Phase 3
N=2,499
Secondary Prevention of Cardiovascular Disease in the Elderly Trial
Myocardial Infarction · Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT02596126 ↗Enrolled (actual)
2,499
Serious AEs
19.0%
Results posted
May 2025
Primary outcome: Primary: Major Cardiovascular Adverse Events (MACE) — 156; 118 number of adjudicated events — p=< 0.025
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cardiovascular Polypill (Drug); Treatment Prevention for Secondary CV (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Cardiovascular Adverse Events (MACE) |
156; 118 | < 0.025 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Safety Endpoints |
46; 67 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Efficacy Endpoints |
67.76; 74.36 | < 0.05 sig |
| SECONDARY Safety Endpoints |
46; 67 | < 0.05 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02596126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.