drugset / Trial / NCT01245608
Prevention of Cardiovascular Disease Using a Single PolyPill in an Urban Population - Focus on Liver-Related Variables.
Phase 3
Completed
2400 enrolled
Tehran University of Medical Sciences
Golestan University of Medical sciences · collabUniversity of Birmingham · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
The primary purpose of this study is to determine the effects of a fixed dose combination of valsartan, hydrochlorothiazide, atorvastatin and aspirin (PolyPill) on prevention of cardiovascular events in adults older than 50. Various liver-related variables will also be recorded which will allow studying the effects of PolyPill on the liver and the effect of liver diseases such as nonalcoholic steatohepatitis on cardiovascular events and the protective effect of PolyPill.
Timeline
- Start
- 2011-10
- Primary completion
- 2018-01
- Completion
- 2018-09
Publications
- Background Pourshams A, Khademi H, Malekshah AF, Islami F, Nouraei M, Sadjadi AR, Jafari E, Rakhshani N, Salahi R, Semnani S, Kamangar F, Abnet CC, Ponder B, Day N, Dawsey SM, Boffetta P, Malekzadeh R. Cohort Profile: The Golestan Cohort Study--a prospective study of oesophageal cancer in northern Iran. Int J Epidemiol. 2010 Feb;39(1):52-9. doi: 10.1093/ije/dyp161. Epub 2009 Mar 30. No abstract available.
- Background Ostovaneh MR, Poustchi H, Hemming K, Marjani H, Pourshams A, Nateghi A, Majed M, Navabakhsh B, Khoshnia M, Jaafari E, Mohammadifard N, Malekzadeh F, Merat S, Sadeghi M, Naemi M, Etemadi A, Thomas GN, Sarrafzadegan N, Cheng KK, Marshall T, Malekzadeh R. Polypill for the prevention of cardiovascular disease (PolyIran): study design and rationale for a pragmatic cluster randomized controlled trial. Eur J Prev Cardiol. 2015 Dec;22(12):1609-17. doi: 10.1177/2047487314550803. Epub 2014 Sep 17.
- Merat S, Jafari E, Radmard AR, Khoshnia M, Sharafkhah M, Nateghi Baygi A, Marshall T, Shiravi Khuzani A, Cheng KK, Poustchi H, Malekzadeh R. Polypill for prevention of cardiovascular diseases with focus on non-alcoholic steatohepatitis: the PolyIran-Liver trial. Eur Heart J. 2022 Jun 1;43(21):2023-2033. doi: 10.1093/eurheartj/ehab919.
- Merat S, Poustchi H, Hemming K, Jafari E, Radmard AR, Nateghi A, Shiravi Khuzani A, Khoshnia M, Marshall T, Malekzadeh R. PolyPill for Prevention of Cardiovascular Disease in an Urban Iranian Population with Special Focus on Nonalcoholic Steatohepatitis: A Pragmatic Randomized Controlled Trial within a Cohort (PolyIran - Liver) - Study Protocol. Arch Iran Med. 2015 Aug;18(8):515-23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 81 mg | Oral |
| Subject | Atorvastatin | Small molecule | 20 mg | Oral |
| Subject | Hydrochlorothiazide | Unknown | 12.5 mg | Oral |
| Subject | Valsartan | Small molecule | 40 mg | Oral |