A Polypill for Secondary Prevention of Ischemic Heart Disease

Phase 3

• Conditions: Non-ST Elevation Myocardial Infarction; Acute Myocardial Infarction; ST Elevation Myocardial Infarction
• Interventions: Drug: Polypill

• Registration Number: NCT03541109
• Lead Sponsor: Isfahan University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-30
• Study Start: 2019-05-20
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-11
• Last Update Posted: 2020-10-14
• Primary Completion: 2023-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polypill	Polypill	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

Primary Outcome Measures

Name	Time	Method
A composite clinical outcome of major adverse cardiovascular events (MACE)	from time of randomization up to 34 months	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.

Secondary Outcome Measures

Name	Time	Method
cost-effectiveness of Polypill treatment compared with usual care	up to 34 months	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.

Trial Locations

Locations (2)

Chamran cardiology hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of

Cardiovascular Research Institute; 🇮🇷 Isfahan, Iran, Islamic Republic of