Fixed Dose Combination Drug (Polypill)for Secondary Cardiovascular Prevention.
- Conditions
- Myocardial Infarction
- Interventions
- Drug: Separately drugs, simvastatin, aspirin and ramipril
- Registration Number
- NCT01321255
- Lead Sponsor
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2118
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FDC Fixed Dose Combination FDC - Conventional treatment Separately drugs, simvastatin, aspirin and ramipril -
- Primary Outcome Measures
Name Time Method Adherence to treatment measured by the Morisky-Green questionnaire 18 months Phase 1:
Adherence to treatment measured by the Morisky-Green questionnaire. According to this, patients will be classified as "Good adherents" when the total score ranges between 16 and 20 and as "Poor adherents" if the total score is \<16 pointsTreatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months. 18 months Phase 2
Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) 18 months Phase 2
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. 18 months Phase 1
- Secondary Outcome Measures
Name Time Method Safety and tolerability: Adverse events and rate of treatment withdrawal. 18 months Phase 2
Blood Pressure and Lipid Profile (LDL-cholesterol) at 1 and 9 months 18 months Phase 2
Trial Locations
- Locations (68)
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
DIM Clínica Privada
🇦🇷Ramos Mejía, Argentina
Ospedale F. Veneziale
🇮🇹Isernia, Italy
Ospedale Civile San Francesco di Paola
🇮🇹Paola, Italy
Centro de Pesquisa SeÇão de Hipeertensão e Nefrología - Instituto Dante Pazzanese
🇧🇷Sao Paulo, Brazil
Clínica Privada de Especialidades de Villa María S.R.L.
🇦🇷Villa María, Argentina
Hospital Italiano
🇦🇷La Plata, Argentina
Presidio Ospedaliero di Sondrio
🇮🇹Sondrio, Italy
INOVAR Pesquisas clínicas
🇧🇷Sao Paulo, Brazil
UNIFESP - Setor de Lípides, Atersclerose e Biologia Vascular
🇧🇷Sao Paulo, Brazil
Hospital Principes de Asturias
🇪🇸Alcalá de Henares, Madrid, Spain
Hospital Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital de Córdoba
🇦🇷Córdoba, Argentina
Instituto de Investigaciones Clínicas Quilmes
🇦🇷Quilmes, Argentina
Azienda Istituti Ospitalieri
🇮🇹Cremona, Italy
Ospedale Niguarda Cá Granda
🇮🇹Milano, Italy
CS Ángela Uriarte
🇪🇸Madrid, Spain
Hospital Clinic
🇪🇸Barcelona, Spain
ABS Gaudi
🇪🇸Barcelona, Spain
Sanatorio Güemes
🇦🇷Buenos Aires, Argentina
Hospital San Roque
🇦🇷Córdoba, Argentina
Clínica Colombo
🇦🇷Córdoba, Argentina
Ospedale F. Ferrari
🇮🇹Casarano, Italy
Presidio Ospedaliero di Desio
🇮🇹Desio, Italy
Ospedale S. Cuore di Gesù
🇮🇹Gallipoli, Italy
CS Cheste
🇪🇸Cheste, Valencia, Spain
Nefrología Centro de Pesquisa Clínica do Hospital do Rim e Hipertensão
🇧🇷Sao Paulo, Brazil
CS Manises
🇪🇸Manises, Valencia, Spain
CAP Vallcarca
🇪🇸Barcelona, Spain
EAP Sarrià
🇪🇸Barcelona, Spain
Centro Médico GEA 3 Privado
🇦🇷Córdoba, Argentina
Instituto Médico DAMIC
🇦🇷Córdoba, Argentina
Sanatorio Parque S.A.
🇦🇷Córdoba, Argentina
IPAC - Clínica Privada Caraffa S.R.L.
🇦🇷Córdoba, Argentina
Clínica Constituyentes
🇦🇷Morón, Argentina
Hospital La Princesa
🇪🇸Madrid, Spain
Azienda Ospedale G. Salvani - Presidio di Passirana
🇮🇹Passirana di Rho, Italy
CS San Andrés III
🇪🇸Madrid, Spain
Hospital General de Alicante
🇪🇸Alicante, Spain
CS Aldaia
🇪🇸Aldaya, Valencia, Spain
Hospital Sant Pau
🇪🇸Barcelona, Spain
CS Ribarroja del Túria
🇪🇸Ribarroja, Valencia, Spain
EAP Sardenya
🇪🇸Barcelona, Spain
Azienda Ospedaler San Gerardo
🇮🇹Monza, Italy
Ospedale Fondazione Salvatore Maugeri
🇮🇹Pavia, Italy
Ospedale San Bartolomeo
🇮🇹Sarzana, Italy
Casa di Cura - Villa Bianca
🇮🇹Trento, Italy
CENUDIAB
🇦🇷Buenos Aires, Argentina
Hospital Nuestra Señora de la Misericordia
🇦🇷Córdoba, Argentina
Faculdade de Medicina da Universidade de Sao Paulo
🇧🇷Sao Paulo, Brazil
Ospedale Sant´ Antonio
🇮🇹San Daniele, Italy
EAP Poble Sec
🇪🇸Barcelona, Spain
CS Villablanca
🇪🇸Madrid, Spain
Hospital Virgen Arrixaca
🇪🇸Murcia, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Consultan Salud S.A.
🇦🇷Haedo, Argentina
Fundación CICLO
🇦🇷La Plata, Argentina
Sanatorio Británico S.A.
🇦🇷Rosario, Argentina
Hospital Italiano de Rosario Garibaldi
🇦🇷Rosario, Argentina
Clínica Privada de la Ciudad S.R.L.
🇦🇷Villa Allende, Argentina
Hospital Provincial del Centenario
🇦🇷Rosario, Argentina
Sanatorio Julio Corzo
🇦🇷Rosario, Argentina
Corporación Médica General San Martín
🇦🇷San Martín, Argentina
Sanatorio Cruz Azul S.R.L.
🇦🇷Villa María, Argentina
Hospital Central del Instituto de Previsión Social (HC-IPS)
🇵🇾Asunción, Paraguay
Hospitalñ de Clínicas - Catedra de Semiologia Médica - Universidad Nacional de Asunción
🇵🇾Asunción, Paraguay
Hospital Universitario Nuestra Señora de la Asunción
🇵🇾Asunción, Paraguay
Hospital Nacional de Itagua
🇵🇾Itaugua, Paraguay