CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,499 enrolled
Drug / intervention
Cardiovascular Polypill +1 moredrug
Likely dose
Cardiovascular Polypill 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02596126
NCT02596126Phase 3Completed
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Secondary Prevention of Cardiovascular Disease in the Elderly Trial

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III·interventional·Posted Nov 4, 2015·Updated May 23, 2025

In Brief

A Phase 3 clinical trial evaluating Cardiovascular Polypill and Treatment Prevention for Secondary CV for Myocardial Infarction and Cardiovascular Disease. Completed, enrolled 2,499 participants across 113 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyocardial Infarction, Cardiovascular Disease
CountriesCzechia, France, Germany, Hungary, Italy, Poland, Spain
CollaboratorsCharite University, Berlin, Germany, Centre Hospitalier Universitaire de Besancon, Wroclaw Medical University, Semmelweis University, General University Hospital, Prague, Servicio Madrileño de Salud, Madrid, Spain, London School of Hygiene and Tropical Medicine, Ferrer Internacional S.A., Istituto Di Ricerche Farmacologiche Mario Negri

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 4, 2015
Enrollment StartJul 1, 2016
Primary CompletionOct 31, 2021
Study CompletionMar 31, 2022
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 10.7 years ago

Interventions

Cardiovascular Polypilldrug

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 CVdrug

ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.