CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,118 enrolled
Drug / intervention
FDC +1 moredrug
Likely dose
FDC 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01321255
NCT01321255Phase 3Completed

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

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III·interventional·Posted Mar 23, 2011·Updated Jul 15, 2014

In Brief

A Phase 3 clinical trial evaluating FDC and Separately drugs, simvastatin, aspirin and ramipril for Myocardial Infarction. Completed, enrolled 2,118 participants across 69 sites in 5 countries.

Detailed 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.

Study Details

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2011
Enrollment StartJan 1, 2012
Primary CompletionMay 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.3 years ago

Interventions

FDCdrug

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

Separately drugs, simvastatin, aspirin and ramiprildrug

Aspirin 100 mg once a day Ramipril 2.5; 5; 10 mg once a day Simvastatin 40 mg once a day