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

Myocardial Infarction Clinical Trial

— FOCUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321255
• Other study ID #: FOCUS
• Secondary ID: 2010-022492-54He
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2011
• Last updated: July 14, 2014
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2118
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Argentina	CENUDIAB	Buenos Aires
Argentina	Sanatorio Güemes	Buenos Aires
Argentina	Centro Médico GEA 3 Privado	Córdoba
Argentina	Clínica Colombo	Córdoba
Argentina	Hospital de Córdoba	Córdoba
Argentina	Hospital Italiano	Córdoba
Argentina	Hospital Nuestra Señora de la Misericordia	Córdoba
Argentina	Hospital San Roque	Córdoba
Argentina	Instituto Médico DAMIC	Córdoba
Argentina	IPAC - Clínica Privada Caraffa S.R.L.	Córdoba
Argentina	Sanatorio Parque S.A.	Córdoba
Argentina	Consultan Salud S.A.	Haedo
Argentina	Fundación CICLO	La Plata
Argentina	Hospital Italiano	La Plata
Argentina	Clínica Constituyentes	Morón
Argentina	Instituto de Investigaciones Clínicas Quilmes	Quilmes
Argentina	DIM Clínica Privada	Ramos Mejía
Argentina	Hospital Italiano de Rosario Garibaldi	Rosario
Argentina	Hospital Provincial del Centenario	Rosario
Argentina	Sanatorio Británico S.A.	Rosario
Argentina	Sanatorio Julio Corzo	Rosario
Argentina	Corporación Médica General San Martín	San Martín
Argentina	Clínica Privada de la Ciudad S.R.L.	Villa Allende
Argentina	Clínica Privada de Especialidades de Villa María S.R.L.	Villa María
Argentina	Sanatorio Cruz Azul S.R.L.	Villa María
Brazil	Centro de Pesquisa SeÇão de Hipeertensão e Nefrología - Instituto Dante Pazzanese	Sao Paulo
Brazil	Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo
Brazil	INOVAR Pesquisas clínicas	Sao Paulo
Brazil	Nefrología Centro de Pesquisa Clínica do Hospital do Rim e Hipertensão	Sao Paulo
Brazil	UNIFESP - Setor de Lípides, Atersclerose e Biologia Vascular	Sao Paulo
Italy	Ospedale F. Ferrari	Casarano
Italy	Azienda Istituti Ospitalieri	Cremona
Italy	Presidio Ospedaliero di Desio	Desio
Italy	Ospedale S. Cuore di Gesù	Gallipoli
Italy	Ospedale F. Veneziale	Isernia
Italy	Ospedale Niguarda Cá Granda	Milano
Italy	Azienda Ospedaler San Gerardo	Monza
Italy	Ospedale Civile San Francesco di Paola	Paola
Italy	Azienda Ospedale G. Salvani - Presidio di Passirana	Passirana di Rho
Italy	Ospedale Fondazione Salvatore Maugeri	Pavia
Italy	Ospedale Sant´ Antonio	San Daniele
Italy	Ospedale San Bartolomeo	Sarzana
Italy	Presidio Ospedaliero di Sondrio	Sondrio
Italy	Casa di Cura - Villa Bianca	Trento
Paraguay	Hospital Central del Instituto de Previsión Social (HC-IPS)	Asunción
Paraguay	Hospital Universitario Nuestra Señora de la Asunción	Asunción
Paraguay	Hospitalñ de Clínicas - Catedra de Semiologia Médica - Universidad Nacional de Asunción	Asunción
Paraguay	Hospital Nacional de Itagua	Itaugua
Spain	Hospital Principes de Asturias	Alcalá de Henares	Madrid
Spain	CS Aldaia	Aldaya	Valencia
Spain	Hospital General de Alicante	Alicante
Spain	ABS Gaudi	Barcelona
Spain	CAP Vallcarca	Barcelona
Spain	EAP Poble Sec	Barcelona
Spain	EAP Sardenya	Barcelona
Spain	EAP Sarrià	Barcelona
Spain	Hospital Clinic	Barcelona
Spain	Hospital Sant Pau	Barcelona
Spain	CS Cheste	Cheste	Valencia
Spain	CS Ángela Uriarte	Madrid
Spain	CS San Andrés III	Madrid
Spain	CS Villablanca	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital La Princesa	Madrid
Spain	Hospital Puerta de Hierro	Majadahonda	Madrid
Spain	CS Manises	Manises	Valencia
Spain	Hospital Virgen Arrixaca	Murcia
Spain	CS Ribarroja del Túria	Ribarroja	Valencia
Spain	Hospital Virgen Macarena	Sevilla

Sponsors (9)

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

Countries where clinical trial is conducted

Argentina,  Brazil,  Italy,  Paraguay,  Spain, 

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* Note: There are 61 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months.	Phase 2	18 months	No
Primary	Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC)	Phase 2	18 months	No
Secondary	Blood Pressure and Lipid Profile (LDL-cholesterol) at 1 and 9 months	Phase 2	18 months	No
Secondary	Safety and tolerability: Adverse events and rate of treatment withdrawal.	Phase 2	18 months	Yes

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