Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fixed Dose Combination Drug (Polypill)for Secondary Cardiovascular Prevention. (FOCUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01321255
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : July 15, 2014
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE March 21, 2011
First Posted Date  ICMJE March 23, 2011
Last Update Posted Date July 15, 2014
Study Start Date  ICMJE January 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2011)
  • 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 ]
    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 ]
    Phase 2
  • Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) [ Time Frame: 18 months ]
    Phase 2
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01321255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fixed Dose Combination Drug (Polypill)for Secondary Cardiovascular Prevention.
Official Title  ICMJE Improving Equitable Acces and Adherence to Secondary Prevention Therapy With a Fixed-Dose Combination Drug
Brief 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.

Detailed Description

The specific objective of the FOCUS project is to prove that:

  1. 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.
  2. 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • Drug: FDC
    FDC includes a combination of 100 mg aspirin, 40 mg simvastatin, and 2.5;5;10 mg Ramipril
  • 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
Study Arms  ICMJE
  • Experimental: FDC Fixed Dose Combination
    Intervention: Drug: FDC
  • Active Comparator: Conventional treatment
    Intervention: Drug: Separately drugs, simvastatin, aspirin and ramipril
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2014)
2118
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2011)
4000
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Italy,   Paraguay,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01321255
Other Study ID Numbers  ICMJE FOCUS
2010-022492-54 ( EudraCT Number )
Health-F2-2009-241559 ( Other Grant/Funding Number: Frame of Seventh Investigation Marco Programme, Technological development and Innovation of the EU )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Study Sponsor  ICMJE Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP