCCS Policlinico San Donato
  • MO
    • Sassuolo, MO, Italy, 41049
      • Ospedale di Sassuolo S.p.A.
  • Passirana-rho
    • Passirana, Passirana-rho, Italy, 20017
      • ASST Rhodense Ospedale di Passirana
  • RM
    • Roma, RM, Italy, 00135
      • Presidio Ospedaliero San Filippo Neri-ASL Roma E
  • RO
    • Roma, RO, Italy, 00149
      • A.O. San Camillo Forlanini
  • SA
    • Salerno, SA, Italy, 84131
      • Ospedale Ss Giovanni di Dio e Ruggi d'Aragona
  • TN
    • Trento, TN, Italy, 38122
      • Casa di Cura Villa Bianca
  • UD
    • San Daniele Del Friuli, UD, Italy, 33038
      • AAS3 "Alto Friuli, Collinare, Medio Friuli" Ospedale di San Daniele del Friuli-Tolmezzo sede di S. D. del Friuli
  • VA
    • Saronno, VA, Italy, 21047
      • ASST Della Valle Olona-Ospedale di Saronno
• Poland
  • Gdańsk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczn
  • Inowrocław, Poland, 88-100
    • Szpital Wielospecjalistyczny im. Dr. Ludwika Błażka w Inowrocławiu
  • Kraków, Poland, 31-202
    • Krakowski Szpital Specjalistyczny im. Jana Pawła II
  • Kłodzko, Poland, 57-300
    • Zespół Opieki Zdrowotnej w Kłodzku
  • Legnica, Poland, 59-220
    • Wojewodzki Szpital Specjalistyczny W Legnicy
  • Wałbrzych, Poland, 58-309
    • Specjalistyczny Szpital im. dra Alfreda Sokołowskiego
  • Wrocław, Poland, 50-315
    • Centrum Kardiologiczne "Pro Corde" Sp. z o.o.
  • Wrocław, Poland, 50-981
    • Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
  • Świdnica, Poland, 58-100
    • Samodzielny Publiczny Zespół Opieki Zdrowotnej w Świdnicy
  • Ochojec
    • Katowice, Ochojec, Poland, 40-635
      • Samodzielny Publiczny Szpital Kliniczny nr 7, Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
• Spain
  • A Coruña, Spain, 15006
    • Hospital Universitario A Coruna
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08036
    • Hospital Clínic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofía de Córdoba
  • Madrid, Spain, 28006
    • Hospital Universitario La Princesa
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Díaz
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de octubre
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos
  • Madrid, Spain, 28003
    • Hospital La Luz Quiron
  • Madrid, Spain, 28006
    • C.H.U. Ruber Juan Bravo
  • Madrid, Spain, 28009
    • Hospital General Universitario Gregorio Marañon
  • Málaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Salamanca, Spain, 37007
    • Complejo Asistencial Universitario de Salamanca
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico de La Fe
  • Valencia, Spain, 46010
    • Hospital Clinic Universitari de Valencia
  • Asturias
    • Gijón, Asturias, Spain, 33203
      • Hospital Universitario de Cabueñes
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08997
      • Hospital Univeristari de Bellvitge
  • Galicia
    • Santiago De Compostela, Galicia, Spain, 15706
      • H.C.U.de Santiago De Compostela
  • Leon
    • León, Leon, Spain, 24008
      • Complejo Asistencial Universitario de León
  • Madrid
    • Alcalá De Henares, Madrid, Spain, 28805
      • Hospital Universitario Príncipe de Asturias
    • Collado-Villalba, Madrid, Spain, 28400
      • Hospital General de Villalba
    • Fuenlabrada, Madrid, Spain, 28492
      • Hospital De Fuenlabrada
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro
    • Móstoles, Madrid, Spain, 28933
      • Hospital Universitario Rey Juan Carlos
    • Pozuelo De Alarcón, Madrid, Spain, 28223
      • Hospital Universitario Quirónsalud Madrid
    • Valdemoro, Madrid, Spain, 28340
      • Hospital Universitario Infanta Elena
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • H.C.U. Virgen De La Arrixaca De Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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..	Drug: Treatment Prevention for Secondary CV; ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.; Other Names: Antiplatelet agents; Lipid Lowering Agents; Renin-angiotensin-aldosterone system blockers
Experimental: 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.	Drug: 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).; Other Names: Polypill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Endpoints	Treatment adherence at 6 months measured using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). Results: Low adherence (0-5); Medium adherence (6-7) and High adherence (8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group.	6 months
Safety Endpoints	All-cause mortality.	Up to 5 Years
Efficacy Endpoints	Treatment adherence at 24 months measured using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). Results: Low adherence (0-5); Medium adherence (6-7) and High adherence (8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group.	2 years
Efficacy Endpoints	The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 1 (6 months). Mean and standard deviation will be reported by treatment group.	6 months
Efficacy Endpoints	The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 2 (12 months). Mean and standard deviation will be reported by treatment group.	12 months
Efficacy Endpoints	The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 3 (24 months). Mean and standard deviation will be reported by treatment group.	2 years
Efficacy Endpoints	The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 1 (6 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.	6 months
Efficacy Endpoints	The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 2 (12 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.	12 months
Efficacy Endpoints	The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 3 (24 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.	2 years
Efficacy Endpoints	Low-density lipoprotein (LDL) cholesterol levels measured in mg/dL at visit 2 (12 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.	12 months
Efficacy Endpoints	Low-density lipoprotein (LDL) cholesterol levels measured in mg/dL at visit 3 (24 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.	2 years
Efficacy Endpoints	The incidence of the first occurrence of any component of the following composite endpoint, as adjudicated by the Clinical Events Committee: Cardiovascular death (CV death); Acute Myocardial Infarction (MI) type 1; stroke. Measured in number of cases.	Up to 5 years
Efficacy Endpoints	The incidence of the first occurrence of the Cardiovascular (CV) death. Measured in number of cases.	Up to 5 years
Efficacy Endpoints	The incidence of the first occurrence of of the Nonfatal type 1 myocardial infarction. Measured in number of cases.	Up to 5 years
Efficacy Endpoints	The incidence of the first occurrence of the Nonfatal ischemic stroke. Measured in number of cases.	Up to 5 years
Efficacy Endpoints	The incidence of the first occurrence of the Urgent coronary revascularization. Measured in number of cases.	Up to 5 years
Efficacy Endpoints	Domain "effectiveness" of the Patient satisfaction measured at visit 1 (6 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 (effectiveness) 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).	6 months
Efficacy Endpoints	Domain "Side effects score" of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM 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 the response was on a Likert-type scale of 5 or 7 points, except for question 4 which a yes/no question about the presence of side effects is asked. If the answer to this question is no (no side effects reported by the participant), other questions will not be asked (questions 5 to 8), and the total score is automatically computed as the maximum of 100. 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.	6 months
Efficacy Endpoints	Domain "Convenience score" of the Patient satisfaction measured at visit 1 (6 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 (Convenience 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).	6 months
Efficacy Endpoints	Domain "Global satisfaction score" of the Patient satisfaction measured at visit 1 (6 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).	6 months
Efficacy Endpoints	Domain "effectiveness" 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 (effectiveness) 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).	24 months
Efficacy Endpoints	Domain "Side effects 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 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 (Side effects score) the response was on a Likert-type scale of 5 or 7 points, except for question 4 which a yes/no question about the presence of side effects is asked. If the answer to this question is no (no side effects reported by the participant), other questions will not be asked (questions 5 to 8), and the total score is automatically computed as the maximum of 100. 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.	24 months
Efficacy Endpoints	Domain "Convenience 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 (Convenience 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).	24 months
Efficacy Endpoints	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).	24 months
Safety Endpoints	The incidence of the first occurrence of the Non-cardiovascular death. Measured in number of cases.	Up to 5 Years

Collaborators and Investigators

• Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
• Collaborators: London School of Hygiene and Tropical Medicine; Ferrer Internacional S.A.; Charite University, Berlin, Germany; Centre Hospitalier Universitaire de Besancon; Wroclaw Medical University; Istituto Di Ricerche Farmacologiche Mario Negri; Semmelweis University; General University Hospital, Prague; Servicio Madrileño de Salud, Madrid, Spain
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• SECURE Clinical Trial Website

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimated): November 4, 2015

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Elderly; Adherence; Cardiovascular Disease; Myocardial Infarction; Randomized Trial; Polypill; Prevention of Secondary Cardiovascular Disease; Cardiovascular Combination Polypill AAR; Cardiovascular Disease in the Elderly; SECURE; Secondary Cardiovascular Disease; Secondary Cardiovascular Prevention; Randomized Cardiovascular Trial; Cardiovascular Polypill
• Additional Relevant MeSH Terms: Vascular Diseases; Pathologic Processes; Neoplasms; Heart Diseases; Necrosis; Neoplastic Processes; Myocardial Ischemia; Ischemia; Cardiovascular Diseases; Neoplasm Metastasis; Myocardial Infarction; Infarction; Platelet Aggregation Inhibitors
• Other Study ID Numbers: 633765; 2015-002868-17 (EudraCT Number)