Secondary Prevention of Cardiovascular Disease in the Elderly Trial

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.

Conditions

• Myocardial Infarction
• Cardiovascular Disease

Interventions

DRUG

Cardiovascular Polypill

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).

DRUG

Treatment Prevention for Secondary CV

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

Sponsors & Collaborators

• Charite University, Berlin, Germany

  collaborator OTHER

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• Wroclaw Medical University

  collaborator OTHER

• Semmelweis University

  collaborator OTHER

• General University Hospital, Prague

  collaborator OTHER

• Servicio Madrileño de Salud, Madrid, Spain

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Ferrer Internacional S.A.

  collaborator INDUSTRY

• Istituto Di Ricerche Farmacologiche Mario Negri

  collaborator OTHER

• Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

  lead OTHER

Principal Investigators

• Valentin Fuster, MD, PhD · Centro Nacional de Investigaciones Cardiovasculares Carlos III

• Jose Maria Castellano Vazquez, MD, PhD · Centro Nacional de Investigaciones Cardiovasculares Carlos III

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2021-10-31

Completion

2022-03-31

Countries

• Czechia
• France
• Germany
• Hungary
• Italy
• Poland
• Spain

Study Locations