Adherence to and cost-effectiveness of polypill versus usual care for secondary prevention of cardiovascular diseases in patients with a history of acute coronary syndrome, a randomized clinical trial

Inclusion criteria:

Age over 40 years Patients hospitalized because of an acute myocardial infarction (STEMI/NSTEMI) and alive after discharge for at least 1 month Signing informed consent Clear indication of receiving all components of Polypill (aspirin, statin, ACE inhibitor/ARB, and beta blocker) Living in Isfahan city or nearby areas so that they can attend follow-ups No mental illness limiting their self-care ability or Severe illness with an estimated lifespan of less than 3 years No history of adverse reaction or contraindication to any component of the Polypill Not having Secondary hyperlipidemia, serum creatinine ≥ 2, severe heart failure No plan for a procedure (CABG, PCI, or another surgical procedures) within following 6 months

Exclusion criteria:

Contraindication to any component of the polypill History of adverse reaction to any component of the polypill Mental illness limiting self-care ability Severe illness with an estimated lifespan of less than 3 years Systolic blood pressure < 90 mm Hg or diastolic blood pressure < 60 mm Hg Familial hyperlipidemias Bradycardia (less than 50 beat/min) Sick sinus syndrome (unless patient has a permanent pacemaker) AV heart block (except for first degree) Serum creatinine ≥ 2 or glomerular filtration rate < 30 mL/min Chronic liver failure Severe heart failure (NYHA class III, IV) Planning for a procedure (CABG, PCI, or another surgical procedures) within following 6 months Pregnant or lactating women Participation in another trial Patient’s unwilling to complete the trial Need to change or discontinue any of the four principal drugs of the Polypill to achieve better control of the disease or risk factors or because of adverse drug reactions (based on physician's idea).

Target sample size: 1200