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Myocardial InfarctionPhase 3FOCUSNCT01321255

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

A Phase 3 study testing FDC and Separately drugs, simvastatin, aspirin and ramipril in people with Myocardial Infarction, run by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III at 69 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
FDC and Separately drugs, simvastatin, aspirin and ramipril
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,118 participants
Where
69 sitesin 5 countries
Study dates
Jan 2012to Jun 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

69 sites in 5 countries.

69 sites in 5 countries

Argentina25 sites

  • Sanatorio Güemes

    Buenos Aires, C1180AAX

  • CENUDIAB

    Buenos Aires, C1440AAD

  • Centro Médico GEA 3 Privado

    Córdoba, X5000BSQ

  • Hospital San Roque

    Córdoba, X5000EPU

  • Hospital Nuestra Señora de la Misericordia

    Córdoba, X5000JRD

  • Clínica Colombo

    Córdoba, X5002AOQ

  • Instituto Médico DAMIC

    Córdoba, X5003DCE

  • Hospital Italiano

    Córdoba, X5004BAL

  • Hospital de Córdoba

    Córdoba, X5004COT

  • Sanatorio Parque S.A.

    Córdoba, X5006IKK

  • IPAC - Clínica Privada Caraffa S.R.L.

    Córdoba, X5008KKF

  • Consultan Salud S.A.

    Haedo, B1706AJU

  • Hospital Italiano

    La Plata, B1900AXI

  • Fundación CICLO

    La Plata, B1902AGY

  • Clínica Constituyentes

    Morón, B1708KCH

  • Instituto de Investigaciones Clínicas Quilmes

    Quilmes, B1878GEG

  • DIM Clínica Privada

    Ramos Mejía, B1704ETD

  • Sanatorio Británico S.A.

    Rosario, S2000CVB

  • Hospital Italiano de Rosario Garibaldi

    Rosario, S2001ODA

  • Hospital Provincial del Centenario

    Rosario, S2002KDS

  • Sanatorio Julio Corzo

    Rosario, S2002OUR

  • Corporación Médica General San Martín

    San Martin, B1650CSQ

  • Clínica Privada de la Ciudad S.R.L.

    Villa Allende, X5105EQH

  • Sanatorio Cruz Azul S.R.L.

    Villa María, X5900EBG

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

    Villa María, X5901ACG

Other trials in Argentina

Spain21 sites

  • Hospital Principes de Asturias

    Alcalá de Henares, Madrid, 28802

  • CS Aldaia

    Aldaia, Valencia, 46960

  • Hospital General de Alicante

    Alicante, 03010

  • EAP Poble Sec

    Barcelona, 08004

  • CAP Vallcarca

    Barcelona, 08023

  • ABS Gaudi

    Barcelona, 08025

  • EAP Sardenya

    Barcelona, 08025

  • Hospital Sant Pau

    Barcelona, 08025

  • EAP Sarrià

    Barcelona, 08034

  • Hospital Clinic

    Barcelona, 08036

  • CS Cheste

    Cheste, Valencia, 46380

  • Hospital La Princesa

    Madrid, 28006

  • CS Ángela Uriarte

    Madrid, 28018

  • CS San Andrés III

    Madrid, 28021

  • CS Villablanca

    Madrid, 28032

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Puerta de Hierro

    Majadahonda, Madrid, 28222

  • CS Manises

    Manises, Valencia, 46940

  • Hospital Virgen Arrixaca

    Murcia, 30120

  • CS Ribarroja del Túria

    Ribarroja del Turia, Valencia, 46190

  • Hospital Virgen Macarena

    Seville, 41009

Other trials in Spain

Italy14 sites

  • Ospedale F. Ferrari

    Casarano, 73042

  • Azienda Istituti Ospitalieri

    Cremona, 26100

  • Presidio Ospedaliero di Desio

    Desio, 20832

  • Ospedale S. Cuore di Gesù

    Gallipoli, 73014

  • Ospedale F. Veneziale

    Isernia, 86170

  • Ospedale Niguarda Cá Granda

    Milan, 20159

  • Azienda Ospedaler San Gerardo

    Monza, 20900

  • Ospedale Civile San Francesco di Paola

    Paola, 87027

  • Azienda Ospedale G. Salvani - Presidio di Passirana

    Passirana Di Rho, 20017

  • Ospedale Fondazione Salvatore Maugeri

    Pavia, 27100

  • Ospedale Sant´ Antonio

    San Daniele, 33038

  • Ospedale San Bartolomeo

    Sarzana, 19038

  • Presidio Ospedaliero di Sondrio

    Sondrio, 23100

  • Casa di Cura - Villa Bianca

    Trento, 38100

Other trials in Italy

Brazil5 sites

  • INOVAR Pesquisas clínicas

    São Paulo, 04012-060

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

    São Paulo, 04012-180

  • Nefrología Centro de Pesquisa Clínica do Hospital do Rim e Hipertensão

    São Paulo, 04025-011

  • UNIFESP - Setor de Lípides, Atersclerose e Biologia Vascular

    São Paulo, 04039-030

  • Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo

Other trials in Brazil

Paraguay4 sites

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

    Asunción

  • Hospital Universitario Nuestra Señora de la Asunción

    Asunción

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

    Asunción

  • Hospital Nacional de Itagua

    Itauguá

Other trials in Paraguay

About this study

Official title: Improving Equitable Acces and Adherence to Secondary Prevention Therapy With a Fixed-Dose Combination Drug

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.

Read the 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.
Being tested
FDC, Separately drugs, simvastatin, aspirin and ramipril
Keywords
Myocardial Infarction, Treatment Adherence
Medical subject headings
Myocardial Infarction, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FDCDrug

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

  • Separately drugs, simvastatin, aspirin and ramiprilDrug

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

Study groups in NCT01321255
Study groupRoleWhat they receive
FDC Fixed Dose CombinationExperimentalNot described
Receives: Drug: FDC
Conventional treatmentActive comparatorNot described
Receives: Drug: Separately drugs, simvastatin, aspirin and ramipril

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 18 months

  2. 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

    Measured: 18 months

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

    Phase 2

    Measured: 18 months

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

    Phase 2

    Measured: 18 months

Secondary outcomes (2)

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

    Phase 2

    Measured: 18 months

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

    Phase 2

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionMay 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01321255
Sponsor's protocol ID
FOCUS
Other IDs
2010-022492-54, Health-F2-2009-241559
Acronym
FOCUS
Status last verified
Jul 2014
First submitted
21 Mar 2011
Last updated
15 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • World Health Organization. Price, availability and affordability. An international comparison of chronic disease medicines. Background report prepared for the WHO Plannig Meeting on the Global Initiative for Treatment of Chronic Diseases, Cairo, December 2005

  • European Cardiovascular Disease Statistics. British Heart Foundation and European Heart Network. 2005

  • European Health Heart Charter. Available at www.heartcharter.eu

  • Beaglehole R, Reddy S, Leeder SR. Poverty and human development: the global implications of cardiovascular disease. Circulation. 2007 Oct 23;116(17):1871-3. doi: 10.1161/CIRCULATIONAHA.107.736926. No abstract available.

    PubMed 17965400

  • kaplan W. LR. Priority medicines for Europe and the World; 2004 November.

  • Reddy KS. Cardiovascular diseases in the developing countries: dimensions, determinants, dynamics and directions for public health action. Public Health Nutr. 2002 Feb;5(1A):231-7. doi: 10.1079/phn2001298.

    PubMed 12027289

  • Ezzati M, Lopez AD. Estimates of global mortality attributable to smoking in 2000. Lancet. 2003 Sep 13;362(9387):847-52. doi: 10.1016/S0140-6736(03)14338-3.

    PubMed 13678970

  • Mackenbach JP, Stirbu I, Roskam AJ, Schaap MM, Menvielle G, Leinsalu M, Kunst AE; European Union Working Group on Socioeconomic Inequalities in Health. Socioeconomic inequalities in health in 22 European countries. N Engl J Med. 2008 Jun 5;358(23):2468-81. doi: 10.1056/NEJMsa0707519.

    PubMed 18525043

  • Asaria P, Chisholm D, Mathers C, Ezzati M, Beaglehole R. Chronic disease prevention: health effects and financial costs of strategies to reduce salt intake and control tobacco use. Lancet. 2007 Dec 15;370(9604):2044-53. doi: 10.1016/S0140-6736(07)61698-5. Epub 2007 Dec 11.

    PubMed 18063027

  • Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.

    PubMed 15364185

  • Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. Lancet. 2006 May 27;367(9524):1747-57. doi: 10.1016/S0140-6736(06)68770-9.

    PubMed 16731270

  • Sanz GA. [Risk stratification in acute coronary syndromes: an unresolved issue]. Rev Esp Cardiol. 2007 Oct;60 Suppl 3:23-30. Spanish.

    PubMed 18093491

  • Granger CB, Goldberg RJ, Dabbous O, Pieper KS, Eagle KA, Cannon CP, Van De Werf F, Avezum A, Goodman SG, Flather MD, Fox KA; Global Registry of Acute Coronary Events Investigators. Predictors of hospital mortality in the global registry of acute coronary events. Arch Intern Med. 2003 Oct 27;163(19):2345-53. doi: 10.1001/archinte.163.19.2345.

    PubMed 14581255

  • Chiuve SE, McCullough ML, Sacks FM, Rimm EB. Healthy lifestyle factors in the primary prevention of coronary heart disease among men: benefits among users and nonusers of lipid-lowering and antihypertensive medications. Circulation. 2006 Jul 11;114(2):160-7. doi: 10.1161/CIRCULATIONAHA.106.621417. Epub 2006 Jul 3.

    PubMed 16818808

  • Davies AR, Smeeth L, Grundy EM. Contribution of changes in incidence and mortality to trends in the prevalence of coronary heart disease in the UK: 1996 2005. Eur Heart J. 2007 Sep;28(17):2142-7. doi: 10.1093/eurheartj/ehm272. Epub 2007 Jul 18.

    PubMed 17636307

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FDC and Separately drugs, simvastatin, aspirin and ramipril in people with Myocardial Infarction, run by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III at 69 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in Argentina, Spain, Italy, Brazil, Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01321255, which also lists 63 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.

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