Fixed Dose Combination Drug (Polypill)for Secondary Cardiovascular Prevention.

Summary

The aim of the FOCUS project is to test the Fixed Dose Combination concept for cardiovascular prevention in populations of different socio-economic characteristics. At the same time, FOCUS aims to understand the factors determining inappropriate prescribing for secondary cardiovascular prevention and those for poor patients adherence to treatment. This will allow FOCUS to establish recommendations for a better use of medication in patients with ischemic heart disease. In addition, after a successful completion of FOCUS, secondary prevention medication will be available and affordable for a large number of patients in both developed as well as developing countries.

There are two Phases in this study:

Phase 1: Is a descriptive, non interventional study. Phase 2: Is an interventional, randomized trial with prospective economic evaluation.

Conditions

• Myocardial Infarction

Interventions

DRUG

FDC

FDC includes a combination of 100 mg aspirin, 40 mg simvastatin, and 2.5;5;10 mg Ramipril

DRUG

Separately drugs, simvastatin, aspirin and ramipril

Aspirin 100 mg once a day Ramipril 2.5; 5; 10 mg once a day Simvastatin 40 mg once a day

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research

  collaborator OTHER

• Rusculleda Foundation Instituto DAMIC

  collaborator UNKNOWN

• Fundacion Clinic per a la Recerca Biomédica

  collaborator OTHER

• ARTTIC International Management Services

  collaborator UNKNOWN

• Federación Argentina de Cardiología FAC

  collaborator UNKNOWN

• World Health Organization

  collaborator OTHER

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Ferrer Internacional S.A.

  collaborator INDUSTRY

• Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

  lead OTHER

Principal Investigators

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

• Ginés Sanz, MD PhD · Centro Nacional de Investigaciones Cardiovasculares Carlos III

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2014-05-31

Completion

2014-06-30

Countries

• Argentina
• Brazil
• Italy
• Paraguay
• Spain

Study Locations