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AzTrials

Myocardial InfarctionPhase 3SECURENCT02596126

Secondary Prevention of Cardiovascular Disease in the Elderly Trial

A Phase 3 study testing Cardiovascular Polypill and Treatment Prevention for Secondary CV in people with Myocardial Infarction and Cardiovascular Disease, run by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III at 113 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Myocardial Infarction, Cardiovascular Disease
What is being tested?
Cardiovascular Polypill and Treatment Prevention for Secondary CV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,499 participants
Where
113 sitesin 7 countries
Study dates
Jul 2016to 31 Mar 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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).
Show all 9Show fewer
  • 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.

Who cannot join

  • 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).
Show all 12Show fewer
  • 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.

Trial locations and contacts

113 sites in 7 countries.

113 sites in 7 countries

Spain30 sites

  • Hospital Universitario A Coruña

    A Coruña, 15006

  • Hospital Universitario Principe de Asturias

    Alcalá de Henares, Madrid, 28805

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitari Vall D'hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital General de Villalba

    Collado Villalba, Madrid, 28400

  • Hospital Universitario Reina Sofia de Cordoba

    Córdoba, 14004

  • H.C.U. Virgen De La Arrixaca De Murcia

    El Palmar, Murcia, 30120

  • Hospital de Fuenlabrada

    Fuenlabrada, Madrid, 28492

  • Hospital Universitario de Cabueñes

    Gijón, Principality of Asturias, 33203

  • Hospital Univeristari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08997

  • Complejo Asistencial Universitario de Leon

    León, Leon, 24008

  • Hospital La Luz Quiron

    Madrid, 28003

  • C.H.U. Ruber Juan Bravo

    Madrid, 28006

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28009

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Rey Juan Carlos

    Móstoles, Madrid, 28933

  • Hospital Universitario QuironSalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007

  • H.C.U.de Santiago De Compostela

    Santiago de Compostela, Galicia, 15706

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Infanta Elena

    Valdemoro, Madrid, 28340

  • Hospital Clinic Universitari de Valencia

    Valencia, 46010

  • Hospital Universitario y Politécnico de La Fe

    Valencia, 46026

Other trials in Spain

Italy26 sites

  • Ospedale S.Lazzaro

    Alba, CN, 12051

  • ASST Degli Spedali Civili di Brescia

    Brescia, BS, 25123

  • IRCCS Fondazione S. Maugeri Istit. di Cassano Murge

    Cassano delle Murge, BA, 70020

  • Ospedale Generale di Zona-Ospedale Valduce

    Como, CO, 22100

  • ASST Di Monza-Presidio Ospedaliero di Desio

    Desio, MB, 20832

  • Ospedale Sacro Cuore di Gesù

    Gallipoli, LE, 73014

  • Ospedale Misericordia ASL 9 Grosseto

    Grosseto, GR, 58100

  • IRCCS Ospedale Policlinico di Milano

    Milan, MI, 20122

  • Centro Cardiologico Monzino SpA

    Milan, MI, 20138

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

    Milan, MI, 20142

  • IRCCS-Fondazione Don Carlo Gnocchi

    Milan, MI, 20149

  • ASST Di Monza-Ospedale San Gerardo

    Monza, MB, 20900

  • IOB-Policlinico San Marco

    Osio Sotto, BG, 24040

  • ASST Rhodense Ospedale di Passirana

    Passirana, Passirana-rho, 20017

  • Presidio Ospedaliero San Filippo Neri-ASL Roma E

    Roma, RM, 00135

  • A.O. San Camillo Forlanini

    Roma, RO, 00149

  • IRCCS Istituto Clinico Humanitas

    Rozzano, MI, 20089

  • Ospedale Ss Giovanni di Dio e Ruggi d'Aragona

    Salerno, SA, 84131

  • 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

  • IRCCS Policlinico San Donato

    San Donato Milanese, MI, 20097

  • ASL FG Ospedale "Teresa Masselli Mascia"

    San Severo, FG, 71016

  • ASST Della Valle Olona-Ospedale di Saronno

    Saronno, VA, 21047

  • Ospedale di Sassuolo S.P.A.

    Sassuolo, MO, 41049

  • Ospedale Bolognini di Seriate - ASST BERGAMO EST

    Seriate, BG, 24068

  • Casa di Cura Villa Bianca

    Trento, TN, 38122

  • ASST di Bergamo Ovest-Ospedale di Treviglio

    Treviglio, BG, 24047

Other trials in Italy

Germany17 sites

  • GLG Fachklinik Wolletzsee GmbH

    Angermünde, 16278

  • AVK Vivantes Rehabilitation GmbH

    Berlin, 12157

  • DRK- Kliniken Berlin/ Köpenick

    Berlin, 12559

  • Maria Heimsuchung Caritas-Klinik Pankow

    Berlin, 13187

  • Jüdisches Krankenhaus

    Berlin, 13347

  • Charité - Universitätsmedizin Berlin, Centrum für Schlaganfallforschung (CSB)

    Berlin, 13353

  • Vivantes Humboldt Klinikum

    Berlin, 13509

  • Vivantes Klinikum Spandu

    Berlin, 13585

  • DRK Klinik Berlin Westend

    Berlin, 14050

  • GK Havelhöhe

    Berlin, 14089

  • Immanuel Klinikum Bernau Herzzentrum Brandenburg

    Bernau, State of Berlin, 16321

  • Gesundheitszentrum Bitterfeld /Wolfen GmbH

    Bitterfeld-Wolfen, 06749

  • Mediclin Reha-Zentrum Spreewald Fachklinik für innere Medizin

    Burg, 03096

  • MediClin Herzzentrum Coswig

    Coswig, 06869

  • Klinik am See, Rehabilitationszentrum für innere Medizin

    Rüdersdorf, Brandenburg, 15562

  • Medical Park Berlin Humboldtmühle

    Tegel, State of Berlin, 13507

  • Brandenburgklinik Berlin-Brandenburg GmbH, Haus Brandenburg/ Kardiologie

    Waldsiedlung, State of Berlin, 16321

Other trials in Germany

France14 sites

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49933

  • Centre Hospitalier Régional Universitaire de Besançon

    Besançon, 25030

  • Centre Hospitalier Universitaire de Lyon

    Bron, 69500

  • Centre Hospitalier Universitaire de Caen

    Caen, 14000

  • Centre Hospitalier Metropole Savoie

    Chambéry, 73000

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94000

  • Centre Hospitalier Universitaire de Dijon

    Dijon, 21000

  • Centre Hospitalier Universitaire de Grenoble

    Grenoble, 38000

  • Centre Hospitalier Régional et Universitaire de Lille

    Lille, 59037

  • Centre Hospitalier St Joseph St Luc

    Lyon, 69365

  • Centre Hospitalier Universitaire de Nice

    Nice, 06002

  • Hôpital Bichât

    Paris, 75010

  • Centre hospitalier Universitaire de Bordeaux

    Pessac, 33604

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, 31403

Other trials in France

Poland10 sites

  • Uniwersyteckie Centrum Kliniczn

    Gdansk, 80-952

  • Szpital Wielospecjalistyczny im. Dr. Ludwika Błażka w Inowrocławiu

    Inowrocław, 88-100

  • Samodzielny Publiczny Szpital Kliniczny nr 7, Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca

    Katowice, Ochojec, 40-635

  • Zespół Opieki Zdrowotnej w Kłodzku

    Kłodzko, 57-300

  • Krakowski Szpital Specjalistyczny im. Jana Pawła II

    Krakow, 31-202

  • Wojewódzki Szpital Specjalistyczny w Legnicy

    Legnica, 59-220

  • Samodzielny Publiczny Zespół Opieki Zdrowotnej w Świdnicy

    Swidnica, 58-100

  • Specjalistyczny Szpital im. Dra Alfreda Sokołowskiego

    Wałbrzych, 58-309

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

    Wroclaw, 50-315

  • Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ

    Wroclaw, 50-981

Other trials in Poland

Czechia9 sites

  • Nemocnice Rudolfa a Stefanie Benešov

    Benešov, 25601

  • Nemocnice Jihlava

    Jihlava, 58633

  • Krajská necmonice Liberec

    Liberec, 46030

  • Fakultní nemocnice Olomouc

    Olomouc, 77900

  • Všeobecná fakultní nemocnice v Praze

    Prague, Prague, 12808

  • Fakultní nemocnice Královské Vinohrady

    Prague, Praha 10, 10034

  • Nemocnice Na Homolce

    Prague, Praha 5, 15030

  • Nemocnice Slaný

    Slaný, 27401

  • Nemocnice Podlesí

    Třinec, 73961

Other trials in Czechia

Hungary7 sites

  • Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika

    Budapest, 1122

  • Fővárosi Szent János Kórház

    Budapest, 1125

  • Szent Rókus Kórház és Intézményei

    Budapest, H-1085

  • Békés Megyei Pándy Kálmán Kórház

    Gyula, 5700

  • Bács- Kiskun Megyei Kórház

    Kecskemét, 6000

  • Fejér Megyei Szent György Egyetemi Kórház

    Székesfehérvár, 8000

  • Sydó és Tsa Kft.

    Veszprém, H-8200

Other trials in Hungary

About this study

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.

Read the 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

Being tested
Cardiovascular Polypill, Treatment Prevention for Secondary CV
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
Medical subject headings
Myocardial Infarction, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiovascular PolypillDrug

    Also called 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).

  • Treatment Prevention for Secondary CVDrug

    Also called Antiplatelet agents, Lipid Lowering Agents, Renin-angiotensin-aldosterone system blockers

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

Study groups in NCT02596126
Study groupRoleWhat they receive
Treatment Prevention for Secondary CVActive 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..
Receives: Drug: Treatment Prevention for Secondary CV
Cardiovascular PolypillExperimentalPatients 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.
Receives: Drug: Cardiovascular Polypill

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 5 years

Secondary outcomes (25)

  1. 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.

    Measured: 6 months

  2. Safety Endpoints

    All-cause mortality.

    Measured: Up to 5 Years

  3. 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.

    Measured: 2 years

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: 12 months

  6. 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.

    Measured: 2 years

  7. 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.

    Measured: 6 months

  8. 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.

    Measured: 12 months

  9. 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.

    Measured: 2 years

  10. 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.

    Measured: 12 months

  11. 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.

    Measured: 2 years

  12. 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.

    Measured: Up to 5 years

  13. Efficacy Endpoints

    The incidence of the first occurrence of the Cardiovascular (CV) death. Measured in number of cases.

    Measured: Up to 5 years

  14. Efficacy Endpoints

    The incidence of the first occurrence of of the Nonfatal type 1 myocardial infarction. Measured in number of cases.

    Measured: Up to 5 years

  15. Efficacy Endpoints

    The incidence of the first occurrence of the Nonfatal ischemic stroke. Measured in number of cases.

    Measured: Up to 5 years

  16. Efficacy Endpoints

    The incidence of the first occurrence of the Urgent coronary revascularization. Measured in number of cases.

    Measured: Up to 5 years

  17. 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).

    Measured: 6 months

  18. 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.

    Measured: 6 months

  19. 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).

    Measured: 6 months

  20. 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).

    Measured: 6 months

  21. 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).

    Measured: 24 months

  22. 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.

    Measured: 24 months

  23. 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).

    Measured: 24 months

  24. 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).

    Measured: 24 months

  25. Safety Endpoints

    The incidence of the first occurrence of the Non-cardiovascular death. Measured in number of cases.

    Measured: Up to 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2015 (estimated)
  2. Study startJul 2016
  3. Primary completion31 Oct 2021
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,499 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02596126
Sponsor's protocol ID
633765
Other IDs
2015-002868-17, 2015
Acronym
SECURE
Status last verified
Aug 2021
First submitted
5 Oct 2015
Last updated
23 May 2025
Data monitoring committee
Yes

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.

    PubMed 36018037

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cardiovascular Polypill and Treatment Prevention for Secondary CV in people with Myocardial Infarction and Cardiovascular Disease, run by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III at 113 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in Spain, Italy, Germany, France, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Cardiovascular Adverse Events (MACE) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02596126, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

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