A Polypill for Secondary Prevention of Ischemic Heart Disease

  • STATUS
    Recruiting
  • End date
    Aug 26, 2024
  • participants needed
    1200
  • sponsor
    Isfahan University of Medical Sciences
Updated on 26 January 2021
aspirin
atorvastatin
heart failure
heart disease
stemi
bypass graft
beta blockers
hmg-coa reductase inhibitor
metoprolol
ace inhibitor
acute coronary syndrome
secondary prevention
beta-adrenergic blocking agents
acute myocardial infarction
valsartan
hmg-coa reductase inhibitors

Summary

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.

Details
Condition Myocardial Infarction, Heart Attack (Myocardial Infarction), Heart Attack (Myocardial Infarction), STEMI, Acute Myocardial Infarction, Non-ST-elevation Myocardial Infarction, ST Elevation Myocardial Infarction
Treatment PolyPill
Clinical Study IdentifierNCT03541109
SponsorIsfahan University of Medical Sciences
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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