A Polypill for Secondary Prevention of Ischemic Heart Disease

Study Overview
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Brief Summary
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Cardiovascular diseases (CVD) are the leading cause of mortality and morbidity worldwide. The most important aspect of CVD secondary prevention is adherence to guideline-indicated pharmacological therapy which globally remains low. In previous studies, a Polypill containing fixed dose combination of essential drugs have improved patient adherence to these drugs. The effect of such a strategy on pharmacological therapy uptake, cost-effectiveness, and CVD recurrence in our setting will be assessed in this study. Participants hospitalized in three referral hospitals in Isfahan, Iran because of an acute myocardial infarction (MI) (ST elevation MI (STEMI) or non-ST elevation MI (NSTEMI)) will be randomized to either receiving Polypill or usual care after MI. Patient recruitment will be carried out at the time of patient discharge from the hospitals.

Official Title
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Fixed Combination Therapy for Secondary Prevention of Major Cardiovascular Events

Conditions
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Acute Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Polypill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: Patient unlikely to complete 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) Severe illness with an estimated lifespan of less than 3 years

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polypill<br>Polypill group will receive a fixed dose combinations of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg), prescribed once daily by moth for 34 months | Drug: Polypill<br>* fixed dose combination of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg)<br>* Other names: Polypill-S;|
| No Intervention: Control<br>The usual care arm will receive regular drug order at the time of discharge from the hospital. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite clinical outcome of major adverse cardiovascular events (MACE) | MACE includes 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. | from time of randomization up to 34 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost-effectiveness of Polypill treatment compared with usual care | The analysis will be done on direct and indirect costs of treatment. Direct costs will be assessed from perspective of health care system. Current Iranian public medical tariffs will be the base of calculations. The incremental cost effectiveness ratio (ICER) will be calculated for primary outcomes. | up to 34 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular disease, fixed dose combination therapy, cost effectiveness