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IRCT20180507039571N2 IRCT 2020-12-19 National Institute for Medical Research Development (nimad) Efficacy of polypill in secondary prevention of cardiovascular disease in patients with a history of acute coronary syndrome 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 2019-05-20 anticipated 1200 Complete https://irct.ir/trial/52313 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization with permuted blocks of 2, 4, 6, or 8 will be used and random sequence will be generated by "Random allocation software" to equally distribute Participants in two arms. An investigator will be responsible for central Randomization and recording the list of patients. Responsible physicians in The hospitals will assess patients for eligibility criteria and after getting Informed consent, they will contact the investigator for the type of intervention Allocation. Blinding of investigators and patients is not possible in this study, However, statistician will be blind to the group assignment. 3 Acute myocardial infarction. 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 Alborz Daroo Co., prescribed once daily by moth for 34 mounths. Intervention 2: Control group: receive regular drug order at the time of discharge from the hospital including aspirin, atorvastatin, a beta blocker, and an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Shervin Ghaffari Hoseini
No 19, Afiat Street, Ferdosi
Isfahan Iran (Islamic Republic of) 8143846431 +98 31 3222 5417 shghaffari@yahoo.com Esfahan University of Medical Sciences scientific Masoumeh Sadeghi
No 90, No 7 Ave, Ammar Ave, Mardavij Str
Isfahan Iran (Islamic Republic of) 8168947493 +98 31 3611 5208 sadeghimasoumeh@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 40 years no limit Both 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). I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Treatment - Drugs 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 Alborz Daroo Co., prescribed once daily by moth for 34 mounths. Control group: receive regular drug order at the time of discharge from the hospital including aspirin, atorvastatin, a beta blocker, and an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker 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. 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. NCT03541109 مرکز ثبت کارآزمائي هاي باليني ايالات متحده آمريکا National Institute for Medical Research Development (nimad) Approved 2017-12-15 Ethics committee of national institute for medical research development (nimad) No 21, Besat Ave, West Fatemi Ave, Tehran Tehran Tehran Iran (Islamic Republic of)