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

NCT ID: NCT01321255

Last Updated: 2014-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-06-30

Brief 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.

Detailed Description

The specific objective of the FOCUS project is to prove that:

1. Better knowledge of factors relates to inappropriate use of secondary cardiovascular prevention drugs and lack of adherence to treatment will help to design new strategies for improving patients' management.

2. A Fixed Dose Combination (FDC, polypill) including three components with a well demonstrated efficacy will improve secondary prevention in coronary patients by decreasing inappropriate prescribing and by reducing complexity of treatment and lack of adherence.

• Phase 1 is a descriptive, non-interventional study. Its aim is to provide a comprehensive analysis of potential factors precluding adequate secondary prevention, including Health system characteristics, drugs affordability and availability, as well as patients' characteristics. Differences between the two studied regions (Europe and South America) will be analyzed.
• Phase 2 is an interventional, randomized trial with prospective economic evaluation. It will be organised as a two-arm, randomised, parallel, multinational study. Patients completing the Phase 1, and fulfilling inclusion/exclusion criteria (see below), will be included in Phase 2. Patients will be randomized to receive a FDC of ramipril, simvastatin and acetylsalicylic acid or the three medications separately.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

FDC Fixed Dose Combination

Group Type: EXPERIMENTAL

FDC

Intervention Type: DRUG

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

Conventional treatment

Group Type: ACTIVE_COMPARATOR

Separately drugs, simvastatin, aspirin and ramipril

Intervention Type: DRUG

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

Interventions

FDC

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Phase 1: All patients, male and female, 40 years of age or older, with a history of ST-elevation AMI within the last 2 years, attending any of the selected sites and signing the consent
• Phase 2: All patients, male and female, 40 years of age or older, with a history of ST-elevation AMI within the last 2 years, attending any of the selected sites and signing the consent Patients in whom secondary prevention with ASA, statin and ACEI is indicated, Signing informed consent

Exclusion Criteria

• Phase 1: Patients in which any of the components of the FDC is contraindicated. Living in a nursing home. Memtal illness limiting the capacity of
• Phase 2:Secondary dyslipemia, Patients in which any of the components of the FDC is contraindicated, Living in a nursing home, Mental illness limiting the capacity of self care, Participating in another trial, , Previous Percutaneous Transluminal Coronary Angioplasty (PTCA) with a drug eluting stent (DES) whitin the last year, Severe Congestive Heart Failure (NYHA III-IV), Serum creatinine >2 mg/dl, any condition limiting life expectancy <2 years. Pregnant or premenopausal women.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role: collaborator

Rusculleda Foundation Instituto DAMIC

UNKNOWN

Sponsor Role: collaborator

Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role: collaborator

ARTTIC International Management Services

UNKNOWN

Sponsor Role: collaborator

Federación Argentina de Cardiología FAC

UNKNOWN

Sponsor Role: collaborator

World Health Organization

OTHER

Sponsor Role: collaborator

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Ferrer Internacional S.A.

INDUSTRY

Sponsor Role: collaborator

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valentín Fuster, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centro Nacional de Investigaciones Cardiovasculares Carlos III

Ginés Sanz, MD PhD

Role: STUDY_DIRECTOR

Centro Nacional de Investigaciones Cardiovasculares Carlos III

Locations

Sanatorio Güemes

Buenos Aires, , Argentina

CENUDIAB

Buenos Aires, , Argentina

Centro Médico GEA 3 Privado

Córdoba, , Argentina

Hospital San Roque

Córdoba, , Argentina

Hospital Nuestra Señora de la Misericordia

Córdoba, , Argentina

Clínica Colombo

Córdoba, , Argentina

Instituto Médico DAMIC

Córdoba, , Argentina

Hospital Italiano

Córdoba, , Argentina

Hospital de Córdoba

Córdoba, , Argentina

Sanatorio Parque S.A.

Córdoba, , Argentina

IPAC - Clínica Privada Caraffa S.R.L.

Córdoba, , Argentina

Consultan Salud S.A.

Haedo, , Argentina

Hospital Italiano

La Plata, , Argentina

Fundación CICLO

La Plata, , Argentina

Clínica Constituyentes

Morón, , Argentina

Instituto de Investigaciones Clínicas Quilmes

Quilmes, , Argentina

DIM Clínica Privada

Ramos Mejía, , Argentina

Sanatorio Británico S.A.

Rosario, , Argentina

Hospital Italiano de Rosario Garibaldi

Rosario, , Argentina

Hospital Provincial del Centenario

Rosario, , Argentina

Sanatorio Julio Corzo

Rosario, , Argentina

Corporación Médica General San Martín

San Martín, , Argentina

Clínica Privada de la Ciudad S.R.L.

Villa Allende, , Argentina

Sanatorio Cruz Azul S.R.L.

Villa María, , Argentina

Clínica Privada de Especialidades de Villa María S.R.L.

Villa María, , Argentina

INOVAR Pesquisas clínicas

São Paulo, , Brazil

Centro de Pesquisa SeÇão de Hipeertensão e Nefrología - Instituto Dante Pazzanese

São Paulo, , Brazil

Nefrología Centro de Pesquisa Clínica do Hospital do Rim e Hipertensão

São Paulo, , Brazil

UNIFESP - Setor de Lípides, Atersclerose e Biologia Vascular

São Paulo, , Brazil

Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, , Brazil

Ospedale F. Ferrari

Casarano, , Italy

Azienda Istituti Ospitalieri

Cremona, , Italy

Presidio Ospedaliero di Desio

Desio, , Italy

Ospedale S. Cuore di Gesù

Gallipoli, , Italy

Ospedale F. Veneziale

Isernia, , Italy

Ospedale Niguarda Cá Granda

Milan, , Italy

Azienda Ospedaler San Gerardo

Monza, , Italy

Ospedale Civile San Francesco di Paola

Paola, , Italy

Azienda Ospedale G. Salvani - Presidio di Passirana

Passirana Di Rho, , Italy

Ospedale Fondazione Salvatore Maugeri

Pavia, , Italy

Ospedale Sant´ Antonio

San Daniele, , Italy

Ospedale San Bartolomeo

Sarzana, , Italy

Presidio Ospedaliero di Sondrio

Sondrio, , Italy

Casa di Cura - Villa Bianca

Trento, , Italy

Hospital Central del Instituto de Previsión Social (HC-IPS)

Asunción, , Paraguay

Hospital Universitario Nuestra Señora de la Asunción

Asunción, , Paraguay

Hospitalñ de Clínicas - Catedra de Semiologia Médica - Universidad Nacional de Asunción

Asunción, , Paraguay

Hospital Nacional de Itagua

Itauguá, , Paraguay

Hospital Principes de Asturias

Alcalá de Henares, Madrid, Spain

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

CS Aldaia

Aldaia, Valencia, Spain

CS Cheste

Cheste, Valencia, Spain

CS Manises

Manises, Valencia, Spain

CS Ribarroja del Túria

Ribarroja del Turia, Valencia, Spain

Hospital General de Alicante

Alicante, , Spain

EAP Poble Sec

Barcelona, , Spain

CAP Vallcarca

Barcelona, , Spain

ABS Gaudi

Barcelona, , Spain

EAP Sardenya

Barcelona, , Spain

Hospital Sant Pau

Barcelona, , Spain

EAP Sarrià

Barcelona, , Spain

Hospital Clinic

Barcelona, , Spain

Hospital La Princesa

Madrid, , Spain

CS Ángela Uriarte

Madrid, , Spain

CS San Andrés III

Madrid, , Spain

CS Villablanca

Madrid, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Virgen Arrixaca

Murcia, , Spain

Hospital Virgen Macarena

Seville, , Spain

Countries

Argentina; Brazil; Italy; Paraguay; Spain

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Related Links

http://www.cnic.es/en/index.php

CNIC

Other Identifiers

2010-022492-54

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Health-F2-2009-241559

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FOCUS

Identifier Type: -

Identifier Source: org_study_id