Secondary Prevention of Cardiovascular Disease in the Elderly Trial

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 followingadditional conditions:

• Documented diabetes mellitus or previous treatment with oral hypoglycemic drugsor 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 eventdocumented in a medical report.

• Prior coronary revascularization: coronary artery bypass grafting (CABG) orpercutaneous coronary intervention (PCI).

• Prior stroke: history of a documented stroke, defined as an acute episode offocal cerebral, spinal, or retinal dysfunction caused by infarction of centralnervous 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 futuremonths.

9. Any condition limiting life expectancy <2 years, including but not limited to activemalignancy.

10. Significant arrhythmias (including unresolved ventricular arrhythmias or atrialfibrillation).

11. Scheduled coronary revascularization (patients can be randomized after finalrevascularization is completed within the prespecified timeframe).

12. Do not agree to the filing, forwarding and use of his/ her pseudonymised data.