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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Mario Negri Institute for Pharmacological Research
Rusculleda Foundation Instituto DAMIC
Fundacion Clinic per a la Recerca Biomédica
ARTTIC International Management Services
Federación Argentina de Cardiología FAC
World Health Organization
Instituto de Salud Carlos III
Ferrer Internacional S.A.
Information provided by (Responsible Party):
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III Identifier:
First received: March 21, 2011
Last updated: February 12, 2013
Last verified: February 2013

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.

Condition Intervention Phase
Myocardial Infarction
Drug: FDC
Drug: Separately drugs, simvastatin, aspirin and ramipril
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Improving Equitable Acces and Adherence to Secondary Prevention Therapy With a Fixed-Dose Combination Drug

Resource links provided by NLM:

Further study details as provided by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III:

Primary Outcome Measures:
  • 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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase 1

  • Adherence to treatment measured by the Morisky-Green questionnaire [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    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 points

  • Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase 2

  • Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase 2

Secondary Outcome Measures:
  • Blood Pressure and Lipid Profile (LDL-cholesterol) at 1 and 9 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase 2

  • Safety and tolerability: Adverse events and rate of treatment withdrawal. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Phase 2

Estimated Enrollment: 4000
Study Start Date: January 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FDC Fixed Dose Combination Drug: FDC
FDC includes a combination of 100 mg aspirin, 40 mg simvastatin, and 2.5;5;10 mg Ramipril
Active Comparator: Conventional treatment 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

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.

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01321255

Contact: Ginés Sanz, MD PhD +34 914531200
Contact: Luz Alvarez, Bch +34914531200 ext 4109

  Hide Study Locations
CENUDIAB Recruiting
Buenos Aires, Argentina, C1440AAD
Contact: Claudio R. Majul, MD   
Principal Investigator: Claudio R. Majul, MD         
Sanatorio Güemes Recruiting
Buenos Aires, Argentina, C1180AAX
Contact: Ricardo A. Villarreal, MD   
Principal Investigator: Ricardo A. Villarreal, MD         
Instituto Médico DAMIC Recruiting
Córdoba, Argentina, X5003DCE
Contact: Diego F. Martinez, MD   
Principal Investigator: Diego F. Martinez, MD         
Sanatorio Parque S.A. Recruiting
Córdoba, Argentina, X5006IKK
Contact: Hugo A. Lúquez, MD   
Principal Investigator: Hugo A. Lúquez, MD         
Hospital de Córdoba Recruiting
Córdoba, Argentina, X5004COT
Contact: Rodolfo J. Sarjanovich, MD   
Principal Investigator: Rodolfo J. Sarjanovich, MD         
IPAC - Clínica Privada Caraffa S.R.L. Recruiting
Córdoba, Argentina, X5008KKF
Contact: Guillermo Moises, MD   
Principal Investigator: Guillermo Moises, MD         
Hospital Nuestra Señora de la Misericordia Recruiting
Córdoba, Argentina, X5000JRD
Contact: Natalia Spitale, MD   
Principal Investigator: Natalia Spitale, MD         
Hospital San Roque Recruiting
Córdoba, Argentina, X5000EPU
Contact: Leonor Parody, MD   
Principal Investigator: Leonor Parody, MD         
Clínica Colombo Recruiting
Córdoba, Argentina, X5002AOQ
Contact: Hugo Colombo, MD   
Principal Investigator: Hugo Colombo, MD         
Hospital Italiano Recruiting
Córdoba, Argentina, X5004BAL
Contact: Horacio Simondi, MD   
Principal Investigator: Horacio Simondi, MD         
Centro Médico GEA 3 Privado Recruiting
Córdoba, Argentina, X5000BSQ
Contact: Eduardo M. Petenian, MD   
Principal Investigator: Eduardo M. Petenian, MD         
Consultan Salud S.A. Recruiting
Haedo, Argentina, B1706AJU
Contact: Javier C. Marino, MD   
Principal Investigator: Javier C. Marino, MD         
Hospital Italiano Recruiting
La Plata, Argentina, B1900AXI
Contact: Luis Cartasegna, MD   
Principal Investigator: Luis Cartasegna, MD         
Fundación CICLO Recruiting
La Plata, Argentina, B1902AGY
Contact: Ricardo López, MD   
Principal Investigator: Ricardo López, MD         
Clínica Constituyentes Recruiting
Morón, Argentina, B1708KCH
Contact: Daniel Nul, MD   
Principal Investigator: Daniel Nul, MD         
Instituto de Investigaciones Clínicas Quilmes Recruiting
Quilmes, Argentina, B1878GEG
Contact: Alberto A. Fernández, MD   
Principal Investigator: Alberto A. Fernández, MD         
DIM Clínica Privada Recruiting
Ramos Mejía, Argentina, B1704ETD
Contact: OScar R. Montaña, MD   
Principal Investigator: Oscar R. Montaña, MD         
Hospital Provincial del Centenario Recruiting
Rosario, Argentina, S2002KDS
Contact: Juan S. Beloscar, MD   
Principal Investigator: Juan S. Beloscar, MD         
Sanatorio Británico S.A. Recruiting
Rosario, Argentina, S2000CVB
Contact: Daniel L. Piskorz, MD   
Principal Investigator: Daniel L. Piskorz, MD         
Hospital Italiano de Rosario Garibaldi Recruiting
Rosario, Argentina, S2001ODA
Contact: Néstor A. Víta, MD   
Principal Investigator: Néstor A. Víta, MD         
Sanatorio Julio Corzo Recruiting
Rosario, Argentina, S2002OUR
Contact: Juan C. Linares, MD   
Principal Investigator: Juan C. Linares, MD         
Corporación Médica General San Martín Recruiting
San Martín, Argentina, B1650CSQ
Contact: Rodolfo A. Ahuad, MD   
Principal Investigator: Rodolfo A. Ahuad, MD         
Clínica Privada de la Ciudad S.R.L. Recruiting
Villa Allende, Argentina, X5105EQH
Contact: Luz M. Ibañez, MD   
Principal Investigator: Luz M. Ibañez, MD         
Sanatorio Cruz Azul S.R.L. Recruiting
Villa María, Argentina, X5900EBG
Contact: Martín Castro, MD   
Principal Investigator: Martín Castro, MD         
Clínica Privada de Especialidades de Villa María S.R.L. Recruiting
Villa María, Argentina, X5901ACG
Contact: Eleonora Montenegro, MD   
Principal Investigator: Eleonora Montenegro, MD         
INOVAR Pesquisas clínicas Recruiting
Sao Paulo, Brazil, 04012-060
Contact: Pedro S. Farsky, MD   
Principal Investigator: Pedro S. Farsky, MD         
Centro de Pesquisa SeÇão de Hipeertensão e Nefrología - Instituto Dante Pazzanese Recruiting
Sao Paulo, Brazil, 04012-180
Contact: Celso Amodeo, MD   
Principal Investigator: Celso Amodeo, MD         
Hospital e Maternida de Brasil Recruiting
Sao Paulo, Brazil, 09020110
Contact: Flavio A. de Oliveira, MD   
Principal Investigator: Flavio A. de Oliveira, MD         
Nefrología Centro de Pesquisa Clínica do Hospital do Rim e Hipertensão Recruiting
Sao Paulo, Brazil, 04025-011
Contact: Osvaldo J. Kohlmann, MD   
Principal Investigator: Osavaldo J. Kohlmann, MD         
Faculdade de Medicina da Universidade de Sao Paulo Recruiting
Sao Paulo, Brazil
Contact: Decio J. Mion, MD   
Principal Investigator: Decio J. Mion, MD         
UNIFESP - Setor de Lípides, Atersclerose e Biologia Vascular Recruiting
Sao Paulo, Brazil, 04039-030
Contact: Francisco A. Helfenstein, MD   
Principal Investigator: Francisco A. Helfenstein, MD         
Hospital Beneficencia Portuguesa SP - FGM - Clínica Paulista de Doenças Cardiovasculares Recruiting
Sao Paulo, Brazil, 01327-010
Contact: Fernando A. Alves da Costa, MD   
Principal Investigator: Fernando A. Alves da Costa, MD         
Ospedali Riuniti Albano-Genzano Recruiting
Albano Laziale, Italy, 00041
Contact: Giuseppe Pajes, MD   
Principal Investigator: Giuseppe Pajes, MD         
Ospedale Maggiore C.A. Pizzardi Azienda Usl di Bologna Recruiting
Bologna, Italy, 40133
Contact: Massimo Palmieri, MD   
Principal Investigator: Massimo Palmieri, MD         
Ospedale F. Ferrari Recruiting
Casarano, Italy, 73042
Contact: Ciricugno Santo Antonio, MD   
Principal Investigator: Ciricugno Santo Antonio, MD         
Azienda Istituti Ospitalieri Recruiting
Cremona, Italy, 26100
Contact: Silvia Frattini, MD   
Principal Investigator: Silvia Frattini, MD         
Presidio Ospedaliero di Desio Recruiting
Desio, Italy, 20832
Contact: Fausto Avanzini, MD   
Principal Investigator: Fausto Avanzini, MD         
Ospedale S. Cuore di Gesù Recruiting
Gallipoli, Italy, 73014
Contact: Francesco Mariello, MD   
Principal Investigator: Francesco Mariello, MD         
Ospedale F. Veneziale Recruiting
Isernia, Italy, 86170
Contact: Carlo Olivieri, MD   
Principal Investigator: Carlo Olivieri, MD         
OSpedale Mater Salutis Azienda Recruiting
Legnano, Italy, 37045
Contact: Paola Guarise, MD   
Principal Investigator: Paola Guarise, MD         
Ospedale Francesco Lastaria Recruiting
Lucera, Italy, 71036
Contact: Maggi Alessandro, MD   
Principal Investigator: Maggi Alessandro, MD         
Ospedale Niguarda Cá Granda Recruiting
Milano, Italy, 20159
Contact: Tiziana Pupilella, MD   
Principal Investigator: Tiziana Pupilella, MD         
Azienda Ospedaler San Gerardo Recruiting
Monza, Italy, 20900
Contact: Paola Camisasca, MD   
Principal Investigator: Paola Camisasca, MD         
Ospedale Civile San Francesco di Paola Recruiting
Paola, Italy, 87027
Contact: Andrea Crivaro, MD   
Principal Investigator: Andrea Crivaro, MD         
Azienda Ospedale G. Salvani - Presidio di Passirana Recruiting
Passirana di Rho, Italy, 20017
Contact: Anna Frisinghelli, MD   
Principal Investigator: Anna Frisinghelli, MD         
Ospedale Fondazione Salvatore Maugeri Recruiting
Pavia, Italy, 27100
Contact: Mariarosa Perotti, MD   
Principal Investigator: Mariarosa Perotti, MD         
Ospedale Sant´ Antonio Recruiting
San Daniele, Italy, 33038
Contact: Lucio Mos, MD   
Principal Investigator: Lucio Mos, MD         
Ospedale San Bartolomeo Recruiting
Sarzana, Italy, 19038
Contact: Rossella Petacchi, MD   
Principal Investigator: Rossella Petacchi, MD         
Presidio Ospedaliero di Sondrio Recruiting
Sondrio, Italy, 23100
Contact: Gianfranco Cucchi, MD   
Principal Investigator: Gianfranco Cucchi, MD         
Azienda Sanitaria Locale nº 4 Regione Umbria Recruiting
Terni, Italy, 05100
Contact: Marino Bernardinangeli, MD   
Principal Investigator: Marino Bernandinangeli, MD         
Casa di Cura - Villa Bianca Recruiting
Trento, Italy, 38100
Contact: Giovanni Cioffi, MD   
Principal Investigator: Giovanni Cioffi, MD         
Ospedale Chiarenzi Recruiting
Zevio, Italy, 37059
Contact: Ennio Li Greci, MD   
Principal Investigator: Ennio Li Greci, MD         
Hospital Central del Instituto de Previsión Social (HC-IPS) Recruiting
Asunción, Paraguay
Contact: Abdón Villamayor, MD   
Principal Investigator: Abdón Villamayor, MD         
Hospital Universitario Nuestra Señora de la Asunción Recruiting
Asunción, Paraguay
Contact: Miguel Adorno, MD   
Principal Investigator: Miguel Adorno, MD         
Hospitalñ de Clínicas - Catedra de Semiologia Médica - Universidad Nacional de Asunción Recruiting
Asunción, Paraguay
Contact: Javier Galeano, MD   
Principal Investigator: Javier Galeano, MD         
Hospital Nacional de Itagua Recruiting
Itaugua, Paraguay
Contact: Carlos R. Colman, MD   
Principal Investigator: Raul C. Colman, MD         
Sub-Investigator: Mabel Valdovinos, MD         
Hospital Principes de Asturias Active, not recruiting
Alcalá de Henares, Madrid, Spain, 28802
Hospital Severo Ochoa Active, not recruiting
Leganes, Madrid, Spain, 28911
Hospital Puerta de Hierro Active, not recruiting
Majadahonda, Madrid, Spain, 28222
CS Aldaia Recruiting
Aldaya, Valencia, Spain, 46960
Contact: María P. Palop, MD   
Principal Investigator: María P. Palop, MD         
CS Cheste Recruiting
Cheste, Valencia, Spain, 46380
Contact: Esteban Rosero, MD   
Principal Investigator: Esteban Rosero, MD         
CS Manises Recruiting
Manises, Valencia, Spain, 46940
Contact: María D. Alfonso, MD   
Principal Investigator: María D. Alfonso, MD         
CS Quart de Poblet Withdrawn
Quart de Poblet, Valencia, Spain, 46930
CS Ribarroja del Túria Recruiting
Ribarroja, Valencia, Spain, 46190
Contact: Roberto Gorgues, MD   
Principal Investigator: Roberto Gorgues, MD         
CS Babel Withdrawn
Alicante, Spain, 03007
CS La Florida Withdrawn
Alicante, Spain, 03007
CS Cabo Huertas Withdrawn
Alicante, Spain, 03540
CS San Blas Recruiting
Alicante, Spain, 03005
Contact: Herman Schwarz, MD   
Principal Investigator: Herman Schwarz, MD         
Hospital General de Alicante Active, not recruiting
Alicante, Spain, 03010
Hospital Sant Pau Active, not recruiting
Barcelona, Spain, 08025
CAP Les Corts Recruiting
Barcelona, Spain, 08028
Contact: Jacinto Ortíz, MD   
Principal Investigator: Jacinto Ortíz, MD         
EAP Sarrià Recruiting
Barcelona, Spain, 08034
Contact: Roger Vinyeta, MD   
Principal Investigator: Roger Brotons, MD         
EAP Sardenya Recruiting
Barcelona, Spain, 08025
Contact: Carlos Brotons, MD   
Principal Investigator: Carlos Brotons, MD         
CAP Vallcarca Recruiting
Barcelona, Spain, 08023
Contact: Anna Altés, MD   
Principal Investigator: Anna Altés, MD         
ABS Gaudi Recruiting
Barcelona, Spain, 08025
Contact: Ana M. Pedro, MD   
Principal Investigator: Ana M. Pedro, MD         
ABS Sagrada Familia Withdrawn
Barcelona, Spain, 08025
Hospital Clinic Active, not recruiting
Barcelona, Spain, 08036
EAP Poble Sec Recruiting
Barcelona, Spain, 08004
Contact: Francesc Vila, MD   
Principal Investigator: Francesc Vila, MD         
Hospital Clinico San Carlos Active, not recruiting
Madrid, Spain, 28040
CS Espronceda Withdrawn
Madrid, Spain, 28003
CS Villablanca Recruiting
Madrid, Spain, 28032
Contact: Luis Egido, MD   
Principal Investigator: Luis Egido, MD         
CS Ángela Uriarte Recruiting
Madrid, Spain, 28018
Contact: José A. Pere, MD   
Principal Investigator: José A. Pere, MD         
Hospital La Princesa Active, not recruiting
Madrid, Spain, 28006
CS San Andrés III Recruiting
Madrid, Spain, 28021
Contact: José M. Molero, MD   
Principal Investigator: José M. Molero, MD         
Hospital Virgen Arrixaca Active, not recruiting
Murcia, Spain, 30120
Hospital Virgen Macarena Active, not recruiting
Sevilla, Spain, 41009
Sponsors and Collaborators
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Mario Negri Institute for Pharmacological Research
Rusculleda Foundation Instituto DAMIC
Fundacion Clinic per a la Recerca Biomédica
ARTTIC International Management Services
Federación Argentina de Cardiología FAC
World Health Organization
Instituto de Salud Carlos III
Ferrer Internacional S.A.
Principal Investigator: Valentín Fuster, MD PhD Centro Nacional de Investigaciones Cardiovasculares Carlos III
Study Director: Ginés Sanz, MD PhD Centro Nacional de Investigaciones Cardiovasculares Carlos III
  More Information

Additional Information:
CNIC  This link exits the site


Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III Identifier: NCT01321255     History of Changes
Other Study ID Numbers: FOCUS, 2010-022492-54, Health-F2-2009-241559
Study First Received: March 21, 2011
Last Updated: February 12, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III:
Myocardial Infarction
Treatment Adherence

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors processed this record on July 10, 2014