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Phase 3 N=2,499 Randomized Prevention

Secondary Prevention of Cardiovascular Disease in the Elderly Trial

Myocardial Infarction · Cardiovascular Disease

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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