Fixed Dose Combination Drug (Polypill)for Secondary Cardiovascular Prevention. (FOCUS)
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|ClinicalTrials.gov Identifier: NCT01321255|
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : July 15, 2014
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|
The specific objective of the FOCUS project is to prove that:
- 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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Equitable Acces and Adherence to Secondary Prevention Therapy With a Fixed-Dose Combination Drug|
|Study Start Date :||January 2012|
|Primary Completion Date :||May 2014|
|Study Completion Date :||June 2014|
|Experimental: FDC Fixed Dose Combination||
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
- 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 ]Phase 1
- Adherence to treatment measured by the Morisky-Green questionnaire [ Time Frame: 18 months ]
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 ]Phase 2
- Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) [ Time Frame: 18 months ]Phase 2
- Blood Pressure and Lipid Profile (LDL-cholesterol) at 1 and 9 months [ Time Frame: 18 months ]Phase 2
- Safety and tolerability: Adverse events and rate of treatment withdrawal. [ Time Frame: 18 months ]Phase 2
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321255
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|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|