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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

March 21, 2011
July 14, 2014
January 2012
May 2014   (final data collection date for 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 ] [ 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
Same as current
Complete list of historical versions of study NCT01321255 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Fixed Dose Combination Drug (Polypill)for Secondary Cardiovascular Prevention.
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Myocardial Infarction
  • Drug: FDC
    FDC includes a combination of 100 mg aspirin, 40 mg simvastatin, and 2.5;5;10 mg Ramipril
  • 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
  • Experimental: FDC Fixed Dose Combination
    Intervention: Drug: FDC
  • Active Comparator: Conventional treatment
    Intervention: Drug: Separately drugs, simvastatin, aspirin and ramipril

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2118
June 2014
May 2014   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Italy,   Paraguay,   Spain
 
NCT01321255
FOCUS, 2010-022492-54, Health-F2-2009-241559
Yes
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
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.
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
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP