Secondary Prevention of Cardiovascular Disease in the Elderly Trial

Myocardial Infarction Clinical Trial

— SECURE  

Official title:

Secondary Prevention of Cardiovascular Disease in the Elderly Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596126
• Other study ID #: 633765
• Secondary ID: 2015-002868-17
• Status: Completed
• Phase: Phase 3
• Start date: July 2016
• Est. completion date: March 31, 2022

Study information

• Verified date: August 2021
• Source: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in elderly patients with a recent myocardial infarction.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2499
• Est. completion date: March 31, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Infarction
• Myocardial Infarction
• Neoplasm Metastasis

Intervention

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).
• Treatment Prevention for Secondary CV
ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.

Locations

Country	Name	City	State
Czechia	Nemocnice Rudolfa a Stefanie Benešov	Benešov
Czechia	Nemocnice Jihlava	Jihlava
Czechia	Krajská necmonice Liberec	Liberec
Czechia	Fakultní nemocnice Olomouc	Olomouc
Czechia	Fakultní nemocnice Královské Vinohrady	Praha	Praha 10
Czechia	Nemocnice Na Homolce	Praha	Praha 5
Czechia	Všeobecná fakultní nemocnice v Praze	Praha 2	Praha
Czechia	Nemocnice Slaný	Slaný
Czechia	Nemocnice Podlesí	Trinec
France	Centre Hospitalier Universitaire d'Angers	Angers
France	Centre Hospitalier Régional Universitaire de Besançon	Besançon
France	Centre Hospitalier Universitaire de Lyon	Bron
France	Centre Hospitalier Universitaire de Caen	Caen
France	Centre Hospitalier Metropole Savoie	Chambéry
France	Centre Hospitalier Universitaire Henri Mondor	Créteil
France	Centre Hospitalier Universitaire de Dijon	Dijon
France	Centre Hospitalier Universitaire de Grenoble	Grenoble
France	Centre Hospitalier Régional et Universitaire de Lille	Lille
France	Centre Hospitalier St Joseph St Luc	Lyon
France	Centre Hospitalier Universitaire de Nice	Nice
France	Hôpital Bichât	Paris
France	Centre hospitalier Universitaire de Bordeaux	Pessac
France	Centre Hospitalier Universitaire de Toulouse	Toulouse
Germany	GLG Fachklinik Wolletzsee GmbH	Angermünde
Germany	AVK Vivantes Rehabilitation GmbH	Berlin
Germany	Charité - Universitätsmedizin Berlin, Centrum für Schlaganfallforschung (CSB)	Berlin
Germany	DRK Klinik Berlin Westend	Berlin
Germany	DRK- Kliniken Berlin/ Köpenick	Berlin
Germany	GK Havelhöhe	Berlin
Germany	Jüdisches Krankenhaus	Berlin
Germany	Maria Heimsuchung Caritas-Klinik Pankow	Berlin
Germany	Vivantes Humboldt Klinikum	Berlin
Germany	Vivantes Klinikum Spandu	Berlin
Germany	Medical Park Berlin Humboldtmühle	Berlin - Tegel	Berlin
Germany	Immanuel Klinikum Bernau Herzzentrum Brandenburg	Bernau	Berlin
Germany	Gesundheitszentrum Bitterfeld /Wolfen GmbH	Bitterfeld-Wolfen
Germany	Mediclin Reha-Zentrum Spreewald Fachklinik für innere Medizin	Burg
Germany	MediClin Herzzentrum Coswig	Coswig
Germany	Klinik am See, Rehabilitationszentrum für innere Medizin	Rüdersdorf	Brandenburg
Germany	Brandenburgklinik Berlin-Brandenburg GmbH, Haus Brandenburg/ Kardiologie	Waldsiedlung	Berlin
Hungary	Fovárosi Szent János Kórház	Budapest
Hungary	Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika	Budapest
Hungary	Szent Rókus Kórház és Intézményei	Budapest
Hungary	Békés Megyei Pándy Kálmán Kórház	Gyula
Hungary	Bács- Kiskun Megyei Kórház	Kecskemét
Hungary	Fejér Megyei Szent György Egyetemi Kórház	Székesfehérvár
Hungary	Sydó és Tsa Kft.	Veszprém
Italy	Ospedale S.Lazzaro	Alba	CN
Italy	ASST Degli Spedali Civili di Brescia	Brescia	BS
Italy	IRCCS Fondazione S. Maugeri Istit. di Cassano Murge	Cassano Delle Murge	BA
Italy	Ospedale Generale di Zona-Ospedale Valduce	Como	CO
Italy	ASST Di Monza-Presidio Ospedaliero di Desio	Desio	MB
Italy	Ospedale Sacro Cuore di Gesù	Gallipoli	LE
Italy	Ospedale Misericordia ASL 9 Grosseto	Grosseto	GR
Italy	ASST Santi Paolo e Carlo-Ospedale San Paolo-Polo Univ.	Milano	MI
Italy	Centro Cardiologico Monzino SpA	Milano	MI
Italy	IRCCS Ospedale Policlinico di Milano	Milano	MI
Italy	IRCCS-Fondazione Don Carlo Gnocchi	Milano	MI
Italy	ASST Di Monza-Ospedale San Gerardo	Monza	MB
Italy	IOB-Policlinico San Marco	Osio Sotto	BG
Italy	ASST Rhodense Ospedale di Passirana	Passirana	Passirana-rho
Italy	A.O. San Camillo Forlanini	Roma	RO
Italy	Presidio Ospedaliero San Filippo Neri-ASL Roma E	Roma	RM
Italy	IRCCS Istituto Clinico Humanitas	Rozzano	MI
Italy	Ospedale Ss Giovanni di Dio e Ruggi d'Aragona	Salerno	SA
Italy	AAS3 "Alto Friuli, Collinare, Medio Friuli" Ospedale di San Daniele del Friuli-Tolmezzo sede di S. D. del Friuli	San Daniele Del Friuli	UD
Italy	IRCCS Policlinico San Donato	San Donato Milanese	MI
Italy	ASL FG Ospedale "Teresa Masselli Mascia"	San Severo	FG
Italy	ASST Della Valle Olona-Ospedale di Saronno	Saronno	VA
Italy	Ospedale di Sassuolo S.P.A.	Sassuolo	MO
Italy	Ospedale Bolognini di Seriate - ASST BERGAMO EST	Seriate	BG
Italy	Casa di Cura Villa Bianca	Trento	TN
Italy	ASST di Bergamo Ovest-Ospedale di Treviglio	Treviglio	BG
Poland	Uniwersyteckie Centrum Kliniczn	Gdansk
Poland	Szpital Wielospecjalistyczny im. Dr. Ludwika Blazka w Inowroclawiu	Inowroclaw
Poland	Samodzielny Publiczny Szpital Kliniczny nr 7, Slaskiego Uniwersytetu Medycznego w Katowicach, Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca	Katowice	Ochojec
Poland	Zespól Opieki Zdrowotnej w Klodzku	Klodzko
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II	Kraków
Poland	Wojewódzki Szpital Specjalistyczny w Legnicy	Legnica
Poland	Samodzielny Publiczny Zespól Opieki Zdrowotnej w Swidnicy	Swidnica
Poland	Specjalistyczny Szpital im. Dra Alfreda Sokolowskiego	Walbrzych
Poland	Centrum Kardiologiczne "Pro Corde" Sp. z o.o.	Wroclaw
Poland	Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ	Wroclaw
Spain	Hospital Universitario A Coruña	A Coruña
Spain	Hospital Universitario Principe de Asturias	Alcalá De Henares	Madrid
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitari Vall D'hebron	Barcelona
Spain	Hospital General de Villalba	Collado-Villalba	Madrid
Spain	Hospital Universitario Reina Sofia de Cordoba	Córdoba
Spain	H.C.U. Virgen De La Arrixaca De Murcia	El Palmar	Murcia
Spain	Hospital de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitario de Cabueñes	Gijón	Asturias
Spain	Hospital Univeristari de Bellvitge	L'Hospitalet De Llobregat	Barcelona
Spain	Complejo Asistencial Universitario de Leon	León	Leon
Spain	C.H.U. Ruber Juan Bravo	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital La Luz Quiron	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Clinico San Carlos	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital Universitario Rey Juan Carlos	Móstoles	Madrid
Spain	Hospital Universitario QuironSalud Madrid	Pozuelo De Alarcón	Madrid
Spain	Complejo Asistencial Universitario de Salamanca	Salamanca
Spain	H.C.U.de Santiago De Compostela	Santiago De Compostela	Galicia
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario Infanta Elena	Valdemoro	Madrid
Spain	Hospital Clinic Universitari de Valencia	Valencia
Spain	Hospital Universitario y Politécnico de La Fe	Valencia

Sponsors (10)

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

Countries where clinical trial is conducted

Czechia,  France,  Germany,  Hungary,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 months
Secondary	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	Baseline
Secondary	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	6 months after treatment initiation
Secondary	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	12 months after treatment initiation
Secondary	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.	18 months after treatment initiation
Secondary	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.	24 months after treatment initiation
Secondary	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.	36 months after treatment initiation
Secondary	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.	48 months after treatment initiation
Secondary	Change in Treatment Adherence	The Morisky-Medication Adherence Scale (8 item) Questionnaire will be administered	6 months after patient treatment
Secondary	Change in Treatment Adherence	The Morisky-Medication Adherence Scale (8 item) Questionnaire will be administered	24 months after patient treatment
Secondary	Change in Patient Satisfaction	The treatment Satisfaction Questionnaire for Medication (TSQM) will be administered	6 months after patient treatment
Secondary	Change in Patient Satisfaction	The treatment Satisfaction Questionnaire for Medication (TSQM) will be administered	24 months after patient treatment
Secondary	Change in Systolic and Diastolic Blood Pressure (SBP and DBP)	Systolic and diastolic blood pressure will be collected and summarized at each timepoint.	Baseline
Secondary	Change in Systolic and Diastolic Blood Pressure (SBP and DBP)	Systolic and diastolic blood pressure will be collected and summarized at each timepoint.	6 months after patient treatment
Secondary	Change in Systolic and Diastolic Blood Pressure (SBP and DBP)	Systolic and diastolic blood pressure will be collected and summarized at each timepoint.	12 months after patient treatment
Secondary	Change in Systolic and Diastolic Blood Pressure (SBP and DBP)	Systolic and diastolic blood pressure will be collected and summarized at each timepoint.	24 months after patient treatment
Secondary	Change in LDL cholesterol level	Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.	Baseline
Secondary	Change in LDL cholesterol level	Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.	12 months after patient treatment
Secondary	Change in LDL cholesterol level	Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.	24 months after patient treatment
Secondary	Regional differences in performance of the polypill in the previous endpoints	Assessed	6 months after patient treatment
Secondary	Regional differences in performance of the polypill in the previous endpoints	Assessed	12 months after patient treatment
Secondary	Regional differences in performance of the polypill in the previous endpoints	Assessed	24 months after patient treatment
Secondary	Health Economic Evaluation Comparing Intervention and Usual Care Arm	Cost differences and Incremental Cost-Effectiveness Ratio (ICER) will be assessed at each timepoint.	6 months after patient treatment
Secondary	Health Economic Evaluation Comparing Intervention and Usual Care Arm	Cost differences and Incremental Cost-Effectiveness Ratio (ICER) will be assessed at each timepoint.	12 months after patient treatment
Secondary	Health Economic Evaluation Comparing Intervention and Usual Care Arm	Cost differences and Incremental Cost-Effectiveness Ratio (ICER) will be assessed at each timepoint.	24 months after patient treatment
Secondary	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.	Baseline
Secondary	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.	24 months after patient treatment
Secondary	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).	Baseline
Secondary	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).	6 months after patient treatment
Secondary	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).	12 months after patient treatment
Secondary	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).	18 months after patient treatment
Secondary	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).	24 months after patient treatment
Secondary	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).	36 months after patient treatment
Secondary	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).	48 months after patient treatment

External Links

•   SECURE Clinical Trial Website