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
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 |