Acute myocardial infarction. ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Conditions
Interventions
Intervention 1: Intervention group: receive polypill-s tablet which is fixed dose combination of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg) and is prepared by Albo
Sponsors
National Institute for Medical Research Development (nimad)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score of composite clinical outcome (major adverse cardiovascular events (MACE)) including cardiac death, fatal/nonfatal MI or stroke, hospitalization due to acute coronary syndrome/acute cerebrovascular accident, revascularization procedures, development or worsening of HF, and development of persistent new AF. Timepoint: From time of randomization up to 34 months after beginning of the intervention. Method of measurement: Incidence of clinical adverse events will be asked from the patient or relatives and will be confirmed by patient’s medical records. HF will be assessed by echocardiography which will be done at the beginning and at the last follow-up and during the study if indicated by patient symptoms or physical examination. Persistent new AF will be documented by electrocardiograms recorded at the first and last follow-up and as needed if related new signs or symptoms develop during the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost-effectiveness of Polypill treatment compared with usual care. Timepoint: From time of randomization up to 34 months after beginning of the intervention. Method of measurement: Medical costs including healthcare visits, laboratory tests, imaging procedures, drugs, hospital admissions and procedures will be collected at each follow-up and polypill costs will be added.;Drug related adverse events resulting from polypill or routine cardiac drugs, including hypotension, gastric irritation, dyspepsia, bleeding, myalgia, elevated liver enzymes, renal dysfunction, and drug allergies. Timepoint: 1, 4, 10, 22, and 34 months after beginning of the intervention. Method of measurement: A questionnaire filled by the responsible physician (by history and physical examination).;Scores of health related quality of life (HRQL). Timepoint: Before intervention and 1, 4, 10, 22, and 34 months after beginning of the intervention. Method of measurement: Persian version of the 12-Item Short Form Health Survey (SF-12).;Scores of self-reported patient adherence to the medication(s). Timepoint: 1, 4, 10, 22, and 34 months after beginning of the intervention. Method of measurement: Persian version of 8-Item Morisky Medication Adherence Scale (MMAS-8).;Mean of systolic and diastolic blood pressure. Timepoint: Before intervention and 1, 4, 10, 22, and 34 months after beginning of the intervention. Method of measurement: Average readings of systolic blood pressure measured two times (at least 3 min apart) at sitting position by digital sphygmomanometer.;Serum level of total cholestrole. Timepoint: Before intervention and 1, 4, 10, 22, and 34 months after beginning of the intervention. Method of measurement: With cholesterol oxidase method by autoanalyzer. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShervin Ghaffari Hoseini
Esfahan University of Medical Sciences
Outcome results
None listed