Back to resultsFixed Dose Combination Drug (Polypill)for Secondary Cardiovascular Prevention. (FOCUS)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FDC
Separately drugs, simvastatin, aspirin and ramipril
Sponsored by
About this trial
This is an interventional prevention trial for Myocardial Infarction focused on measuring Myocardial Infarction, Treatment Adherence
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.
Sites / Locations
- Sanatorio Güemes
- CENUDIAB
- Centro Médico GEA 3 Privado
- Hospital San Roque
- Hospital Nuestra Señora de la Misericordia
- Clínica Colombo
- Instituto Médico DAMIC
- Hospital Italiano
- Hospital de Córdoba
- Sanatorio Parque S.A.
- IPAC - Clínica Privada Caraffa S.R.L.
- Consultan Salud S.A.
- Hospital Italiano
- Fundación CICLO
- Clínica Constituyentes
- Instituto de Investigaciones Clínicas Quilmes
- DIM Clínica Privada
- Sanatorio Británico S.A.
- Hospital Italiano de Rosario Garibaldi
- Hospital Provincial del Centenario
- Sanatorio Julio Corzo
- Corporación Médica General San Martín
- Clínica Privada de la Ciudad S.R.L.
- Sanatorio Cruz Azul S.R.L.
- Clínica Privada de Especialidades de Villa María S.R.L.
- INOVAR Pesquisas clínicas
- Centro de Pesquisa SeÇão de Hipeertensão e Nefrología - Instituto Dante Pazzanese
- Nefrología Centro de Pesquisa Clínica do Hospital do Rim e Hipertensão
- UNIFESP - Setor de Lípides, Atersclerose e Biologia Vascular
- Faculdade de Medicina da Universidade de Sao Paulo
- Ospedale F. Ferrari
- Azienda Istituti Ospitalieri
- Presidio Ospedaliero di Desio
- Ospedale S. Cuore di Gesù
- Ospedale F. Veneziale
- Ospedale Niguarda Cá Granda
- Azienda Ospedaler San Gerardo
- Ospedale Civile San Francesco di Paola
- Azienda Ospedale G. Salvani - Presidio di Passirana
- Ospedale Fondazione Salvatore Maugeri
- Ospedale Sant´ Antonio
- Ospedale San Bartolomeo
- Presidio Ospedaliero di Sondrio
- Casa di Cura - Villa Bianca
- Hospital Central del Instituto de Previsión Social (HC-IPS)
- Hospital Universitario Nuestra Señora de la Asunción
- Hospitalñ de Clínicas - Catedra de Semiologia Médica - Universidad Nacional de Asunción
- Hospital Nacional de Itagua
- Hospital Principes de Asturias
- Hospital Puerta de Hierro
- CS Aldaia
- CS Cheste
- CS Manises
- CS Ribarroja del Túria
- Hospital General de Alicante
- EAP Poble Sec
- CAP Vallcarca
- ABS Gaudi
- EAP Sardenya
- Hospital Sant Pau
- EAP Sarrià
- Hospital Clinic
- Hospital La Princesa
- CS Ángela Uriarte
- CS San Andrés III
- CS Villablanca
- Hospital Clinico San Carlos
- Hospital Virgen Arrixaca
- Hospital Virgen Macarena
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FDC Fixed Dose Combination
Conventional treatment
Arm Description
Outcomes
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.
Phase 1
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
Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months.
Phase 2
Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC)
Phase 2
Secondary Outcome Measures
Blood Pressure and Lipid Profile (LDL-cholesterol) at 1 and 9 months
Phase 2
Safety and tolerability: Adverse events and rate of treatment withdrawal.
Phase 2
Full Information
NCT ID
NCT01321255
First Posted
March 21, 2011
Last Updated
July 14, 2014
Sponsor
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
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.
1. Study Identification
Unique Protocol Identification Number
NCT01321255
Brief Title
Fixed Dose Combination Drug (Polypill)for Secondary Cardiovascular Prevention.
Acronym
FOCUS
Official Title
Improving Equitable Acces and Adherence to Secondary Prevention Therapy With a Fixed-Dose Combination Drug
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
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.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial Infarction, Treatment Adherence
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FDC Fixed Dose Combination
Arm Type
Experimental
Arm Title
Conventional treatment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
FDC
Intervention Description
FDC includes a combination of 100 mg aspirin, 40 mg simvastatin, and 2.5;5;10 mg Ramipril
Intervention Type
Drug
Intervention Name(s)
Separately drugs, simvastatin, aspirin and ramipril
Intervention Description
Aspirin 100 mg once a day Ramipril 2.5; 5; 10 mg once a day Simvastatin 40 mg once a day
Primary Outcome Measure Information:
Title
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.
Description
Phase 1
Time Frame
18 months
Title
Adherence to treatment measured by the Morisky-Green questionnaire
Description
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
Time Frame
18 months
Title
Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months.
Description
Phase 2
Time Frame
18 months
Title
Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC)
Description
Phase 2
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Blood Pressure and Lipid Profile (LDL-cholesterol) at 1 and 9 months
Description
Phase 2
Time Frame
18 months
Title
Safety and tolerability: Adverse events and rate of treatment withdrawal.
Description
Phase 2
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentín Fuster, MD PhD
Organizational Affiliation
Centro Nacional de Investigaciones Cardiovasculares Carlos III
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ginés Sanz, MD PhD
Organizational Affiliation
Centro Nacional de Investigaciones Cardiovasculares Carlos III
Official's Role
Study Director
Facility Information:
Facility Name
Sanatorio Güemes
City
Buenos Aires
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
CENUDIAB
City
Buenos Aires
ZIP/Postal Code
C1440AAD
Country
Argentina
Facility Name
Centro Médico GEA 3 Privado
City
Córdoba
ZIP/Postal Code
X5000BSQ
Country
Argentina
Facility Name
Hospital San Roque
City
Córdoba
ZIP/Postal Code
X5000EPU
Country
Argentina
Facility Name
Hospital Nuestra Señora de la Misericordia
City
Córdoba
ZIP/Postal Code
X5000JRD
Country
Argentina
Facility Name
Clínica Colombo
City
Córdoba
ZIP/Postal Code
X5002AOQ
Country
Argentina
Facility Name
Instituto Médico DAMIC
City
Córdoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Hospital Italiano
City
Córdoba
ZIP/Postal Code
X5004BAL
Country
Argentina
Facility Name
Hospital de Córdoba
City
Córdoba
ZIP/Postal Code
X5004COT
Country
Argentina
Facility Name
Sanatorio Parque S.A.
City
Córdoba
ZIP/Postal Code
X5006IKK
Country
Argentina
Facility Name
IPAC - Clínica Privada Caraffa S.R.L.
City
Córdoba
ZIP/Postal Code
X5008KKF
Country
Argentina
Facility Name
Consultan Salud S.A.
City
Haedo
ZIP/Postal Code
B1706AJU
Country
Argentina
Facility Name
Hospital Italiano
City
La Plata
ZIP/Postal Code
B1900AXI
Country
Argentina
Facility Name
Fundación CICLO
City
La Plata
ZIP/Postal Code
B1902AGY
Country
Argentina
Facility Name
Clínica Constituyentes
City
Morón
ZIP/Postal Code
B1708KCH
Country
Argentina
Facility Name
Instituto de Investigaciones Clínicas Quilmes
City
Quilmes
ZIP/Postal Code
B1878GEG
Country
Argentina
Facility Name
DIM Clínica Privada
City
Ramos Mejía
ZIP/Postal Code
B1704ETD
Country
Argentina
Facility Name
Sanatorio Británico S.A.
City
Rosario
ZIP/Postal Code
S2000CVB
Country
Argentina
Facility Name
Hospital Italiano de Rosario Garibaldi
City
Rosario
ZIP/Postal Code
S2001ODA
Country
Argentina
Facility Name
Hospital Provincial del Centenario
City
Rosario
ZIP/Postal Code
S2002KDS
Country
Argentina
Facility Name
Sanatorio Julio Corzo
City
Rosario
ZIP/Postal Code
S2002OUR
Country
Argentina
Facility Name
Corporación Médica General San Martín
City
San Martín
ZIP/Postal Code
B1650CSQ
Country
Argentina
Facility Name
Clínica Privada de la Ciudad S.R.L.
City
Villa Allende
ZIP/Postal Code
X5105EQH
Country
Argentina
Facility Name
Sanatorio Cruz Azul S.R.L.
City
Villa María
ZIP/Postal Code
X5900EBG
Country
Argentina
Facility Name
Clínica Privada de Especialidades de Villa María S.R.L.
City
Villa María
ZIP/Postal Code
X5901ACG
Country
Argentina
Facility Name
INOVAR Pesquisas clínicas
City
Sao Paulo
ZIP/Postal Code
04012-060
Country
Brazil
Facility Name
Centro de Pesquisa SeÇão de Hipeertensão e Nefrología - Instituto Dante Pazzanese
City
Sao Paulo
ZIP/Postal Code
04012-180
Country
Brazil
Facility Name
Nefrología Centro de Pesquisa Clínica do Hospital do Rim e Hipertensão
City
Sao Paulo
ZIP/Postal Code
04025-011
Country
Brazil
Facility Name
UNIFESP - Setor de Lípides, Atersclerose e Biologia Vascular
City
Sao Paulo
ZIP/Postal Code
04039-030
Country
Brazil
Facility Name
Faculdade de Medicina da Universidade de Sao Paulo
City
Sao Paulo
Country
Brazil
Facility Name
Ospedale F. Ferrari
City
Casarano
ZIP/Postal Code
73042
Country
Italy
Facility Name
Azienda Istituti Ospitalieri
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Presidio Ospedaliero di Desio
City
Desio
ZIP/Postal Code
20832
Country
Italy
Facility Name
Ospedale S. Cuore di Gesù
City
Gallipoli
ZIP/Postal Code
73014
Country
Italy
Facility Name
Ospedale F. Veneziale
City
Isernia
ZIP/Postal Code
86170
Country
Italy
Facility Name
Ospedale Niguarda Cá Granda
City
Milano
ZIP/Postal Code
20159
Country
Italy
Facility Name
Azienda Ospedaler San Gerardo
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Ospedale Civile San Francesco di Paola
City
Paola
ZIP/Postal Code
87027
Country
Italy
Facility Name
Azienda Ospedale G. Salvani - Presidio di Passirana
City
Passirana di Rho
ZIP/Postal Code
20017
Country
Italy
Facility Name
Ospedale Fondazione Salvatore Maugeri
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale Sant´ Antonio
City
San Daniele
ZIP/Postal Code
33038
Country
Italy
Facility Name
Ospedale San Bartolomeo
City
Sarzana
ZIP/Postal Code
19038
Country
Italy
Facility Name
Presidio Ospedaliero di Sondrio
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Facility Name
Casa di Cura - Villa Bianca
City
Trento
ZIP/Postal Code
38100
Country
Italy
Facility Name
Hospital Central del Instituto de Previsión Social (HC-IPS)
City
Asunción
Country
Paraguay
Facility Name
Hospital Universitario Nuestra Señora de la Asunción
City
Asunción
Country
Paraguay
Facility Name
Hospitalñ de Clínicas - Catedra de Semiologia Médica - Universidad Nacional de Asunción
City
Asunción
Country
Paraguay
Facility Name
Hospital Nacional de Itagua
City
Itaugua
Country
Paraguay
Facility Name
Hospital Principes de Asturias
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28802
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
CS Aldaia
City
Aldaya
State/Province
Valencia
ZIP/Postal Code
46960
Country
Spain
Facility Name
CS Cheste
City
Cheste
State/Province
Valencia
ZIP/Postal Code
46380
Country
Spain
Facility Name
CS Manises
City
Manises
State/Province
Valencia
ZIP/Postal Code
46940
Country
Spain
Facility Name
CS Ribarroja del Túria
City
Ribarroja
State/Province
Valencia
ZIP/Postal Code
46190
Country
Spain
Facility Name
Hospital General de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
EAP Poble Sec
City
Barcelona
ZIP/Postal Code
08004
Country
Spain
Facility Name
CAP Vallcarca
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
ABS Gaudi
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
EAP Sardenya
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
EAP Sarrià
City
Barcelona
ZIP/Postal Code
08034
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
CS Ángela Uriarte
City
Madrid
ZIP/Postal Code
28018
Country
Spain
Facility Name
CS San Andrés III
City
Madrid
ZIP/Postal Code
28021
Country
Spain
Facility Name
CS Villablanca
City
Madrid
ZIP/Postal Code
28032
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Virgen Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
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Fixed Dose Combination Drug (Polypill)for Secondary Cardiovascular Prevention.
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