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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01321255
First received: March 21, 2011
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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


Enrollment: 2118
Study Start Date: January 2012
Study Completion Date: June 2014
Primary Completion Date: May 2014 (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.
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT01321255

  Hide Study Locations
Locations
Argentina
CENUDIAB
Buenos Aires, Argentina, C1440AAD
Sanatorio Güemes
Buenos Aires, Argentina, C1180AAX
Hospital San Roque
Córdoba, Argentina, X5000EPU
IPAC - Clínica Privada Caraffa S.R.L.
Córdoba, Argentina, X5008KKF
Instituto Médico DAMIC
Córdoba, Argentina, X5003DCE
Hospital Italiano
Córdoba, Argentina, X5004BAL
Sanatorio Parque S.A.
Córdoba, Argentina, X5006IKK
Centro Médico GEA 3 Privado
Córdoba, Argentina, X5000BSQ
Hospital Nuestra Señora de la Misericordia
Córdoba, Argentina, X5000JRD
Hospital de Córdoba
Córdoba, Argentina, X5004COT
Clínica Colombo
Córdoba, Argentina, X5002AOQ
Consultan Salud S.A.
Haedo, Argentina, B1706AJU
Fundación CICLO
La Plata, Argentina, B1902AGY
Hospital Italiano
La Plata, Argentina, B1900AXI
Clínica Constituyentes
Morón, Argentina, B1708KCH
Instituto de Investigaciones Clínicas Quilmes
Quilmes, Argentina, B1878GEG
DIM Clínica Privada
Ramos Mejía, Argentina, B1704ETD
Hospital Provincial del Centenario
Rosario, Argentina, S2002KDS
Sanatorio Británico S.A.
Rosario, Argentina, S2000CVB
Sanatorio Julio Corzo
Rosario, Argentina, S2002OUR
Hospital Italiano de Rosario Garibaldi
Rosario, Argentina, S2001ODA
Corporación Médica General San Martín
San Martín, Argentina, B1650CSQ
Clínica Privada de la Ciudad S.R.L.
Villa Allende, Argentina, X5105EQH
Sanatorio Cruz Azul S.R.L.
Villa María, Argentina, X5900EBG
Clínica Privada de Especialidades de Villa María S.R.L.
Villa María, Argentina, X5901ACG
Brazil
INOVAR Pesquisas clínicas
Sao Paulo, Brazil, 04012-060
Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, Brazil
Centro de Pesquisa SeÇão de Hipeertensão e Nefrología - Instituto Dante Pazzanese
Sao Paulo, Brazil, 04012-180
Nefrología Centro de Pesquisa Clínica do Hospital do Rim e Hipertensão
Sao Paulo, Brazil, 04025-011
UNIFESP - Setor de Lípides, Atersclerose e Biologia Vascular
Sao Paulo, Brazil, 04039-030
Italy
Ospedale F. Ferrari
Casarano, Italy, 73042
Azienda Istituti Ospitalieri
Cremona, Italy, 26100
Presidio Ospedaliero di Desio
Desio, Italy, 20832
Ospedale S. Cuore di Gesù
Gallipoli, Italy, 73014
Ospedale F. Veneziale
Isernia, Italy, 86170
Ospedale Niguarda Cá Granda
Milano, Italy, 20159
Azienda Ospedaler San Gerardo
Monza, Italy, 20900
Ospedale Civile San Francesco di Paola
Paola, Italy, 87027
Azienda Ospedale G. Salvani - Presidio di Passirana
Passirana di Rho, Italy, 20017
Ospedale Fondazione Salvatore Maugeri
Pavia, Italy, 27100
Ospedale Sant´ Antonio
San Daniele, Italy, 33038
Ospedale San Bartolomeo
Sarzana, Italy, 19038
Presidio Ospedaliero di Sondrio
Sondrio, Italy, 23100
Casa di Cura - Villa Bianca
Trento, Italy, 38100
Paraguay
Hospitalñ de Clínicas - Catedra de Semiologia Médica - Universidad Nacional de Asunción
Asunción, Paraguay
Hospital Universitario Nuestra Señora de la Asunción
Asunción, Paraguay
Hospital Central del Instituto de Previsión Social (HC-IPS)
Asunción, Paraguay
Hospital Nacional de Itagua
Itaugua, Paraguay
Spain
Hospital Principes de Asturias
Alcalá de Henares, Madrid, Spain, 28802
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
CS Aldaia
Aldaya, Valencia, Spain, 46960
CS Cheste
Cheste, Valencia, Spain, 46380
CS Manises
Manises, Valencia, Spain, 46940
CS Ribarroja del Túria
Ribarroja, Valencia, Spain, 46190
Hospital General de Alicante
Alicante, Spain, 03010
EAP Poble Sec
Barcelona, Spain, 08004
EAP Sarrià
Barcelona, Spain, 08034
EAP Sardenya
Barcelona, Spain, 08025
CAP Vallcarca
Barcelona, Spain, 08023
Hospital Clinic
Barcelona, Spain, 08036
ABS Gaudi
Barcelona, Spain, 08025
Hospital Sant Pau
Barcelona, Spain, 08025
CS Ángela Uriarte
Madrid, Spain, 28018
CS Villablanca
Madrid, Spain, 28032
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital La Princesa
Madrid, Spain, 28006
CS San Andrés III
Madrid, Spain, 28021
Hospital Virgen Arrixaca
Murcia, Spain, 30120
Hospital Virgen Macarena
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.
Investigators
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 ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
ClinicalTrials.gov 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: July 14, 2014
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:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Aspirin
Ramipril
Simvastatin
Analgesics
Analgesics, Non-Narcotic
Angiotensin-Converting Enzyme Inhibitors
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticholesteremic Agents
Antihypertensive Agents
Antimetabolites
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014