Fixed Dose Combination Drug (Polypill)for Secondary Cardiovascular Prevention. (FOCUS)
This study is currently recruiting participants.
Verified February 2013 by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Sponsor:
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
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: February 12, 2013
Last verified: February 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction |
Drug: FDC Drug: Separately drugs, simvastatin, aspirin and ramipril |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Improving Equitable Acces and Adherence to Secondary Prevention Therapy With a Fixed-Dose Combination Drug |
Resource links provided by NLM:
Further study details as provided by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 4000 |
| Study Start Date: | January 2012 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: FDC Fixed Dose Combination |
Drug: FDC
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321255
Show 86 Study Locations
Contacts
| Contact: Ginés Sanz, MD PhD | +34 914531200 | gsanz@cnic.es |
| Contact: Luz Alvarez, Bch | +34914531200 ext 4109 | lalvarez@cnic.es |
Show 86 Study LocationsSponsors and Collaborators
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.
Investigators
| 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 |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III |
| ClinicalTrials.gov Identifier: | NCT01321255 History of Changes |
| Other Study ID Numbers: | FOCUS, 2010-022492-54, Health-F2-2009-241559 |
| Study First Received: | March 21, 2011 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III:
|
Myocardial Infarction Treatment Adherence |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Aspirin Ramipril Simvastatin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013