A Polypill for Secondary Prevention of Ischemic Heart Disease

Isfahan University of Medical Sciences1,200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,200

Conditions

Acute Myocardial Infarction ST Elevation Myocardial Infarction Non-ST Elevation Myocardial Infarction

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: from time of randomization up to 34 months

Secondary Outcomes

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.

Time frame: up to 34 months

Central Contacts

Masoumeh Sadeghi, Professor

CONTACT

00989134091776 sadeghimasoumeh@gmail.com

Shervin Ghaffari Hoseini, MD,PhD