Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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.


Options:
A: Inclusion Criteria:

* Age between 45 and 80 years
* At least any one of the following CVD risk factors:

  * Stable type 2 diabetes mellitus or
  * Hypertension or
  * Current smoker or
  * A waist to hip ratio \> 0.85 for women and \>0.9 for men or
  * Elevated lipids.
* Informed consent.

Exclusion Criteria:

* On any of the study medications,
* Uncontrolled blood pressure,
* Symptomatic hypotension,
* Any clear indication or a contraindication to the use of any of the study medications,
* History of coronary/cerebrovascular events,
* Pregnancy or lactating or women of child-bearing potential with inadequate contraception and / or an inability to attend follow up visits.
B: 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.
C: Inclusion Criteria:

* The participant is able to give informed consent.
* The trial Investigator considers that each of the polypill components are indicated at the doses in the Red Heart Pill
* Established atherothrombotic cardiovascular disease (CVD) or intermediate to high cardiovascular risk, defined as;

  * History of coronary heart disease (myocardial infarction, stable or unstable angina pectoris, or coronary revascularisation procedure), or
  * History of ischaemic cerebrovascular disease (ischaemic stroke or transient ischaemic attack), or
  * History of peripheral vascular disease (peripheral revascularisation procedure or amputation due to vascular disease or aortic reconstruction), or
  * For individuals without established cardiovascular disease, a calculated 5 year CVD risk of 5% or greater (calculated using the 1991 Anderson Framingham risk equation with adjustments as defined by the New Zealand Guidelines Group recommendations - (Appendix 1))

Exclusion Criteria:

* Contraindication to any of the components of the polypill (e.g. known intolerance to aspirin, statins, or ACE inhibitors; pregnancy or likely to become pregnant or breastfeeding women during the treatment period). Such contraindications are fully listed in the Investigator Brochures.
* The treating doctor considers that changing a participant's cardiovascular medications would put the participant at risk (e.g. symptomatic heart failure, high dose β-blocker required to manage angina or for rate control in atrial fibrillation, accelerated hypertension, severe renal insufficiency, a history of severe resistant hypertension).
* Other potential reasons for exclusion include:
* Known situation where medication regimen might be altered for a significant length of time, e.g. current acute cardiovascular event, planned coronary bypass graft operation.
* Unlikely to complete the trial (e.g. life-threatening condition other than cardiovascular disease) or adhere to the trial procedures or attend study visits (e.g. major psychiatric condition, dementia).
* Any reason, medical condition, ongoing medication or significant disability that would prevent the participant complying with trial consent, treatment and follow-up procedures or potentially jeopardise her / his medical care.
* Night shift workers.
D: Inclusion Criteria:

* Estimated 10-year total CVD risk score \> 20%. The total CVD risk assessment will be based on the recently developed WHO CVD risk prediction charts
* No contraindication for treatment with aspirin, angiotensin converting enzyme inhibitors, low-dose diuretics, or statins
* Informed consent given

Exclusion Criteria:

* Patients with established angina pectoris, coronary heart disease, myocardial infarction, transient ischemic attacks, stroke, peripheral vascular disease, coronary revascularization and/or carotid endarterectomy Left ventricular hypertrophy (on ECG) or hypertensive retinopathy (grade III or IV)
* Patients with secondary hypertension
* Patients with diabetes type 1 or 2 with overt neuropathy or other significant renal disease.
* Known renal failure or impairment
* Atrial fibrillation
* ALT \> 1.5 times the upper limit of normal
* History of liver cirrhosis or hepatitis
* History of recent gastrointestinal bleeding (within the last year)
* Women in child bearing period
* History of life-limiting diseases or events
* Unwillingness to sign informed consent.

Answer: B