BACKGROUND: Cardiovascular disease (CVD) is among the most common causes of 
mortality in all populations. Nonalcoholic steatohepatitis is a common finding 
in patients with CVD. Prevention of CVD in individual patients typically 
requires periodic clinical evaluation, as well as diagnosis and management of 
risk factors such as hypertension and hyperlipidemia. However, this is resource 
consuming and hard to implement, especially in developing countries. We designed 
a study to investigate the effects of a simpler strategy: a fixed-dose 
combination pill consisting of aspirin, valsartan, atorvastatin and 
hydrochlorthiazide (PolyPill) in an unselected group of persons aged over 50 
years.
DESIGN: The PolyIran-Liver study was performed in Gonbad city as an open label 
pragmatic randomized controlled trial nested within the Golestan Cohort Study. 
We randomly selected 2,400 cohort study participants aged above 50 years, 
randomly assigned them to intervention or usual care and invited them to 
participate in an additional measurement study (if they met the eligibility 
criteria) to measure liver related outcomes. Those agreeing and randomized to 
the intervention arm were offered a daily single dose of PolyPill. We will 
follow participants for 5 years. The primary outcome is major cardiovascular 
events, secondary outcomes include all-cause mortality and liver related 
outcomes: liver stiffness and liver enzyme levels. Cardiovascular outcomes and 
mortality will be determined from the cohort study and liver-related outcomes in 
those consenting to follow up. Analysis will be by allocated group.
TRIAL STATUS: Between October and December 2011, 1,320 intervention and 1,080 
control participants were invited to participate in the additional measurement 
study. For all these participants, the major cardiovascular events will be 
determined using blind assessment of outcomes through the cohort study. In the 
intervention and control arms, 875 (66%) and 721 (67%) respectively, met the 
eligibility criteria and agreed to participate in the additional measurement 
study. Liver related outcomes will be measured in these participants. Of the 
1,320 participants randomized to the intervention, 787 (60%) accepted the 
PolyPill.
CONCLUSION: The PolyIran-liver urban study will provide us with important 
information on the effectiveness of PolyPill on major cardiovascular events, 
all-cause mortality and liver related outcomes. (ClinicalTrials.gov ID: 
NCT01245608).