PolyIran.

Trial name or title	PolyIran
Methods	Zelen design, randomised controlled trial nested within the Golestan cohort study (110:90 ratio)
Participants	7000 (2400 in related PolyIran Liver trial) cohort participants over 50 years in Iran followed for 5 years
Interventions	Fixed‐combination therapy (aspirin 80 mg, hydrochlorthiazide 12.5 mg, valsartan 40 mg, and atorvastatin 20 mg (PolyPill 4–2, Alborz‐Darou, Ghazvin, Iran),) + usual care versus usual care alone
Outcomes	Primary outcome major cardiovascular events (non‐fatal myocardial infarction and unstable angina) fatal myocardial infarction sudden death new‐onset heart failure coronary artery revascularization procedures stroke (fatal or non‐fatal) Secondary outcomes all‐cause mortality individual components of the primary outcome liver‐related secondary outcomes: changes in liver stiffness, liver enzyme levels, Visceral Adipose Tissue thickness (VAT), Subcutaneous Adipose Tissue thickness (SAT) and carotid Intima‐media thickness (IMT). Additional secondary outcomes include the proportion of patients with pNASH and pNAFLD. Compliance and adverse events will also be assessed Measured at 2.5 years and 5 years
Starting date	October 2011
Contact information	Reza Malekzadeh MD, Digestive Disease Research Institute, Tehran University of Medical Sciences, Shariati Hospital, 1411713135, Tehran, Iran. Tel: +98 (21) 8241‐5000, Fax: +98 (21) 8241‐5400, E‐mail: malek@tums.ac.ir Tom Marshall MD, School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK. Tel: 44 (0)121 414 7832, Fax: 44 (0)121 414 7878, E‐mail: T.P.Marshall@bham.ac.uk.
Notes	PolyIran protocol: Eur J Prev Cardiol. 2015; 22(12) 1609–1617. PolyIran Liver protocol: Arch Iran Med. 2015; 18(8): 515 – 523. Registriations: NCT00603590, NCT01245608, NCT01271985