A Polypill for Secondary Prevention of Ischemic Heart Disease

Isfahan University of Medical Sciences

Status and phase: Enrolling; Phase 3

Conditions: ST Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction; Acute Myocardial Infarction

Treatments: Drug: Polypill

Study type: Interventional

Funder types: Other

Identifiers

NCT03541109

Persian Polypill

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,200 participants in 2 patient groups

Polypill

Experimental group

Description:

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

Treatment:

Drug: Polypill

Control

No Intervention group

Description:

The usual care arm will receive regular drug order at the time of discharge from the hospital.