Prevention of Cardiovascular Disease Using a Single PolyPill in an Urban Population - Focus on Liver-Related Variables.
Prevention of Cardiovascular Disease Using a Single PolyPill in an Urban Population - Focus on Liver-Related Variables.
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.
2400 subjects will be randomly selected from participants of the Golestan Cohort Study (GCS)
 who are living in Gonbad and are over 50 years old. These subjects will be randomized to
 either receive PolyPill or no treatment.

 Those agreeing to the study will undergo additional measurements (in addition to the baseline
 measurements performed in the GCS) including liver-related tests such as liver enzyme levels,
 abdominal ultrasonography and liver stiffness measurement. Some additional tests such as
 color doppler ultrasonography of carotid vessels will also be performed.

 Subjects in the PolyPill arm who have no contraindication for the components of the pill will
 receive a single daily dose of PolyPill for 5 years.
Inclusion Criteria:

 - Being enrolled in Golestan Cohort Study

 Exclusion Criteria:

 -  Debilitating disease causing inability to comply

 -  Contraindications to any of the components of PolyPill

 -  Not consenting to the study