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

• Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III (Other)
• Overall Status: Completed
• CT.gov ID: NCT01321255
• Collaborator: Mario Negri Institute for Pharmacological Research (Other), Rusculleda Foundation Instituto DAMIC (Other), Fundacion Clinic per a la Recerca Biomédica (Other), ARTTIC International Management Services (Other), Federación Argentina de Cardiología FAC (Other), World Health Organization (Other), Instituto de Salud Carlos III (Other), Ferrer Internacional S.A. (Industry)
• Enrollment: 2,118
• Locations: 69
• Arms: 2
• Duration (Months): 29
• Patients Per Site: 30.7
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Drug: FDC; Drug: Separately drugs, simvastatin, aspirin and ramipril	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Improving Equitable Acces and Adherence to Secondary Prevention Therapy With a Fixed-Dose Combination Drug
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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. [18 months]

   Phase 1

2. Adherence to treatment measured by the Morisky-Green questionnaire [18 months]

   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

3. Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months. [18 months]

   Phase 2

4. Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) [18 months]

   Phase 2

Secondary Outcome Measures

1. Blood Pressure and Lipid Profile (LDL-cholesterol) at 1 and 9 months [18 months]

   Phase 2

2. Safety and tolerability: Adverse events and rate of treatment withdrawal. [18 months]

   Phase 2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Sanatorio Güemes	Buenos Aires		Argentina	C1180AAX
2	CENUDIAB	Buenos Aires		Argentina	C1440AAD
3	Centro Médico GEA 3 Privado	Córdoba		Argentina	X5000BSQ
4	Hospital San Roque	Córdoba		Argentina	X5000EPU
5	Hospital Nuestra Señora de la Misericordia	Córdoba		Argentina	X5000JRD
6	Clínica Colombo	Córdoba		Argentina	X5002AOQ
7	Instituto Médico DAMIC	Córdoba		Argentina	X5003DCE
8	Hospital Italiano	Córdoba		Argentina	X5004BAL
9	Hospital de Córdoba	Córdoba		Argentina	X5004COT
10	Sanatorio Parque S.A.	Córdoba		Argentina	X5006IKK
11	IPAC - Clínica Privada Caraffa S.R.L.	Córdoba		Argentina	X5008KKF
12	Consultan Salud S.A.	Haedo		Argentina	B1706AJU
13	Hospital Italiano	La Plata		Argentina	B1900AXI
14	Fundación CICLO	La Plata		Argentina	B1902AGY
15	Clínica Constituyentes	Morón		Argentina	B1708KCH
16	Instituto de Investigaciones Clínicas Quilmes	Quilmes		Argentina	B1878GEG
17	DIM Clínica Privada	Ramos Mejía		Argentina	B1704ETD
18	Sanatorio Británico S.A.	Rosario		Argentina	S2000CVB
19	Hospital Italiano de Rosario Garibaldi	Rosario		Argentina	S2001ODA
20	Hospital Provincial del Centenario	Rosario		Argentina	S2002KDS
21	Sanatorio Julio Corzo	Rosario		Argentina	S2002OUR
22	Corporación Médica General San Martín	San Martín		Argentina	B1650CSQ
23	Clínica Privada de la Ciudad S.R.L.	Villa Allende		Argentina	X5105EQH
24	Sanatorio Cruz Azul S.R.L.	Villa María		Argentina	X5900EBG
25	Clínica Privada de Especialidades de Villa María S.R.L.	Villa María		Argentina	X5901ACG
26	INOVAR Pesquisas clínicas	Sao Paulo		Brazil	04012-060
27	Centro de Pesquisa SeÇão de Hipeertensão e Nefrología - Instituto Dante Pazzanese	Sao Paulo		Brazil	04012-180
28	Nefrología Centro de Pesquisa Clínica do Hospital do Rim e Hipertensão	Sao Paulo		Brazil	04025-011
29	UNIFESP - Setor de Lípides, Atersclerose e Biologia Vascular	Sao Paulo		Brazil	04039-030
30	Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo		Brazil
31	Ospedale F. Ferrari	Casarano		Italy	73042
32	Azienda Istituti Ospitalieri	Cremona		Italy	26100
33	Presidio Ospedaliero di Desio	Desio		Italy	20832
34	Ospedale S. Cuore di Gesù	Gallipoli		Italy	73014
35	Ospedale F. Veneziale	Isernia		Italy	86170
36	Ospedale Niguarda Cá Granda	Milano		Italy	20159
37	Azienda Ospedaler San Gerardo	Monza		Italy	20900
38	Ospedale Civile San Francesco di Paola	Paola		Italy	87027
39	Azienda Ospedale G. Salvani - Presidio di Passirana	Passirana di Rho		Italy	20017
40	Ospedale Fondazione Salvatore Maugeri	Pavia		Italy	27100
41	Ospedale Sant´ Antonio	San Daniele		Italy	33038
42	Ospedale San Bartolomeo	Sarzana		Italy	19038
43	Presidio Ospedaliero di Sondrio	Sondrio		Italy	23100
44	Casa di Cura - Villa Bianca	Trento		Italy	38100
45	Hospital Central del Instituto de Previsión Social (HC-IPS)	Asunción		Paraguay
46	Hospital Universitario Nuestra Señora de la Asunción	Asunción		Paraguay
47	Hospitalñ de Clínicas - Catedra de Semiologia Médica - Universidad Nacional de Asunción	Asunción		Paraguay
48	Hospital Nacional de Itagua	Itaugua		Paraguay
49	Hospital Principes de Asturias	Alcalá de Henares	Madrid	Spain	28802
50	Hospital Puerta de Hierro	Majadahonda	Madrid	Spain	28222
51	CS Aldaia	Aldaya	Valencia	Spain	46960
52	CS Cheste	Cheste	Valencia	Spain	46380
53	CS Manises	Manises	Valencia	Spain	46940
54	CS Ribarroja del Túria	Ribarroja	Valencia	Spain	46190
55	Hospital General de Alicante	Alicante		Spain	03010
56	EAP Poble Sec	Barcelona		Spain	08004
57	CAP Vallcarca	Barcelona		Spain	08023
58	ABS Gaudi	Barcelona		Spain	08025
59	EAP Sardenya	Barcelona		Spain	08025
60	Hospital Sant Pau	Barcelona		Spain	08025
61	EAP Sarrià	Barcelona		Spain	08034
62	Hospital Clinic	Barcelona		Spain	08036
63	Hospital La Princesa	Madrid		Spain	28006
64	CS Ángela Uriarte	Madrid		Spain	28018
65	CS San Andrés III	Madrid		Spain	28021
66	CS Villablanca	Madrid		Spain	28032
67	Hospital Clinico San Carlos	Madrid		Spain	28040
68	Hospital Virgen Arrixaca	Murcia		Spain	30120
69	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• CNIC

Publications

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• Responsible Party: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
• ClinicalTrials.gov Identifier: NCT01321255
• Other Study ID Numbers: FOCUS; 2010-022492-54; Health-F2-2009-241559
• First Posted: Mar 23, 2011
• Last Update Posted: Jul 15, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III: Myocardial Infarction; Treatment Adherence
• Additional relevant MeSH terms: Myocardial Infarction; Infarction; Aspirin; Ramipril; Simvastatin

Study Results

No Results Posted as of Jul 15, 2014