Secondary Prevention of Cardiovascular Disease in the Elderly Trial

Phase 3

Completed

Interventions: Drug: Treatment Prevention for Secondary CV
Drug: Cardiovascular Polypill

Lead Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Treatment Prevention for Secondary CV	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians..
Cardiovascular Polypill	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day.

Primary Outcome Measures

Name	Time	Method
Major Cardiovascular Adverse Events (MACE)	Up to 5 years	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy Endpoints	24 months	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).
Safety Endpoints	Up to 5 Years	The incidence of the first occurrence of the Non-cardiovascular death. Measured in number of cases.

Locations (113): Fakultní nemocnice Královské Vinohrady
🇨🇿
Praha, Praha 10, Czechia
Nemocnice Na Homolce
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Praha, Praha 5, Czechia
Všeobecná fakultní nemocnice v Praze
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Praha 2, Praha, Czechia
Nemocnice Rudolfa a Stefanie Benešov
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Benešov, Czechia
Nemocnice Jihlava
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Jihlava, Czechia
Krajská necmonice Liberec
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Liberec, Czechia
Fakultní nemocnice Olomouc
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Olomouc, Czechia
Nemocnice Slaný
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Slaný, Czechia
Nemocnice Podlesí
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Třinec, Czechia
Centre Hospitalier Universitaire d'Angers
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Angers, France
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Fakultní nemocnice Královské Vinohrady
🇨🇿Praha, Praha 10, Czechia