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

Primary Purpose

Myocardial Infarction, Cardiovascular Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cardiovascular Polypill
Treatment Prevention for Secondary CV
Sponsored by
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction focused on measuring 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

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fakultní nemocnice Královské Vinohrady
  • Nemocnice Na Homolce
  • Všeobecná fakultní nemocnice v Praze
  • Nemocnice Rudolfa a Stefanie Benešov
  • Nemocnice Jihlava
  • Krajská necmonice Liberec
  • Fakultní nemocnice Olomouc
  • Nemocnice Slaný
  • Nemocnice Podlesí
  • Centre Hospitalier Universitaire d'Angers
  • Centre Hospitalier Régional Universitaire de Besançon
  • Centre Hospitalier Universitaire de Lyon
  • Centre Hospitalier Universitaire de Caen
  • Centre Hospitalier Metropole Savoie
  • Centre Hospitalier Universitaire Henri Mondor
  • Centre Hospitalier Universitaire de Dijon
  • Centre Hospitalier Universitaire de Grenoble
  • Centre Hospitalier Régional et Universitaire de Lille
  • Centre Hospitalier St Joseph St Luc
  • Centre Hospitalier Universitaire de Nice
  • Hôpital Bichât
  • Centre hospitalier Universitaire de Bordeaux
  • Centre Hospitalier Universitaire de Toulouse
  • Medical Park Berlin Humboldtmühle
  • Immanuel Klinikum Bernau Herzzentrum Brandenburg
  • Brandenburgklinik Berlin-Brandenburg GmbH, Haus Brandenburg/ Kardiologie
  • Klinik am See, Rehabilitationszentrum für innere Medizin
  • GLG Fachklinik Wolletzsee GmbH
  • AVK Vivantes Rehabilitation GmbH
  • DRK- Kliniken Berlin/ Köpenick
  • Maria Heimsuchung Caritas-Klinik Pankow
  • Jüdisches Krankenhaus
  • Charité - Universitätsmedizin Berlin, Centrum für Schlaganfallforschung (CSB)
  • Vivantes Humboldt Klinikum
  • Vivantes Klinikum Spandu
  • DRK Klinik Berlin Westend
  • GK Havelhöhe
  • Gesundheitszentrum Bitterfeld /Wolfen GmbH
  • Mediclin Reha-Zentrum Spreewald Fachklinik für innere Medizin
  • MediClin Herzzentrum Coswig
  • Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
  • Fővárosi Szent János Kórház
  • Szent Rókus Kórház és Intézményei
  • Békés Megyei Pándy Kálmán Kórház
  • Bács- Kiskun Megyei Kórház
  • Fejér Megyei Szent György Egyetemi Kórház
  • Sydó és Tsa Kft.
  • IRCCS Fondazione S. Maugeri Istit. di Cassano Murge
  • IOB-Policlinico San Marco
  • Ospedale Bolognini di Seriate - ASST BERGAMO EST
  • ASST di Bergamo Ovest-Ospedale di Treviglio
  • ASST Degli Spedali Civili di Brescia
  • Ospedale S.Lazzaro
  • Ospedale Generale di Zona-Ospedale Valduce
  • ASL FG Ospedale "Teresa Masselli Mascia"
  • Ospedale Misericordia ASL 9 Grosseto
  • Ospedale Sacro Cuore di Gesù
  • ASST Di Monza-Presidio Ospedaliero di Desio
  • ASST Di Monza-Ospedale San Gerardo
  • IRCCS Ospedale Policlinico di Milano
  • Centro Cardiologico Monzino SpA
  • ASST Santi Paolo e Carlo-Ospedale San Paolo-Polo Univ.
  • IRCCS-Fondazione Don Carlo Gnocchi
  • IRCCS Istituto Clinico Humanitas
  • IRCCS Policlinico San Donato
  • Ospedale di Sassuolo S.P.A.
  • ASST Rhodense Ospedale di Passirana
  • Presidio Ospedaliero San Filippo Neri-ASL Roma E
  • A.O. San Camillo Forlanini
  • Ospedale Ss Giovanni di Dio e Ruggi d'Aragona
  • Casa di Cura Villa Bianca
  • AAS3 "Alto Friuli, Collinare, Medio Friuli" Ospedale di San Daniele del Friuli-Tolmezzo sede di S. D. del Friuli
  • ASST Della Valle Olona-Ospedale di Saronno
  • Samodzielny Publiczny Szpital Kliniczny nr 7, Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
  • Uniwersyteckie Centrum Kliniczn
  • Szpital Wielospecjalistyczny im. Dr. Ludwika Błażka w Inowrocławiu
  • Krakowski Szpital Specjalistyczny im. Jana Pawła II
  • Zespół Opieki Zdrowotnej w Kłodzku
  • Wojewódzki Szpital Specjalistyczny w Legnicy
  • Specjalistyczny Szpital im. Dra Alfreda Sokołowskiego
  • Centrum Kardiologiczne "Pro Corde" Sp. z o.o.
  • Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
  • Samodzielny Publiczny Zespół Opieki Zdrowotnej w Świdnicy
  • Hospital Universitario de Cabueñes
  • Hospital Univeristari de Bellvitge
  • H.C.U.de Santiago De Compostela
  • Complejo Asistencial Universitario de Leon
  • Hospital Universitario Principe de Asturias
  • Hospital General de Villalba
  • Hospital de Fuenlabrada
  • Hospital Universitario Puerta de Hierro
  • Hospital Universitario Rey Juan Carlos
  • Hospital Universitario QuironSalud Madrid
  • Hospital Universitario Infanta Elena
  • H.C.U. Virgen De La Arrixaca De Murcia
  • Hospital Universitario A Coruña
  • Hospital General Universitario de Alicante
  • Hospital Universitari Vall D'hebron
  • Hospital Clinic de Barcelona
  • Hospital Universitario Reina Sofia de Cordoba
  • Hospital La Luz Quiron
  • C.H.U. Ruber Juan Bravo
  • Hospital Universitario La Princesa
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario Clinico San Carlos
  • Hospital Universitario Fundación Jiménez Díaz
  • Hospital Universitario 12 de Octubre
  • Hospital Virgen de la Victoria
  • Complejo Asistencial Universitario de Salamanca
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Virgen del Rocio
  • Hospital Clinic Universitari de Valencia
  • Hospital Universitario y Politécnico de La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment Prevention for Secondary CV

Cardiovascular Polypill

Arm Description

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..

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.

Outcomes

Primary Outcome Measures

Difference in the occurrence of Major Adverse Cardiovascular Events (MACE) between the Cardiovascular Combination Polypill AAR and the Standard of Care Treatment
Cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent revascularization

Secondary Outcome Measures

Incidence of the first occurrence of any component of the following composite endpoint: CV death, MI, stroke.
Cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent revascularization
Incidence of the first occurrence of any component of the following composite endpoint: CV death, MI, stroke.
Cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent revascularization
Incidence of the first occurrence of any component of the following composite endpoint: CV death, MI, stroke.
Cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent revascularization
Evaluate the first occurrence of the individual components of the primary endpoint
CV death. Nonfatal type 1 myocardial infarction. Nonfatal ischemic stroke. Urgent coronary revascularization.
Evaluate the first occurrence of the individual components of the primary endpoint
CV death. Nonfatal type 1 myocardial infarction. Nonfatal ischemic stroke. Urgent coronary revascularization.
Evaluate the first occurrence of the individual components of the primary endpoint
CV death. Nonfatal type 1 myocardial infarction. Nonfatal ischemic stroke. Urgent coronary revascularization.
Evaluate the first occurrence of the individual components of the primary endpoint
CV death. Nonfatal type 1 myocardial infarction. Nonfatal ischemic stroke. Urgent coronary revascularization.
Change in Treatment Adherence
The Morisky-Medication Adherence Scale (8 item) Questionnaire will be administered
Change in Treatment Adherence
The Morisky-Medication Adherence Scale (8 item) Questionnaire will be administered
Change in Patient Satisfaction
The treatment Satisfaction Questionnaire for Medication (TSQM) will be administered
Change in Patient Satisfaction
The treatment Satisfaction Questionnaire for Medication (TSQM) will be administered
Change in Systolic and Diastolic Blood Pressure (SBP and DBP)
Systolic and diastolic blood pressure will be collected and summarized at each timepoint.
Change in Systolic and Diastolic Blood Pressure (SBP and DBP)
Systolic and diastolic blood pressure will be collected and summarized at each timepoint.
Change in Systolic and Diastolic Blood Pressure (SBP and DBP)
Systolic and diastolic blood pressure will be collected and summarized at each timepoint.
Change in Systolic and Diastolic Blood Pressure (SBP and DBP)
Systolic and diastolic blood pressure will be collected and summarized at each timepoint.
Change in LDL cholesterol level
Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.
Change in LDL cholesterol level
Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.
Change in LDL cholesterol level
Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.
Regional differences in performance of the polypill in the previous endpoints
Assessed
Regional differences in performance of the polypill in the previous endpoints
Assessed
Regional differences in performance of the polypill in the previous endpoints
Assessed
Health Economic Evaluation Comparing Intervention and Usual Care Arm
Cost differences and Incremental Cost-Effectiveness Ratio (ICER) will be assessed at each timepoint.
Health Economic Evaluation Comparing Intervention and Usual Care Arm
Cost differences and Incremental Cost-Effectiveness Ratio (ICER) will be assessed at each timepoint.
Health Economic Evaluation Comparing Intervention and Usual Care Arm
Cost differences and Incremental Cost-Effectiveness Ratio (ICER) will be assessed at each timepoint.
Change in Quality of Life
The European Quality of Life- 5 Dimensions (EQ-5D) Questionnaire will be administered at each timepoint to evaluate change in quality of life.
Change in Quality of Life
The European Quality of Life- 5 Dimensions (EQ-5D) Questionnaire will be administered at each timepoint to evaluate change in quality of life.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).

Full Information

First Posted
October 5, 2015
Last Updated
October 5, 2022
Sponsor
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Collaborators
Charite University, Berlin, Germany, Centre Hospitalier Universitaire de Besancon, Wroclaw Medical University, Semmelweis University, General University Hospital, Prague, Servicio Madrileño de Salud, Madrid, Spain, London School of Hygiene and Tropical Medicine, Ferrer Internacional S.A., Istituto Di Ricerche Farmacologiche Mario Negri
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1. Study Identification

Unique Protocol Identification Number
NCT02596126
Brief Title
Secondary Prevention of Cardiovascular Disease in the Elderly Trial
Acronym
SECURE
Official Title
Secondary Prevention of Cardiovascular Disease in the Elderly Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2499 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Prevention for Secondary CV
Arm Type
Active Comparator
Arm Description
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..
Arm Title
Cardiovascular Polypill
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cardiovascular Polypill
Other Intervention Name(s)
Polypill
Intervention Description
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
Intervention Name(s)
Treatment Prevention for Secondary CV
Other Intervention Name(s)
Antiplatelet agents, Lipid Lowering Agents, Renin-angiotensin-aldosterone system blockers
Intervention Description
ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
Primary Outcome Measure Information:
Title
Difference in the occurrence of Major Adverse Cardiovascular Events (MACE) between the Cardiovascular Combination Polypill AAR and the Standard of Care Treatment
Description
Cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent revascularization
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Incidence of the first occurrence of any component of the following composite endpoint: CV death, MI, stroke.
Description
Cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent revascularization
Time Frame
Baseline
Title
Incidence of the first occurrence of any component of the following composite endpoint: CV death, MI, stroke.
Description
Cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent revascularization
Time Frame
6 months after treatment initiation
Title
Incidence of the first occurrence of any component of the following composite endpoint: CV death, MI, stroke.
Description
Cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent revascularization
Time Frame
12 months after treatment initiation
Title
Evaluate the first occurrence of the individual components of the primary endpoint
Description
CV death. Nonfatal type 1 myocardial infarction. Nonfatal ischemic stroke. Urgent coronary revascularization.
Time Frame
18 months after treatment initiation
Title
Evaluate the first occurrence of the individual components of the primary endpoint
Description
CV death. Nonfatal type 1 myocardial infarction. Nonfatal ischemic stroke. Urgent coronary revascularization.
Time Frame
24 months after treatment initiation
Title
Evaluate the first occurrence of the individual components of the primary endpoint
Description
CV death. Nonfatal type 1 myocardial infarction. Nonfatal ischemic stroke. Urgent coronary revascularization.
Time Frame
36 months after treatment initiation
Title
Evaluate the first occurrence of the individual components of the primary endpoint
Description
CV death. Nonfatal type 1 myocardial infarction. Nonfatal ischemic stroke. Urgent coronary revascularization.
Time Frame
48 months after treatment initiation
Title
Change in Treatment Adherence
Description
The Morisky-Medication Adherence Scale (8 item) Questionnaire will be administered
Time Frame
6 months after patient treatment
Title
Change in Treatment Adherence
Description
The Morisky-Medication Adherence Scale (8 item) Questionnaire will be administered
Time Frame
24 months after patient treatment
Title
Change in Patient Satisfaction
Description
The treatment Satisfaction Questionnaire for Medication (TSQM) will be administered
Time Frame
6 months after patient treatment
Title
Change in Patient Satisfaction
Description
The treatment Satisfaction Questionnaire for Medication (TSQM) will be administered
Time Frame
24 months after patient treatment
Title
Change in Systolic and Diastolic Blood Pressure (SBP and DBP)
Description
Systolic and diastolic blood pressure will be collected and summarized at each timepoint.
Time Frame
Baseline
Title
Change in Systolic and Diastolic Blood Pressure (SBP and DBP)
Description
Systolic and diastolic blood pressure will be collected and summarized at each timepoint.
Time Frame
6 months after patient treatment
Title
Change in Systolic and Diastolic Blood Pressure (SBP and DBP)
Description
Systolic and diastolic blood pressure will be collected and summarized at each timepoint.
Time Frame
12 months after patient treatment
Title
Change in Systolic and Diastolic Blood Pressure (SBP and DBP)
Description
Systolic and diastolic blood pressure will be collected and summarized at each timepoint.
Time Frame
24 months after patient treatment
Title
Change in LDL cholesterol level
Description
Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.
Time Frame
Baseline
Title
Change in LDL cholesterol level
Description
Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.
Time Frame
12 months after patient treatment
Title
Change in LDL cholesterol level
Description
Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.
Time Frame
24 months after patient treatment
Title
Regional differences in performance of the polypill in the previous endpoints
Description
Assessed
Time Frame
6 months after patient treatment
Title
Regional differences in performance of the polypill in the previous endpoints
Description
Assessed
Time Frame
12 months after patient treatment
Title
Regional differences in performance of the polypill in the previous endpoints
Description
Assessed
Time Frame
24 months after patient treatment
Title
Health Economic Evaluation Comparing Intervention and Usual Care Arm
Description
Cost differences and Incremental Cost-Effectiveness Ratio (ICER) will be assessed at each timepoint.
Time Frame
6 months after patient treatment
Title
Health Economic Evaluation Comparing Intervention and Usual Care Arm
Description
Cost differences and Incremental Cost-Effectiveness Ratio (ICER) will be assessed at each timepoint.
Time Frame
12 months after patient treatment
Title
Health Economic Evaluation Comparing Intervention and Usual Care Arm
Description
Cost differences and Incremental Cost-Effectiveness Ratio (ICER) will be assessed at each timepoint.
Time Frame
24 months after patient treatment
Title
Change in Quality of Life
Description
The European Quality of Life- 5 Dimensions (EQ-5D) Questionnaire will be administered at each timepoint to evaluate change in quality of life.
Time Frame
Baseline
Title
Change in Quality of Life
Description
The European Quality of Life- 5 Dimensions (EQ-5D) Questionnaire will be administered at each timepoint to evaluate change in quality of life.
Time Frame
24 months after patient treatment
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Time Frame
Baseline
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Time Frame
6 months after patient treatment
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Time Frame
12 months after patient treatment
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Time Frame
18 months after patient treatment
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Time Frame
24 months after patient treatment
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Time Frame
36 months after patient treatment
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Time Frame
48 months after patient treatment

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
36018037
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.
Results Reference
derived
PubMed Identifier
34324628
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.
Results Reference
derived
Links:
URL
http://secure-h2020.eu/
Description
SECURE Clinical Trial Website

Learn more about this trial

Secondary Prevention of Cardiovascular Disease in the Elderly Trial

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