Fixed Dose Combination Drug (FDC) for Secondary Cardiovascular Prevention. Improving equitable access and adherence to secondary Prevention therapy with a Fixed-Dose Combination Drug - FOCUS

Conditions: Secondary prevention of mycordial infarction
MedDRA version: 9.1Level: LLTClassification code 10048858

Registration Number: EUCTR2010-022492-54-IT

Lead Sponsor: Centro Nacional de Investigaciones Cardiovasculares (CNIC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1340

Inclusion Criteria

All patients, male and female, 40 years of age or older, with a history of ST-elevation MI within the last 2 years, attending any of the selected sites and signing the consent Patients in whom secondary prevention with aspirin, statin and ACE-inhibitors is indicated.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with: secondary dyslipemia; in which any of the components of the FDC is contraindicated; living in a nursing home or with mental illness limiting the capacity of self care or participating in another trial; with previous percutaneous transluminal coronary angioplasty (PTCA) with a drug eluting stent (DES) whitin the last year; with severe congestive heart failure (NYHA III-IV); with serum creatinine >2 mg/dl; with any condition limiting life expectancy (<2years); pregnant or premenopausal women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare adherence to treatment in post MI (myocardial infarction) patients receiving a FDC including aspirin, ramipril, and simvastatin vs those with conventional treatment (3 drugs provided separately).;Primary end point(s): Treatment adherence measured by: Morisky-Green test at 1 and 9 months. Pill counts at 1-4-9 months.;Secondary Objective: To evaluate the effect of a FDC including aspirin, ramipril, and simvastatin on blood pressure control and lipid profile in patients with a previous myocardial infarction as compare with conventional treatment (3 drugs provided separately). To assess the safety and tolerability of the FDC treatment, and to analyze cost utility of FDC in comparison with conventional treatment

Secondary Outcome Measures