Myocardial Infarction | Fixed Dose Combination Drug (Polypill)for Secondary Cardiovascular Prevention.
Myocardial Infarction research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:FDCFDC includes a combination of 100 mg aspirin, 40 mg simvastatin, and 2.5;5;10 mg Ramipril
Drug:Separately drugs, simvastatin, aspirin and ramiprilAspirin 100 mg once a day Ramipril 2.5; 5; 10 mg once a day Simvastatin 40 mg once a day
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
FDC Fixed Dose Combination
Start Date: January 2012
Completed Date: June 2014
Phase: Phase 3
Primary Outcome: 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.
Secondary Outcome: Blood Pressure and Lipid Profile (LDL-cholesterol) at 1 and 9 months
Study sponsors, principal investigator, and references
Principal Investigator: Valentín Fuster, MD PhD
Lead Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Collaborator: Mario Negri Institute for Pharmacological Research
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