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

NCT01321255 | Completed Phase 3 DMC

• 3 other identifiers: FOCUS2010-022492-54Health-F2-2009-241559
• Study Type: interventional
• Target: 2,118
• Locations: 5 countries
• Sites: 69

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.

Conditions

Myocardial Infarction

Keywords

Myocardial Infarction; Treatment Adherence

Outcome Measures

Primary Outcomes (4)

• 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.

  Phase 1

  18 months

• Adherence to treatment measured by the Morisky-Green questionnaire

  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

  18 months

• Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months.

  Phase 2

  18 months

• Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC)

  Phase 2

  18 months

Secondary Outcomes (2)

• Blood Pressure and Lipid Profile (LDL-cholesterol) at 1 and 9 months

  18 months

• Safety and tolerability: Adverse events and rate of treatment withdrawal.

  18 months

Study Arms (2)

FDC Fixed Dose Combination

EXPERIMENTAL

Drug: FDC

Conventional treatment

ACTIVE COMPARATOR

Drug: Separately drugs, simvastatin, aspirin and ramipril

Interventions

FDC DRUG

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

FDC Fixed Dose Combination

Separately drugs, simvastatin, aspirin and ramipril DRUG

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

Conventional treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III: lead
• Mario Negri Institute for Pharmacological Research: collaborator
• Rusculleda Foundation Instituto DAMIC: collaborator
• Fundacion Clinic per a la Recerca Biomédica: collaborator
• ARTTIC International Management Services: collaborator
• Federación Argentina de Cardiología FAC: collaborator
• World Health Organization: collaborator
• Instituto de Salud Carlos III: collaborator
• Ferrer Internacional S.A.: collaborator

Study Sites (69)

Sanatorio Güemes

Buenos Aires, C1180AAX, Argentina

Location

CENUDIAB

Buenos Aires, C1440AAD, Argentina

Location

Centro Médico GEA 3 Privado

Córdoba, X5000BSQ, Argentina

Location

Hospital San Roque

Córdoba, X5000EPU, Argentina

Location

Hospital Nuestra Señora de la Misericordia

Córdoba, X5000JRD, Argentina

Location

Clínica Colombo

Córdoba, X5002AOQ, Argentina

Location

Instituto Médico DAMIC

Córdoba, X5003DCE, Argentina

Location

Hospital Italiano

Córdoba, X5004BAL, Argentina

Location

Hospital de Córdoba

Córdoba, X5004COT, Argentina

Location

Sanatorio Parque S.A.

Córdoba, X5006IKK, Argentina

Location

IPAC - Clínica Privada Caraffa S.R.L.

Córdoba, X5008KKF, Argentina

Location

Consultan Salud S.A.

Haedo, B1706AJU, Argentina

Location

Hospital Italiano

La Plata, B1900AXI, Argentina

Location

Fundación CICLO

La Plata, B1902AGY, Argentina

Location

Clínica Constituyentes

Morón, B1708KCH, Argentina

Location

Instituto de Investigaciones Clínicas Quilmes

Quilmes, B1878GEG, Argentina

Location

DIM Clínica Privada

Ramos Mejía, B1704ETD, Argentina

Location

Sanatorio Británico S.A.

Rosario, S2000CVB, Argentina

Location

Hospital Italiano de Rosario Garibaldi

Rosario, S2001ODA, Argentina

Location

Hospital Provincial del Centenario

Rosario, S2002KDS, Argentina

Location

Sanatorio Julio Corzo

Rosario, S2002OUR, Argentina

Location

Corporación Médica General San Martín

San Martín, B1650CSQ, Argentina

Location

Clínica Privada de la Ciudad S.R.L.

Villa Allende, X5105EQH, Argentina

Location

Sanatorio Cruz Azul S.R.L.

Villa María, X5900EBG, Argentina

Location

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

Villa María, X5901ACG, Argentina

Location

INOVAR Pesquisas clínicas

São Paulo, 04012-060, Brazil

Location

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

São Paulo, 04012-180, Brazil

Location

Nefrología Centro de Pesquisa Clínica do Hospital do Rim e Hipertensão

São Paulo, 04025-011, Brazil

Location

UNIFESP - Setor de Lípides, Atersclerose e Biologia Vascular

São Paulo, 04039-030, Brazil

Location

Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, Brazil

Location

Ospedale F. Ferrari

Casarano, 73042, Italy

Location

Azienda Istituti Ospitalieri

Cremona, 26100, Italy

Location

Presidio Ospedaliero di Desio

Desio, 20832, Italy

Location

Ospedale S. Cuore di Gesù

Gallipoli, 73014, Italy

Location

Ospedale F. Veneziale

Isernia, 86170, Italy

Location

Ospedale Niguarda Cá Granda

Milan, 20159, Italy

Location

Azienda Ospedaler San Gerardo

Monza, 20900, Italy

Location

Ospedale Civile San Francesco di Paola

Paola, 87027, Italy

Location

Azienda Ospedale G. Salvani - Presidio di Passirana

Passirana Di Rho, 20017, Italy

Location

Ospedale Fondazione Salvatore Maugeri

Pavia, 27100, Italy

Location

Ospedale Sant´ Antonio

San Daniele, 33038, Italy

Location

Ospedale San Bartolomeo

Sarzana, 19038, Italy

Location

Presidio Ospedaliero di Sondrio

Sondrio, 23100, Italy

Location

Casa di Cura - Villa Bianca

Trento, 38100, Italy

Location

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

Asunción, Paraguay

Location

Hospital Universitario Nuestra Señora de la Asunción

Asunción, Paraguay

Location

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

Asunción, Paraguay

Location

Hospital Nacional de Itagua

Itauguá, Paraguay

Location

Hospital Principes de Asturias

Alcalá de Henares, Madrid, 28802, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

CS Aldaia

Aldaia, Valencia, 46960, Spain

Location

CS Cheste

Cheste, Valencia, 46380, Spain

Location

CS Manises

Manises, Valencia, 46940, Spain

Location

CS Ribarroja del Túria

Ribarroja del Turia, Valencia, 46190, Spain

Location

Hospital General de Alicante

Alicante, 03010, Spain

Location

EAP Poble Sec

Barcelona, 08004, Spain

Location

CAP Vallcarca

Barcelona, 08023, Spain

Location

ABS Gaudi

Barcelona, 08025, Spain

Location

EAP Sardenya

Barcelona, 08025, Spain

Location

Hospital Sant Pau

Barcelona, 08025, Spain

Location

EAP Sarrià

Barcelona, 08034, Spain

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital La Princesa

Madrid, 28006, Spain

Location

CS Ángela Uriarte

Madrid, 28018, Spain

Location

CS San Andrés III

Madrid, 28021, Spain

Location

CS Villablanca

Madrid, 28032, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Virgen Arrixaca

Murcia, 30120, Spain

Location

Hospital Virgen Macarena

Seville, 41009, Spain

Location

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• Castellano JM, Sanz G, Penalvo JL, Bansilal S, Fernandez-Ortiz A, Alvarez L, Guzman L, Linares JC, Garcia F, D'Aniello F, Arnaiz JA, Varea S, Martinez F, Lorenzatti A, Imaz I, Sanchez-Gomez LM, Roncaglioni MC, Baviera M, Smith SC Jr, Taubert K, Pocock S, Brotons C, Farkouh ME, Fuster V. A polypill strategy to improve adherence: results from the FOCUS project. J Am Coll Cardiol. 2014 Nov 18-25;64(20):2071-82. doi: 10.1016/j.jacc.2014.08.021. Epub 2014 Sep 1.

  PMID: 25193393 DERIVED

• Sanz G, Fuster V, Guzman L, Guglietta A, Arnaiz JA, Martinez F, Sarria A, Roncaglioni MC, Taubert K. The fixed-dose combination drug for secondary cardiovascular prevention project: improving equitable access and adherence to secondary cardiovascular prevention with a fixed-dose combination drug. Study design and objectives. Am Heart J. 2011 Nov;162(5):811-817.e1. doi: 10.1016/j.ahj.2011.08.012.

  PMID: 22093195 DERIVED

Related Links

• CNIC

MeSH Terms

Conditions

Myocardial Infarction; Treatment Adherence and Compliance

Interventions

Simvastatin; Aspirin; Ramipril

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Valentín Fuster, MD PhD

  Centro Nacional de Investigaciones Cardiovasculares Carlos III

  PRINCIPAL INVESTIGATOR

• Ginés Sanz, MD PhD

  Centro Nacional de Investigaciones Cardiovasculares Carlos III

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 23, 2011
• Study Start: January 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 15, 2014

Record last verified: 2014-07

Locations

PA (4); BR (5); IT (14); AR (25); ES (21)