Clinical trial NCT01321255: Fixed Dose Combination Drug (Polypill)for Secondary Cardiovascular Prevention.
Official title: Improving Equitable Acces and Adherence to Secondary Prevention Therapy With a Fixed-Dose Combination Drug
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Keywords: Myocardial Infarction
Treatment Adherence
Lead sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Sponsor class: OTHER
Collaborators: name: Mario Negri Institute for Pharmacological Research
name: Rusculleda Foundation Instituto DAMIC
name: Fundacion Clinic per a la Recerca Biomédica
name: ARTTIC International Management Services
name: Federación Argentina de Cardiología FAC
name: World Health Organization
name: Instituto de Salud Carlos III
name: Ferrer Internacional S.A.
First posted: 2011-03-23
Enrollment: 2118
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Proportion of patients receiving AAS, an ACE inhibitor and a statin among those without contraindications to any of these drugs Adherence to treatment measured by: Morinsky-Green test and Pill accountability.
timeFrame: 18 months
measure: Adherence to treatment measured by the Morisky-Green questionnaire
timeFrame: 18 months
measure: Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months.
timeFrame: 18 months
measure: Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC)
timeFrame: 18 months
Secondary outcomes:
measure: Blood Pressure and Lipid Profile (LDL-cholesterol) at 1 and 9 months
timeFrame: 18 months
measure: Safety and tolerability: Adverse events and rate of treatment withdrawal.
timeFrame: 18 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Sanatorio Güemes
city: Buenos Aires
country: Argentina
facility: CENUDIAB
city: Córdoba
country: Argentina
facility: Centro Médico GEA 3 Privado
city: Córdoba
country: Argentina
facility: Hospital San Roque
city: Córdoba
country: Argentina
facility: Hospital Nuestra Señora de la Misericordia
city: Córdoba
country: Argentina
facility: Clínica Colombo
city: Córdoba
country: Argentina
facility: Instituto Médico DAMIC
city: Córdoba
country: Argentina
facility: Hospital Italiano
city: Córdoba
country: Argentina
facility: Hospital de Córdoba
city: Córdoba
country: Argentina
facility: Sanatorio Parque S.A.
city: Córdoba
country: Argentina
facility: IPAC - Clínica Privada Caraffa S.R.L.
city: Haedo
country: Argentina
facility: Consultan Salud S.A.
city: La Plata
country: Argentina
facility: Hospital Italiano
city: La Plata
country: Argentina
facility: Fundación CICLO
city: Morón
country: Argentina
facility: Clínica Constituyentes
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clínicas Quilmes
city: Ramos Mejía
country: Argentina
facility: DIM Clínica Privada
city: Rosario
country: Argentina
facility: Sanatorio Británico S.A.
city: Rosario
country: Argentina
facility: Hospital Italiano de Rosario Garibaldi
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
city: Rosario
country: Argentina
facility: Sanatorio Julio Corzo
city: San Martín
country: Argentina
facility: Corporación Médica General San Martín
city: Villa Allende
country: Argentina
facility: Clínica Privada de la Ciudad S.R.L.
city: Villa María
country: Argentina
facility: Sanatorio Cruz Azul S.R.L.
city: Villa María
country: Argentina
facility: Clínica Privada de Especialidades de Villa María S.R.L.
city: Sao Paulo
country: Brazil
facility: INOVAR Pesquisas clínicas
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisa SeÇão de Hipeertensão e Nefrología - Instituto Dante Pazzanese
city: Sao Paulo
country: Brazil
facility: Nefrología Centro de Pesquisa Clínica do Hospital do Rim e Hipertensão
city: Sao Paulo
country: Brazil
facility: UNIFESP - Setor de Lípides, Atersclerose e Biologia Vascular
city: Sao Paulo
country: Brazil
facility: Faculdade de Medicina da Universidade de Sao Paulo
city: Casarano
country: Italy
facility: Ospedale F. Ferrari
city: Cremona
country: Italy
facility: Azienda Istituti Ospitalieri
city: Desio
country: Italy
facility: Presidio Ospedaliero di Desio
city: Gallipoli
country: Italy
facility: Ospedale S. Cuore di Gesù
city: Isernia
country: Italy
facility: Ospedale F. Veneziale
city: Milano
country: Italy
facility: Ospedale Niguarda Cá Granda
city: Monza
country: Italy
facility: Azienda Ospedaler San Gerardo
city: Paola
country: Italy
facility: Ospedale Civile San Francesco di Paola
city: Passirana di Rho
country: Italy
facility: Azienda Ospedale G. Salvani - Presidio di Passirana
city: Pavia
country: Italy
facility: Ospedale Fondazione Salvatore Maugeri
city: San Daniele
country: Italy
facility: Ospedale Sant´ Antonio
city: Sarzana
country: Italy
facility: Ospedale San Bartolomeo
city: Sondrio
country: Italy
facility: Presidio Ospedaliero di Sondrio
city: Trento
country: Italy
facility: Casa di Cura - Villa Bianca
city: Asunción
country: Paraguay
facility: Hospital Central del Instituto de Previsión Social (HC-IPS)
city: Asunción
country: Paraguay
facility: Hospital Universitario Nuestra Señora de la Asunción
city: Asunción
country: Paraguay
facility: Hospitalñ de Clínicas - Catedra de Semiologia Médica - Universidad Nacional de Asunción
city: Itaugua
country: Paraguay
facility: Hospital Nacional de Itagua
city: Alcalá de Henares
country: Spain
facility: Hospital Principes de Asturias
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
city: Aldaya
country: Spain
facility: CS Aldaia
state: Valencia
city: Cheste
country: Spain
facility: CS Cheste
state: Valencia
city: Manises
country: Spain
facility: CS Manises
state: Valencia
city: Ribarroja
country: Spain
facility: CS Ribarroja del Túria
state: Valencia
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: EAP Poble Sec
city: Barcelona
country: Spain
facility: CAP Vallcarca
city: Barcelona
country: Spain
facility: ABS Gaudi
city: Barcelona
country: Spain
facility: EAP Sardenya
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Barcelona
country: Spain
facility: EAP Sarrià
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: CS Ángela Uriarte
city: Madrid
country: Spain
facility: CS San Andrés III
city: Madrid
country: Spain
facility: CS Villablanca
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Murcia
country: Spain
facility: Hospital Virgen Arrixaca
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
Study officials:
affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III
name: Valentín Fuster, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III
name: Ginés Sanz, MD PhD
role: STUDY_DIRECTOR
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